PsoriasisPhase 2NCT03706209
Study to Evaluate Efficacy and Safety of MP1032 in Patients With Chronic Plaque Psoriasis
A Phase 2 study testing MP1032 in people with Psoriasis, run by MetrioPharm AG at 19 sites in 2 countries.
Trial summary
The primary objective of this trial is to evaluate the clinical efficacy and safety of two oral doses of MP1032 (150 mg bid and 300 mg bid) when taken for 12 weeks by patients with moderate-to-severe chronic plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- MP1032
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 27 Feb 2018to 12 Jun 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants legally competent to sign and give informed consent.
- Adult male and female patients between 18 years and 70 years with moderate-to-severe chronic plaque psoriasis (diagnosed by Investigator):
- PASI score ≥10 - ≤20 at baseline
- BSA score: > 10%
- Stable disease duration of ≥ 6 months at the initiation of IMP.
- topical therapy fails to control the disease
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- Body Mass Index (BMI) between 18.5 and 34.9 kg/m2.
- Women of childbearing potential (WCBP) must have a negative serum pregnancy test at Screening (Visit 1). In addition, sexually active WCBP must agree to use adequate contraception throughout the trial (see Section 3.2 for more details on adequate contraception):
- A method with less than 1% failure rate OR
- Abstinence
- Post-menopausal women with spontaneous amenorrhea for at least 12 months and women on hormonal replacement therapy (HRT). The use of hormonal replacement therapy (HRT) during the trial is permitted, however for these patients an appropriate contraception method according to Inclusion Criterion 4 must be ensured. Sterilized women may be included (see Section 3.2 for more details on sterile definition)
- Male patients who are sexually active with a female partner and are not surgically sterile (vasectomy performed at least six months prior to treatment) must agree to inform their female sexual partner to use an acceptable form of birth control as described in the informed consent form. For females, an acceptable method (Pearl Index < 1%) would be to use implants, injectable, combined oral contraceptives, some intrauterine devices, or be postmenopausal, be surgically sterile (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy)
- In good health as judged by the investigator, based on medical history, physical examination, serum chemistry, hematology and urinalysis
- Patients must meet the following clinical laboratory criteria:
- White blood cell count ≥3.5 × 109/L
- Platelet count ≥100 × 109/L
- Serum creatinine ≤1.5 × upper limit of normal (ULN); estimated glomerular filtration rate >60 mL/min
- Total bilirubin ≤1.5 × ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN
- Hemoglobin ≥ lower limit of normal as per central laboratory reference ranges for women and men accordingly
- No coagulopathy (International Normalized Ratio [INR] <1.5)
- Patients agree to minimize normal sun exposure during the course of the trial
- Patients are considered reliable and capable of adhering to the protocol (e.g. able to understand the patient information and complete diaries), visit schedule, or medication intake according to the judgment of the Investigator.
Who cannot join
- Patients with non-plaque form of psoriasis (erythrodermic, guttate, pustular form of psoriasis). Associated psoriasis arthritis is allowed provided no other in-/exclusion criteria are influenced, no forbidden concomitant therapy is required for the well -being of the patient and there is no impact on trial objectives as determined by the Investigator.
- Treatment with concomitant medication that may affect and provoke or aggravate psoriasis, e.g. antimalarial drugs, beta-blockers or ACE (angiotensin-converting-enzyme) inhibitors unless on a stable dose for 3 months before IMP intake.
- Evidence of skin conditions at the time of Screening Visit other than psoriasis that would interfere with evaluations of the effect of the IMP on psoriasis.
- Patients with any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the ICF, as assessed by the investigator.
- Pregnant or lactating women or women planning to become pregnant during the trial and / or within 28 days following the last dose of IMP.
- Male patients planning a partner pregnancy or sperm donation during the trial including follow up period.
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- Known allergies to any ingredient of the IMP e.g. mannitol, macrophage modulators, or gelatin.
