PsoriasisPhase 2NCT02908347
Study to Evaluate Safety and Efficacy of Oral MP1032 in Psoriasis Patients
A Phase 2 study testing MP1032 in people with Psoriasis and Plaque Psoriasis, run by MetrioPharm AG at 4 sites in Germany.
Trial summary
This Phase IIa study is designed to assess the safety, tolerability and pharmacokinetics of oral MP1032 in patients with moderate to severe psoriasis over a period of 6 weeks. Secondary endpoints to evaluate clinical parameters for psoriasis during the 6 week treatment period and a 4-week follow up will provide an… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis, Plaque 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
- 46 participants
- Where
- 4 sitesGermany
- Study dates
- May 2016to Feb 2017
- 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 65 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 aged 18 to 65 years with chronic plaque psoriasis:
- PASI score > 10 at screening and
- Disease duration of ≥ 6 months at the initiation of study medication.
- Body Mass Index (BMI) between 18.5 and 34.9 kg/m2.
- Diagnosis of chronic plaque psoriasis confirmed by a dermatologist/physician.
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- Women of childbearing potential (WCBP) must have a negative urine pregnancy test at Screening (Visit 1). In addition, sexually active WCBP must agree to use 2 forms of adequate contraception throughout the trial.
- Post-menopausal women with spontaneous amenorrhea for at least 12 months and serum levels follicle stimulating hormone (FSH) Levels indicating post-menopausal state as per local laboratory reference ranges. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2 to 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study. Sterilized women may be included.
- Patients must meet the following clinical laboratory criteria:
- White blood cell count ≥ 3.5 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN); estimated glomerular filtration rate > 60 mL/min
- Total bilirubin ≤ 1.5 x ULN
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 1.5 x ULN
- Hemoglobin ≥ lower limit of normal as per local laboratory reference ranges for women and men accordingly
- No coagulopathy (International Normalized Ratio [INR] < 1.5).
- Patients agree not to increase normal sun exposure during the course of the study.
- Patients are able to swallow 2 small capsules during each administration.
- Patients are considered reliable and capable of adhering to the protocol (eg, able to understand 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 or palmo plantar psoriasis; severe form of psoriasis arthritis, inverse form of psoriasis). Mild to moderate cases of psoriasis arthritis are allowed provided there is no impact on study objectives as determined by the Investigator.
- Patients with drug-induced psoriasis.
- Evidence of skin conditions at the time of screening visit other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
- Patients with any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form.
- Pregnant or lactating females or females planning to become pregnant during the study and/or within 28 days following the last dose of study medication.
- Male patients planning a partner pregnancy or sperm donation during the study or within 3 months following the last dose of study medication.
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- Known allergies to mannitol, macrophage modulators, and gelatin.
- Patients with a recent history or current signs or symptoms, as determined by the Investigator, of severe, progressive viral or bacterial infections, of clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic insufficiency disease (excluding psoriasis) requiring systemic treatment or other major diseases, which are not well controlled and may interfere with the conduct of the trial.
- Patients with active malignancy or history of malignancy, except for basal cell or squamous cell carcinoma and actinic keratosis. Basal cell carcinoma and small squamous cell carcinoma of the skin which have been excised according to guidelines within the last 5 years or in situ cervical carcinoma that has been fully treated and shows no evidence of recurrence are allowed.
- Clinically significant abnormality on 12-lead electrocardiogram (ECG) at screening.
- Positive human immunodeficiency virus (HIV), hepatitis B or hepatitis C laboratory result.
- Previous strong sun exposure (eg, sea holiday) within the 28 days before study medication 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: Drug class >> Last dose prior to study medication initiation (washout period)
- Topical psoriasis medications (including, but not limited to corticosteroids, calcipotriene, topical vitamin D derivates, retinoids, coal tar) >> 14 days
- Topical immunosuppressive drugs (tacrolimus, pimecrolimus, or anthralin) >> 14 days (Exception: Non-medicated emollients, moisturizers and sunscreens will be allowed), Use of low potency topical steroids for critical areas such as the face, genitalia, and scalp may be allowed until 24 hours prior to randomization.
- Systemic treatment (non-biologic): Systemic immunosuppressant agents (eg: methotrexate, cyclosporine, azathioprine), Systemic fumarate, Systemic corticosteroids >> 28 days
- Phototherapy or photochemotherapy/photosensitizing drugs >> 28 days
- Systemic retinoids >> 12 weeks
- Any investigational drug >> 24 weeks (systemic); 4 weeks (topical)
- Any Anti-TNFs: Infliximab, adalimumab, golimumab, etanercept, etc. >> 12 weeks
- Other Biologics and other systemic therapies: ustekinumab, alefacept, apremilast, Efalizumab, certolizumab pegol, secukinumab, etc. >> 24 weeks
- Rituximab >> 12 months
- Drinking or ingesting grapefruit, pomegranate, grapefruit juice or grapefruit containing products within 14 days of study medication initiation.
- Planned use of any ultraviolet (UV) phototherapy or photochemotherapy/photosensitizing drugs during the course of the study and within 28 days following the last dose of the study medication.
- Patients with a history of chronic alcohol or drug abuse within 6 months of study medication initiation.
- Patients employed by MetrioPharm or a contract research organization (CRO) involved in the clinical study.
- Vulnerable patients (eg, patients kept in detention).
- Patients who are unable to communicate, read and understand the local language, or who display any other condition, which, in the Investigator's opinion, makes them unsuitable for clinical study participation.
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Rothaar Studien GmbH
Berlin, 10783
PAREXEL International GmbH, Klinikum Westend
Berlin, 14050
Klinische Forschung Dresden GmbH
Dresden, 01069
Gemeinschaftspraxis Prof. Dr. Vanscheidt und Dr. Ukat
Freiburg im Breisgau, 79100
About this study
Official title: A Randomized (1:1), Double-blind, Parallel, Placebo-controlled Exploratory Pilot Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Systemic (po) Application of MP1032 in Patients With Moderate to Severe Chronic Plaque Psoriasis
This Phase IIa study is designed to assess the safety, tolerability and pharmacokinetics of oral MP1032 in patients with moderate to severe psoriasis over a period of 6 weeks. Secondary endpoints to evaluate clinical parameters for psoriasis during the 6 week treatment period and a 4-week follow up will provide an opportunity to perform a first assessment of oral MP1032's clinical efficacy in the treatment of moderate to severe psoriasis.
The study population will consist of 44 enrolled (40 completed) patients with moderate to severe chronic plaque psoriasis. Patients must be able to provide written consent and meet all the inclusion criteria and none of the exclusion criteria.
Read the detailed description
This study is a randomized, double-blind, parallel, placebo-controlled exploratory pilot study to evaluate safety, pharmacokinetics and efficacy of systemic oral (po) administration of 100 mg MP1032 bid in adult patients with moderate to severe chronic plaque psoriasis.
The study design consists of a 28-day screening/run-in period, a 42-day treatment period, 1 day for the End of Treatment visit, and a 28-day follow-up period. Forty-four patients who meet the entry criteria will be randomized on Day 1 in a 1:1 ratio to receive either 100 mg MP1032 or placebo orally twice daily for 42 days. The goal is to have 40 patients (20 in each treatment group) complete the study.
Pharmacokinetic sampling will occur on 3 designated study days. Safety will be monitored from the signing of the informed consent form (ICF) until the last follow-up visit on Day 71.
Efficacy will be assessed on 6 designated study days using the following assessments: PASI, PGA, DLQI, mNAPSI, and EQ-5D 5L (VAS).
- Conditions
- Psoriasis, Plaque Psoriasis
- Being tested
- MP1032, Placebo
- Keywords
- Plaque psoriasis, chronic, moderate, severe, Plaque
- Medical subject headings
- Psoriasis, Bronchiolitis Obliterans Syndrome, Lymphoma, Follicular, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MP1032Drug
hard gelatine capsules containing 50 mg MP1032 as active ingredient
PlaceboDrug
hard gelatine capsules without active ingredient
| Study group | Role | What they receive |
|---|---|---|
| MP1032 | Experimental | Test Product:
100 mg MP1032 (= 2 capsules a 50 mg) are provided orally twice daily for 42 days Receives: Drug: MP1032 |
| Placebo | Experimental | Placebo to MP1032:
2 capsules of Placebo are provided orally twice daily for 42 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs
Number of TEAEs (Treatment Emergent Adverse Events) occured was determined by treatment group.