- History or symptoms of a clinically significant illness in the four weeks before first treatment and during the trial that in the opinion of the investigator may place the patient at risk by trial participation or influence the outcome of the trial. Well controlled diseases such as hypertension, hyperlipidemia, diabetes or hypothyroidism are permitted.
- Patients with active malignancy or history of malignancy, except for basal cell and actinic keratosis. Basal cell carcinoma of the skin or in situ cervical carcinoma that have been fully treated and show no evidence of recurrence are allowed.
- Positive HIV-Antibody, HBs-Antigen or HCV-Antibody-Test at screening.
- Previous strong sun exposure (e.g. sea holiday) within 28 days or UV treatment within 24 weeks before IMP initiation.
- Known photo allergy and / or experienced drug-induced photo toxicity.
- Elective (planned) hospitalization or medical intervention preventing patient from following the protocol requirements.
- Prior treatment not adhering to defined drug classes and related washout periods (Protocol table 2.)
- Planned use of any ultraviolet (UV) phototherapy or photochemotherapy / photosensitizing drugs during the course of the trial and within 28 days/24 weeks following the last dose of the IMP.
- Patients with a history of chronic alcohol or drug abuse within 6 months of IMP initiation.
- Patients with a blood pressure outside the given range of 160 mm Hg (systolic) and 95 mm Hg (diastolic)
- Patients who are employed by MetrioPharm, contract research organization (CRO) or clinical site involved in the clinical trial.
- Vulnerable patients (e.g. patients kept in detention).
- Patients who are unable to communicate, read or understand the local language, or who display another condition, which, in the Investigator's opinion, makes them unsuitable for clinical trial participation.
- Patient is institutionalized because of legal or regulatory order.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
Germany10 sites
Dr. Tsianakas / Dr. Ameluxen
Bad Bentheim
Rothaar Studien GmbH
Berlin
Dr. Johannes Niesmann / Dr. Othlinghaus
Bochum
Klinische Forschung Dresden GmbH
Dresden
MensingDerma
Hamburg
MVZ DermaKiel
Kiel
Hautarztpraxis Dres. med. Scholz, Sebastian, Schilling
Mahlow
Universitätsmedizin Mainz, Hautklinik und Poliklinik
Mainz
Klinische Forschung Schwerin (kfsn)
Schwerin
Centroderm GmbH
Wuppertal
Poland9 sites
GynCentrum Sp. Z o.o.
Katowice
MULTIKLINIKA SALUTE Sp. z o. o.
Katowice
Provita Sp. z o.o., Centrum Medyczne Angelius Provita
Katowice
CENTRUM MEDYCZNE PLEJADY Sp. z o. o. spółka komandytowa
Krakow
Dermoklinika Centrum Medyczne s.c. M.Kierstan, J.Narbutt, A.Lesiak
Lodz
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski
Kliniczny Szpital Wojewódzki nr 1 im. Fryderyka Chopina w Rzeszowie, Klinika Dermatologii
Rzeszów
Laser Clinic s.c. Andrzej Królicki, Tomasz Kochanowski
Szczecin
DermMEDICA Sp. z o.o.
Wroclaw
About this study
Official title: A Phase II, Multicenter, Double-blind, Placebo-controlled, Efficacy and Safety Trial of Two Oral Doses (150 mg Bid / 300 mg Bid) of MP1032 in Male and Female Patients With Moderate-to-Severe Chronic Plaque Psoriasis
The primary objective of this trial is to evaluate the clinical efficacy and safety of two oral doses of MP1032 (150 mg bid and 300 mg bid) when taken for 12 weeks by patients with moderate-to-severe chronic plaque psoriasis.
Read the detailed description
This trial is a randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy and safety of two oral doses of MP1032 (150 mg bid and 300 mg bid) in adult patients with moderate-to-severe chronic plaque psoriasis.