Furthermore, the absolute and relative frequencies for patients with a given AE, as well as the number of events of the individual AEs that have occurred throughout the study (inclusive screening), were determined within each treatment group and system organ class. Results thereto are provided in the section "Reported Adverse Events".
AEs are collected throughout the study. Abnormal values received from Clinical Laboratory Safety Testing (hematology, biochemistry and urinalysis on Study Days 1, 15, 29, 43, 57 and 71), Vital Signs (Systolic blood pressure, diastolic blood pressure, heart rate, tympanic body temperature and respiration rate on Study Days 1, 15, 29, 43, 57 and 71), ECG (Study Days 1, 43 and 71) and Physical Examination (Study Days 1, 43 and 71) were also handled as AE.
Measured: Continuously from Treatment Start until the last follow-up visit on Study Day 71
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Related TEAEs by SOC
Number of related TEAEs (Treatment Emergent Adverse Events) occured by SOC (System Organ class) was determined by treatment group.
Furthermore, the absolute and relative frequencies for patients with a given AE, as well as the number of events of the individual AEs that have occurred throughout the study (inclusive screening), were determined within each treatment group and system organ class. Results thereto are provided in the section "Reported Adverse Events".
AEs are collected throughout the study. Abnormal values received from Clinical Laboratory Safety Testing (hematology, biochemistry and urinalysis on Study Days 1, 15, 29, 43, 57 and 71), Vital Signs (Systolic blood pressure, diastolic blood pressure, heart rate, tympanic body temperature and respiration rate on Study Days 1, 15, 29, 43, 57 and 71), ECG (Study Days 1, 43 and 71) and Physical Examination (Study Days 1, 43 and 71) were also handled as AE.
Measured: Continuously from Treatment Start until the last follow-up visit on Study Day 71
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With TEAEs
Number of patients with TEAEs (Treatment Emergent Adverse Events) was determined by treatment group.
Furthermore, the absolute and relative frequencies for patients with a given AE, as well as the number of events of the individual AEs that have occurred throughout the study (inclusive screening), were determined within each treatment group and system organ class. Results thereto are provided in the section "Reported Adverse Events".
AEs are collected throughout the study. Abnormal values received from Clinical Laboratory Safety Testing (hematology, biochemistry and urinalysis on Study Days 1, 15, 29, 43, 57 and 71), Vital Signs (Systolic blood pressure, diastolic blood pressure, heart rate, tympanic body temperature and respiration rate on Study Days 1, 15, 29, 43, 57 and 71), ECG (Study Days 1, 43 and 71) and Physical Examination (Study Days 1, 43 and 71) were also handled as AE.
Measured: Continuously from Treatment Start until the last follow-up visit on Study Day 71
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With Related TEAEs by SOC
Number of patients with related TEAEs (Treatment Emergent Adverse Events) occured by SOC (System Organ class) was determined by treatment group.
Furthermore, the absolute and relative frequencies for patients with a given AE, as well as the number of events of the individual AEs that have occurred throughout the study (inclusive screening), were determined within each treatment group and system organ class. Results thereto are provided in the section "Reported Adverse Events".
AEs are collected throughout the study. Abnormal values received from Clinical Laboratory Safety Testing (hematology, biochemistry and urinalysis on Study Days 1, 15, 29, 43, 57 and 71), Vital Signs (Systolic blood pressure, diastolic blood pressure, heart rate, tympanic body temperature and respiration rate on Study Days 1, 15, 29, 43, 57 and 71), ECG (Study Days 1, 43 and 71) and Physical Examination (Study Days 1, 43 and 71) were also handled as AE.
Measured: Continuously from Treatment Start until the last follow-up visit on Study Day 71
Pharmacokinetics (PK) - Plasma Concentrations
Study Day 1 - sampling 15 minutes, 30 minutes, 1 hour and 2 hours postdose Study Days 15, 29 and 43 - only one sample was taken any time postdose (time of the last dose was recorded).