The trial design consists of a 28-day screening period, a 12-week treatment period, and subsequently a 28-day follow-up period. Each patient will have 6 visits and unscheduled visits as needed.
Approximately 150 patients (2 × 50 patients MP1032 and 50 patients placebo) who meet the entry criteria will be randomized on Day 1 to receive either 150 mg MP1032, 300 mg MP1032 or placebo orally twice daily for 12 weeks. The administration of IMP will stop after end of study (in max. 13 weeks).
PASI (Psoriasis Area and Severity Index), PGA (Physician Global Assessment) and BSA (Body Surface Area) Scores will be recorded at predefined timepoints as basis for the efficacy evaluation.
Safety parameter will be monitored from the signing of the informed consent form (ICF) until the last follow-up visit.
To evaluate systemic concentrations of MP1032 PK (pharmacokinetics) samples will be analyzed in a subgroup.
- Conditions
- Psoriasis
- Being tested
- MP1032, Placebo
- Keywords
- moderate to severe, chronic, plaque psoriasis
- Medical subject headings
- Psoriasis, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MP1032Drug
hard gelatin capsules containing 50mg MP1032 as active ingredient
PlaceboDrug
hard gelatin capsules containing no active ingredient
| Study group | Role | What they receive |
|---|---|---|
| 150 mg MP1032 bid | Experimental | 3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) are provided twice daily over a period of 12 weeks. Receives: Drug: MP1032; Drug: Placebo |
| 300 mg MP1032 bid | Experimental | 6 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) are provided twice daily over a period of 12 weeks. Receives: Drug: MP1032 |
| Placebo bid | Placebo comparator | 6 × placebo hard gelatin capsules (per dosage) are provided twice daily over a period of 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PASI 75 - Week 12 (EoT)
Percentage of patients reaching PASI 75 in treatment groups (150 and 300 mg bid) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. The number of responders corresponds to the number of patients with an improvement of at least 75% in the PASI score at End-of-Treatment (EoT) compared to baseline.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA Improvement - Week 12 (EoT)
PGA improvement rate in treatment groups (150 and 300 mg bid) compared to placebo. The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). The number of responders corresponds to the number of patients with an improvement of 1 or more points on the 7-points PGA scale at End-of-Treatment (EoT) compared to baseline.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
Secondary outcomes (50)
PASI 75 VCS - Week 12 (EoT)
Percentage of patients reaching PASI 75 in treatment groups (150 and 300 mg bid) compared to placebo in the valid cases set (VCS). The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. The number of responders corresponds to the number of patients with an improvement of at least 75% in the PASI score at End-of-Treatment (EoT) compared to baseline.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA Improvement VCS - Week 12 (EoT)
PGA improvement rate in treatment groups (150 and 300 mg bid) compared to placebo in the valid-cases-set (VCS). The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). The number of responders corresponds to the number of patients with an improvement of 1 or more points on the 7-points PGA scale at End-of-Treatment (EoT) compared to baseline.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI 50 - Week 12 (EoT)
Percentage of patients reaching PASI 50 in treatment groups (150 and 300 mg bid) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. The number of responders corresponds to the number of patients with an improvement of at least 50% in the PASI score at End-of-Treatment (EoT) compared to baseline.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI ANCOVA Change From Baseline - Week 12 (EoT)
Mean PASI score and change to baseline in treatment groups (150 and 300mg) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. Displayed are changes in the PASI score (LS mean estimates) at end of treatment (EoT) compared to baseline in the different arms in patients of the FAS subject analysis set wherein negative values indicate a better outcome.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI Descriptive Statistics - Week 12 (EoT)
Mean PASI score and change to baseline in treatment groups (150 and 300mg) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. For the change of baseline negative values indicate improvement and positive values indicate worsening.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
Time to PASI 75
Time to the achievement of PASI 75, if applicable. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. Displayed is the number of responders that reached an improvement of at least 75% in the PASI score in the respective week.
Measured: from treatment start (Study Day 1 - Baseline) to either Study Day 25, 56, 84 (EoT) or 112 (FU)
Time to PASI 50
Time to the achievement of PASI 50, if applicable. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. It is a physician's assessment of psoriasis that is a therapeutic standard in clinical studies for this disease. Displayed is the number of responders that reached an improvement of at least 50% in the PASI score in the respective week.
Measured: from treatment start (Study Day 1 - Baseline) to either Study Day 25, 56, 84 (EoT) or 112 (FU)
PGA Descriptive Statistics - Week 12 (EoT)
Mean PGA score and change to baseline in treatment groups (150 and 300mg) compared to placebo at end of treatment. The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). For change from baseline negative values indicate improvement.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA Frequency Counts - Week 12 (EoT)
The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). The 7-point's assessment of psoriasis is a therapeutic standard in clinical studies for this disease. Frequency of the scores from 0 to 6 at end of treatment in the different treatment groups is displayed.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
BSA Descriptive Statistics - Week 12 (EoT)
Mean BSA score and change to baseline in treatment groups (150 and 300mg) compared to placebo at end of treatment. The BSA (Body Surface Area) provides information on the total surface area of the body affected with psoriasis plaques in percent (%).
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI 75 - Week 4
Percentage of patients reaching PASI 75 in treatment groups (150 and 300 mg bid) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. The number of responders corresponds to the number of patients with an improvement of at least 75% in the PASI score at the respective visit (week 4) compared to baseline.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI 75 - Week 8
Percentage of patients reaching PASI 75 in treatment groups (150 and 300 mg bid) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. The number of responders corresponds to the number of patients with an improvement of at least 75% in the PASI score at the respective visit (week 8) compared to baseline.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI 75 - Week 16 (FU)
Percentage of patients reaching PASI 75 in treatment groups (150 and 300 mg bid) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. The number of responders corresponds to the number of patients with an improvement of at least 75% in the PASI score at the respective visit (Follow Up) compared to baseline.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI 50 - Week 4
Percentage of patients reaching PASI 50 in treatment groups (150 and 300 mg bid) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. The number of responders corresponds to the number of patients with an improvement of at least 50% in the PASI score at the respective visit (week 4) compared to baseline.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI 50 - Week 8
Percentage of patients reaching PASI 50 in treatment groups (150 and 300 mg bid) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. The number of responders corresponds to the number of patients with an improvement of at least 50% in the PASI score at the respective visit (week 8) compared to baseline.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI 50 - Week 16 (FU)
Percentage of patients reaching PASI 50 in treatment groups (150 and 300 mg bid) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. The number of responders corresponds to the number of patients with an improvement of at least 50% in the PASI score at the respective visit (Follow Up) compared to baseline.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI ANCOVA Change From Baseline - Week 4
Mean PASI score and change to baseline in treatment groups (150 and 300mg) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. Displayed are changes in the PASI score (LS mean estimates) at the respective visit (week 4) compared to baseline in the different arms in patients of the FAS subject analysis set wherein negative values indicate a better outcome.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI ANCOVA Change From Baseline - Week 8
Mean PASI score and change to baseline in treatment groups (150 and 300mg) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies with a maximum value of 72 points, any value higher than 10 is considered as moderate to severe psoriasis. It is a physician's assessment of psoriasis that is a therapeutic standard in clinical studies for this disease. Displayed are changes in the PASI score (LS mean estimates) at the respective visit (week 8) compared to baseline in the different arms in patients of the FAS subject analysis set wherein negative values indicate a better outcome.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI ANCOVA Change From Baseline - Week 16 (FU)
Mean PASI score and change to baseline in treatment groups (150 and 300mg) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. Displayed are changes in the PASI score (LS mean estimates) at the respective visit (week 16, FU) compared to baseline in the different arms in patients of the FAS subject analysis set wherein negative values indicate a better outcome.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI Descriptive Statistics - Week 4