No statistical Evaluation has been performed.
Measured: Study Days 1, 15, 29 and 43
Pharmacokinetics (PK) - Maximum Observed Concentration (Cmax)
Maximum observed plasma concentration (Cmax)as observed on Day 1 with sampling times of 15 minutes, 30 minutes, 1 hour, and 2 hours postdose
Measured: Study Day 1
Pharmacokinetics (PK) - Time
Sampling 15 minutes, 30 minutes, 1 hour, and 2 hours postdose
t max = Time corresponding to occurence of Cmax t last = Time of last quantifiable concentration
Measured: Study Day 1
Pharmacokinetics (PK) - Area Under the Curve (AUC)
AUC (lin-log) - Sampling 15 minutes, 30 minutes, 1 hour, and 2 hours postdose
AUC 2h = area under the plasma concentration-time curve from time zero to 2 hours AUC t = area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
Measured: Study Day 1
Pharmacokinetics (PK) - Area Under the Curve (AUC) - Subgroups
AUC (lin-log) - Sampling 15 minutes, 30 minutes, 1 hour, and 2 hours postdose
AUC 2h = area under the plasma concentration-time curve from time zero to 2 hours AUC t = area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
Measured: Study Day 1
Secondary outcomes (10)
Psoriasis Area Severity Index (PASI) - Observed PASI Values
Observed PASI values. PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.
No formal hypothesis testing, variables are summarized by descriptive statistics (n, mean, SD, ).
Measured: Study Day 1, 43, 57 and 71
Psoriasis Area Severity Index (PASI) - Change From Baseline
Change from Baseline (PASI value Day 43 - PASI value at Day 1) / Treatment difference on Day 43
PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.
Variables will be summarized by descriptive statistics (n, mean, SD), difference between groups is analyzed via non-parametric statistical testing.
Measured: Study Day 1 and 43
Psoriasis Area Severity Index (PASI) - PASI Percentage Change - Including Subgroup Analysis AUC2h
The PASI percentage change in % at Day 29 is calculated as PASI of (Day 29 - Baseline)/Baseline*100).
The PASI percentage change in % at Day 43 is calculated as PASI of (Day 43 - Baseline)/Baseline*100).
Baseline = Study Day 1
PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.
No formal hypothesis testing, variables are summarized by descriptive statistics (n, mean, SD).
Measured: Study Day 1, 29 and 43
Psoriasis Area Severity Index (PASI) - PASI Percentage Change - Including Subgroup Analysis AUCt
The PASI percentage change in % at Day 29 is calculated as PASI of (Day 29 - Baseline)/Baseline*100).
The PASI percentage change in % at Day 43 is calculated as PASI of (Day 43 - Baseline)/Baseline*100).
Baseline = Study Day 1
PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.
No formal hypothesis testing, variables are summarized by descriptive statistics (n, mean, SD).
Measured: Study Day 1, 29 and 43
Psoriasis Area Severity Index (PASI) - PASI 30 and PASI 50 - Number of Patients
PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.
PASI 30 and PASI 50 are related to the number of patients who had at least 30% (PASI 30) or 50% (PASI 50) reduction in PASI score compared to baseline (Study Day 1).
Variables are summarized by descriptive statistics (n, mean, SD, ). Difference between groups has been analyzed via Fisher exact test.
Measured: Study Day 1, 29 and 43
Psoriasis Area Severity Index (PASI) - PASI 30 and PASI 50 - Responder Frequency
PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.
PASI 30 and PASI 50 are related to the number of patients (responder frequency (%)) who had at least 30% (PASI 30) or 50% (PASI 50) reduction in PASI score compared to baseline (Study Day 1).
Variables are summarized by descriptive statistics (n, mean, SD, ).
Measured: Study Day 1, 29 and 43
Physician's Global Assessment (PGA) - Observed Values and Change From Baseline
PGA is the physician's global assessment of the severity of psoriasis using a 7-point scale from 0 (clear) to 6 (severe).
No formal hypothesis testing, variables will be summarized by descriptive statistics (n, mean, SD) for absolute values and changes from baseline (Study Day 1) at Study Day 43 (End of Treatment).