Mean PASI score and change to baseline in treatment groups (150 and 300mg) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. For the change of baseline negative values indicate improvement and positive values indicate worsening.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI Descriptive Statistics - Week 8
Mean PASI score and change to baseline in treatment groups (150 and 300mg) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. For the change of baseline negative values indicate improvement and positive values indicate worsening.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI Descriptive Statistics - Week 16 (FU)
Mean PASI score and change to baseline in treatment groups (150 and 300mg) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. For the change of baseline negative values indicate improvement and positive values indicate worsening.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA Improvement - Week 4
PGA improvement rate in treatment groups (150 and 300 mg bid) compared to placebo. The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). The number of responders corresponds to the number of patients with an improvement of 1 or more points on the 7-points PGA scale at the respective visit (week 4) compared to baseline.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA Improvement - Week 8
PGA improvement rate in treatment groups (150 and 300 mg bid) compared to placebo. The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). The number of responders corresponds to the number of patients with an improvement of 1 or more points on the 7-points PGA scale at the respective visit (week 8) compared to baseline.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA Improvement - Week 16 (FU)
PGA improvement rate in treatment groups (150 and 300 mg bid) compared to placebo. The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). The number of responders corresponds to the number of patients with an improvement of 1 or more points on the 7-points PGA scale at the respective visit (Follow Up) compared to baseline.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA Descriptive Statistics - Week 4
Mean PGA score and change to baseline in treatment groups (150 and 300mg) compared to placebo at the respective visit (week 4). The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease).
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA Descriptive Statistics - Week 8
Mean PGA score and change to baseline in treatment groups (150 and 300mg) compared to placebo at the respective visit (week 8). The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease).
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA Descriptive Statistics - Week 16 (FU)
Mean PGA score and change to baseline in treatment groups (150 and 300mg) compared to placebo at Follow Up visit. The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease).
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA Frequency Counts - Day 1 (Baseline)
The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). Frequency of different scores at the respective visit (baseline) is displayed.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA Frequency Counts - Week 4
The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). Frequency of different scores at the respective visit (week 4) is displayed.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA Frequency Counts - Week 8
The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). Frequency of different scores at the respective visit (week 8) is displayed.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA Frequency Counts - Week 16 (FU)
The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). Frequency of different scores at follow up visit is displayed.
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
BSA Descriptive Statistics - Week 4
Mean BSA score and change to baseline in treatment groups (150 and 300mg) compared to placebo at the respective visit (week 4). The BSA (Body Surface Area) provides information on the total surface area of the body affected with psoriasis plaques in percent (%).
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
BSA Descriptive Statistics - Week 8
Mean BSA score and change to baseline in treatment groups (150 and 300mg) compared to placebo at the respective visit (week 8). The BSA (Body Surface Area) provides information on the total surface area of the body affected with psoriasis plaques in percent (%).
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
BSA Descriptive Statistics - Week 16 (FU)
Mean BSA score and change to baseline in treatment groups (150 and 300mg) compared to placebo at follow up visit. The BSA (Body Surface Area) provides information on the total surface area of the body affected with psoriasis plaques in percent (%).
Measured: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PK Data - Cmax
The non-compartment parameter Cmax is the maximum MP1032 concentration observed based on the evaluation of systemic MP1032 concentrations in plasma samples wherein the respective blood samples were taken predose and 15, 30, 60 and 120 minutes after dosing.
Measured: Morning dose on Study Day 1
PK Data - Tmax
The non-compartment parameter tmax is the time point (effective) at which the maximum concentration (Cmax) was observed based on the evaluation of systemic MP1032 concentrations in plasma samples wherein the respective blood samples were taken predose and 15, 30, 60 and 120 minutes after dosing.
Measured: Morning dose on Study Day 1
PK Data - AUC(0,t)
The non-compartment parameter AUC(0,t) is the area under the concentration-time curve up to the last quantifiable sample drawn based on the evaluation of systemic MP1032 concentrations in plasma samples wherein the respective blood samples were taken predose and 15, 30, 60 and 120 minutes after dosing.
Measured: Morning dose on Study Day 1
Number of Patients With TEAEs
Number of patients with treatment emergent adverse events (TEAEs) in treatment groups compared to placebo
Measured: Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)
Number of Patients With Serious TEAEs
Number of patients with serious treatment emergent adverse events (TEAEs) in treatment groups compared to placebo
Measured: Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)
Number of Patients With TEAEs Leading to Study Discontinuation
Number of patients with treatment emergent adverse events (TEAEs) leading to study discontinuation in treatment groups compared to placebo
Measured: Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)
Number of Patients With TEAEs by SOC
Number of patients with treatment emergent adverse events (TEAEs) in treatment groups compared to placebo displayed by MedDRA System Organ Classes (SOCs). Only PTs (MedDRA Preferred Terms) occuring in at least 5% of the patients were considered for this overview.
Measured: Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)
Number of Patients With TEAEs by Intensity
Number of patients with treatment emergent adverse events (TEAEs) in treatment groups compared to placebo displayed by severity
Measured: Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)
Number of Patients With TEAEs by Relation to the IMP
Number of patients with treatment emergent adverse events (TEAEs) in treatment groups compared to placebo displayed according to investigators causality assessment.
Measured: Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)
Number of Patients With TEAEs by Causality With the IMP
Number of patients with treatment emergent adverse events (TEAEs) in treatment groups compared to placebo displayed according to investigators causality assessment wherein "certainly", "probably" and "possibly related" were summarized as "related" whereas "unlikely" and "not related" were summarized as "not related".
Measured: Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)
Extent of Exposure - Dosed Capsules
Total (cumulative) number of dosed capsules = 6 * # planned applications - # missed capsules + # overdose capsules.
Planned were 2 applications (a 6 capsules) twice a day over a treatment period of 12 weeks. The number of missed and/or overdosed capsules is determined based on the restitution of used study drug packages.
Measured: overall trial / treatment period - cumulative from baseline to week 12 (EoT) or - if applicable - week16 (FU)
Extent of Exposure - Capsules Per Application
Average number of capsules per application = # dosed capsules / # applications.
Planned were 2 applications (a 6 capsules) twice a day over a treatment period of 12 weeks. The number of missed and/or overdosed capsules is determined based on the restitution of used study drug packages.
Measured: overall trial / treatment period - from baseline to week 12 (EoT) or - if applicable - week16 (FU)
Extent of Exposure - Capsules Per Day
Average number of capsules per day = # dosed capsules / days of treatment.
Planned were 2 applications (a 6 capsules) twice a day over a treatment period of 12 weeks. The number of missed and/or overdosed capsules is determined based on the restitution of used study drug packages.
Measured: overall trial / treatment period - from baseline to week 12 (EoT) or - if applicable - week16 (FU)
Sufficient Extent of Exposure
Exposure was regarded as sufficient if the patient took at least 80% of planned applications (respectively capsules) wherein % exposure was calculated as 100 * # dosed capsules / # planned capsules.
Planned were 2 applications (a 6 capsules) twice a day over a treatment period of 12 weeks (i.e. 1008 capsules). The number of missed and/or overdosed capsules is determined based on the restitution of used study drug packages.
Measured: overall trial / treatment period - cumulative from baseline to week 12 (EoT) or - if applicable - week16 (FU)
Extent of Exposure - Treatment Duration
Treatment duration = date of last dose - date of first dose + 1. 84 treatment days (12 weeks) were planned.