Measured: Study Day 1 and 43
Dermatology Life Quality Index (DLQI) - Observed Values and Change From Baseline.
DLQI is a total score ranging from 0 (life quality is not affected) to 30 (deep impact on life quality) computed from answers to 10 questions, with each answer scored from 0 (not at all) to 3 (very much).
No formal hypothesis testing, variables will be summarized by descriptive statistics (n, mean, SD) for absolute values and changes from baseline (Study Day 1) on end of treatment (Day 43).
Measured: Study Day 1 and 43
EQ-5D 5L Visual Analogue Scale (VAS)
EQ-5D (VAS) is a total score which records the patients' self-rated health status with the scale numbered 0 (worst imaginable) to 100 (best imaginable)
No formal hypothesis testing, variables will be summarized by descriptive statistics (n, mean, SD) for absolute values and changes from baseline (Study Day 1) at end of Treatment (Study Day 43).
Measured: Study Day 1 and 43
Modified Nail Psoriasis Severity Index (mNAPSI) - Observed Values and Change From Baseline
mNAPSI score is a total score computed from answers to 7 questions, 3 of which can be answered with a score ranging from 0 to 3, and 4 of which can be answered with a score ranging from 0 to 1. The total score ranges from 0 to 13, the higher the score the worse the outcome.
No formal hypothesis testing, variables will be summarized by descriptive statistics (n, mean, SD) for absolute values and changes from baseline (Study Day 1) at end of Treatment (Study Day 43).
Measured: Study Day 1 and 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2016
- Study completionFeb 2017
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetrioPharm AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Anke Gauliard, MD, Principal investigator, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908347
- Sponsor's protocol ID
- MP1032-CT02
- Status last verified
- Jan 2019
- First submitted
- 23 Jun 2016
- Last updated
- 23 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized (1:1), Double-blind, Parallel, Placebo-controlled Exploratory Pilot Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Systemic (po) Application of MP1032 in Patients With Moderate to Severe Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT02908347
- Acronym / sponsor ID
- MP1032-CT02
- Conditions
- Psoriasis, Plaque Psoriasis
- Keywords
- Plaque psoriasis, chronic, moderate, severe, Plaque
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- MetrioPharm AGIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- May 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Posted 23 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase IIa study is designed to assess the safety, tolerability and pharmacokinetics of oral MP1032 in patients with moderate to severe psoriasis over a period of 6 weeks. Secondary endpoints to evaluate clinical parameters for psoriasis during the 6 week treatment period and a 4-week follow up will provide an opportunity to perform a first assessment of oral MP1032's clinical efficacy in the treatment of moderate to severe psoriasis.
The study population will consist of 44 enrolled (40 completed) patients with moderate to severe chronic plaque psoriasis. Patients must be able to provide written consent and meet all the inclusion criteria and none of the exclusion criteria.
Detailed description
This study is a randomized, double-blind, parallel, placebo-controlled exploratory pilot study to evaluate safety, pharmacokinetics and efficacy of systemic oral (po) administration of 100 mg MP1032 bid in adult patients with moderate to severe chronic plaque psoriasis.
The study design consists of a 28-day screening/run-in period, a 42-day treatment period, 1 day for the End of Treatment visit, and a 28-day follow-up period. Forty-four patients who meet the entry criteria will be randomized on Day 1 in a 1:1 ratio to receive either 100 mg MP1032 or placebo orally twice daily for 42 days. The goal is to have 40 patients (20 in each treatment group) complete the study.
Pharmacokinetic sampling will occur on 3 designated study days. Safety will be monitored from the signing of the informed consent form (ICF) until the last follow-up visit on Day 71.
Efficacy will be assessed on 6 designated study days using the following assessments: PASI, PGA, DLQI, mNAPSI, and EQ-5D 5L (VAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MP1032 | Experimental | Drug: MP1032Test Product: 100 mg MP1032 (= 2 capsules a 50 mg) are provided orally twice daily for 42 days |
| Placebo | Experimental | Drug: PlaceboPlacebo to MP1032: 2 capsules of Placebo are provided orally twice daily for 42 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Participants legally competent to sign and give informed consent.