Measured: overall trial / treatment period - cumulative from baseline to week 4, 8, 12 (EoT), and - if applicable - week16 (FU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start27 Feb 2018
- Primary completion12 Jun 2019
- Study completion12 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm randomized, double-blind, placebo-controlled, parallel group phase II multi-center trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetrioPharm AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bioskin GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706209
- Sponsor's protocol ID
- MP1032-CT04
- Other IDs
- 2017-003484-36, 2017
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2018
- Last updated
- 22 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Double-blind, Placebo-controlled, Efficacy and Safety Trial of Two Oral Doses (150 mg Bid / 300 mg Bid) of MP1032 in Male and Female Patients With Moderate-to-Severe Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT03706209
- Acronym / sponsor ID
- MP1032-CT04
- Conditions
- Psoriasis
- Keywords
- moderate to severe, chronic, plaque psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- MetrioPharm AGIndustry (pharma, biotech, devices)
- Collaborators
- Bioskin GmbH
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 12 Jun 2019 (actual)
- Study completion
- 12 Jun 2019 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Posted 22 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to evaluate the clinical efficacy and safety of two oral doses of MP1032 (150 mg bid and 300 mg bid) when taken for 12 weeks by patients with moderate-to-severe chronic plaque psoriasis.
Detailed description
This trial is a randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy and safety of two oral doses of MP1032 (150 mg bid and 300 mg bid) in adult patients with moderate-to-severe chronic plaque psoriasis.
The trial design consists of a 28-day screening period, a 12-week treatment period, and subsequently a 28-day follow-up period. Each patient will have 6 visits and unscheduled visits as needed.
Approximately 150 patients (2 × 50 patients MP1032 and 50 patients placebo) who meet the entry criteria will be randomized on Day 1 to receive either 150 mg MP1032, 300 mg MP1032 or placebo orally twice daily for 12 weeks. The administration of IMP will stop after end of study (in max. 13 weeks).
PASI (Psoriasis Area and Severity Index), PGA (Physician Global Assessment) and BSA (Body Surface Area) Scores will be recorded at predefined timepoints as basis for the efficacy evaluation.
Safety parameter will be monitored from the signing of the informed consent form (ICF) until the last follow-up visit.
To evaluate systemic concentrations of MP1032 PK (pharmacokinetics) samples will be analyzed in a subgroup.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm randomized, double-blind, placebo-controlled, parallel group phase II multi-center trial
| Arm | Type | Receives |
|---|---|---|
| 150 mg MP1032 bid | Experimental | Drug: MP1032, Drug: Placebo3 × 50 mg (150 mg) MP1032 plus 3 × placebo hard gelatin capsules (per dosage) are provided twice daily over a period of 12 weeks. |
| 300 mg MP1032 bid | Experimental | Drug: MP10326 × 50 mg (300 mg) MP1032 hard gelatin capsules (per dosage) are provided twice daily over a period of 12 weeks. |
| Placebo bid | Placebo comparator | Drug: Placebo6 × placebo hard gelatin capsules (per dosage) are provided twice daily over a period of 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Participants legally competent to sign and give informed consent.
- Adult male and female patients between 18 years and 70 years with moderate-to-severe chronic plaque psoriasis (diagnosed by Investigator):
- Body Mass Index (BMI) between 18.5 and 34.9 kg/m2.
- Women of childbearing potential (WCBP) must have a negative serum pregnancy test at Screening (Visit 1). In addition, sexually active WCBP must agree to use adequate contraception throughout the trial (see Section 3.2 for more details on adequate contraception):
- Post-menopausal women with spontaneous amenorrhea for at least 12 months and women on hormonal replacement therapy (HRT). The use of hormonal replacement therapy (HRT) during the trial is permitted, however for these patients an appropriate contraception method according to Inclusion Criterion 4 must be ensured. Sterilized women may be included (see Section 3.2 for more details on sterile definition)
Key exclusion criteria (21 listed)
- Patients with non-plaque form of psoriasis (erythrodermic, guttate, pustular form of psoriasis). Associated psoriasis arthritis is allowed provided no other in-/exclusion criteria are influenced, no forbidden concomitant therapy is required for the well -being of the patient and there is no impact on trial objectives as determined by the Investigator.
- Treatment with concomitant medication that may affect and provoke or aggravate psoriasis, e.g. antimalarial drugs, beta-blockers or ACE (angiotensin-converting-enzyme) inhibitors unless on a stable dose for 3 months before IMP intake.
- Evidence of skin conditions at the time of Screening Visit other than psoriasis that would interfere with evaluations of the effect of the IMP on psoriasis.
- Patients with any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the ICF, as assessed by the investigator.
- Pregnant or lactating women or women planning to become pregnant during the trial and / or within 28 days following the last dose of IMP.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MP1032hard gelatin capsules containing 50mg MP1032 as active ingredient | Drug | 150 mg MP1032 bid, 300 mg MP1032 bid |
| Placebohard gelatin capsules containing no active ingredient | Drug | 150 mg MP1032 bid, Placebo bid |
Primary outcome
PASI 75 - Week 12 (EoT)
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
Percentage of patients reaching PASI 75 in treatment groups (150 and 300 mg bid) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. The number of responders corresponds to the number of patients with an improvement of at least 75% in the PASI score at End-of-Treatment (EoT) compared to baseline.
PGA Improvement - Week 12 (EoT)
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA improvement rate in treatment groups (150 and 300 mg bid) compared to placebo. The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). The number of responders corresponds to the number of patients with an improvement of 1 or more points on the 7-points PGA scale at End-of-Treatment (EoT) compared to baseline.
50 secondary outcomes
PASI 75 VCS - Week 12 (EoT)
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA Improvement VCS - Week 12 (EoT)
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI 50 - Week 12 (EoT)
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI ANCOVA Change From Baseline - Week 12 (EoT)
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI Descriptive Statistics - Week 12 (EoT)
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
Time to PASI 75
Time frame: from treatment start (Study Day 1 - Baseline) to either Study Day 25, 56, 84 (EoT) or 112 (FU)
Time to PASI 50
Time frame: from treatment start (Study Day 1 - Baseline) to either Study Day 25, 56, 84 (EoT) or 112 (FU)
PGA Descriptive Statistics - Week 12 (EoT)
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA Frequency Counts - Week 12 (EoT)
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
BSA Descriptive Statistics - Week 12 (EoT)
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI 75 - Week 4
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI 75 - Week 8
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI 75 - Week 16 (FU)
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI 50 - Week 4
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI 50 - Week 8
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI 50 - Week 16 (FU)
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI ANCOVA Change From Baseline - Week 4
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI ANCOVA Change From Baseline - Week 8
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI ANCOVA Change From Baseline - Week 16 (FU)
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI Descriptive Statistics - Week 4
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI Descriptive Statistics - Week 8
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PASI Descriptive Statistics - Week 16 (FU)
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA Improvement - Week 4
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA Improvement - Week 8
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA Improvement - Week 16 (FU)
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA Descriptive Statistics - Week 4
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA Descriptive Statistics - Week 8
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA Descriptive Statistics - Week 16 (FU)
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA Frequency Counts - Day 1 (Baseline)
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA Frequency Counts - Week 4
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA Frequency Counts - Week 8
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PGA Frequency Counts - Week 16 (FU)
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
BSA Descriptive Statistics - Week 4
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
BSA Descriptive Statistics - Week 8
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
BSA Descriptive Statistics - Week 16 (FU)
Time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
PK Data - Cmax
Time frame: Morning dose on Study Day 1
PK Data - Tmax
Time frame: Morning dose on Study Day 1
PK Data - AUC(0,t)
Time frame: Morning dose on Study Day 1
Number of Patients With TEAEs
Time frame: Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)
Number of Patients With Serious TEAEs
Time frame: Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MP1032 in people with Psoriasis, run by MetrioPharm AG at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PASI 75 - Week 12 (EoT) (time frame: Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.