- Adult male and female patients aged 18 to 65 years with chronic plaque psoriasis:
- Body Mass Index (BMI) between 18.5 and 34.9 kg/m2.
- Diagnosis of chronic plaque psoriasis confirmed by a dermatologist/physician.
- Women of childbearing potential (WCBP) must have a negative urine pregnancy test at Screening (Visit 1). In addition, sexually active WCBP must agree to use 2 forms of adequate contraception throughout the trial.
Key exclusion criteria (30 listed)
- Patients with non-plaque form of psoriasis (erythrodermic, guttate, pustular or palmo plantar psoriasis; severe form of psoriasis arthritis, inverse form of psoriasis). Mild to moderate cases of psoriasis arthritis are allowed provided there is no impact on study objectives as determined by the Investigator.
- Patients with drug-induced psoriasis.
- Evidence of skin conditions at the time of screening visit other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
- Patients with any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form.
- Pregnant or lactating females or females planning to become pregnant during the study and/or within 28 days following the last dose of study medication.
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 gelatine capsules containing 50 mg MP1032 as active ingredient | Drug | MP1032 |
| Placebohard gelatine capsules without active ingredient | Drug | Placebo |
Primary outcome
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs
Time frame: Continuously from Treatment Start until the last follow-up visit on Study Day 71
Number of TEAEs (Treatment Emergent Adverse Events) occured was determined by treatment group. Furthermore, the absolute and relative frequencies for patients with a given AE, as well as the number of events of the individual AEs that have occurred throughout the study (inclusive screening), were determined within each treatment group and system organ class. Results thereto are provided in the section "Reported Adverse Events". AEs are collected throughout the study. Abnormal values received from Clinical Laboratory Safety Testing (hematology, biochemistry and urinalysis on Study Days 1, 15, 29, 43, 57 and 71), Vital Signs (Systolic blood pressure, diastolic blood pressure, heart rate, tympanic body temperature and respiration rate on Study Days 1, 15, 29, 43, 57 and 71), ECG (Study Days 1, 43 and 71) and Physical Examination (Study Days 1, 43 and 71) were also handled as AE.
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Related TEAEs by SOC
Time frame: Continuously from Treatment Start until the last follow-up visit on Study Day 71
Number of related TEAEs (Treatment Emergent Adverse Events) occured by SOC (System Organ class) was determined by treatment group. Furthermore, the absolute and relative frequencies for patients with a given AE, as well as the number of events of the individual AEs that have occurred throughout the study (inclusive screening), were determined within each treatment group and system organ class. Results thereto are provided in the section "Reported Adverse Events". AEs are collected throughout the study. Abnormal values received from Clinical Laboratory Safety Testing (hematology, biochemistry and urinalysis on Study Days 1, 15, 29, 43, 57 and 71), Vital Signs (Systolic blood pressure, diastolic blood pressure, heart rate, tympanic body temperature and respiration rate on Study Days 1, 15, 29, 43, 57 and 71), ECG (Study Days 1, 43 and 71) and Physical Examination (Study Days 1, 43 and 71) were also handled as AE.
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With TEAEs
Time frame: Continuously from Treatment Start until the last follow-up visit on Study Day 71
Number of patients with TEAEs (Treatment Emergent Adverse Events) was determined by treatment group. Furthermore, the absolute and relative frequencies for patients with a given AE, as well as the number of events of the individual AEs that have occurred throughout the study (inclusive screening), were determined within each treatment group and system organ class. Results thereto are provided in the section "Reported Adverse Events". AEs are collected throughout the study. Abnormal values received from Clinical Laboratory Safety Testing (hematology, biochemistry and urinalysis on Study Days 1, 15, 29, 43, 57 and 71), Vital Signs (Systolic blood pressure, diastolic blood pressure, heart rate, tympanic body temperature and respiration rate on Study Days 1, 15, 29, 43, 57 and 71), ECG (Study Days 1, 43 and 71) and Physical Examination (Study Days 1, 43 and 71) were also handled as AE.
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With Related TEAEs by SOC
Time frame: Continuously from Treatment Start until the last follow-up visit on Study Day 71
Number of patients with related TEAEs (Treatment Emergent Adverse Events) occured by SOC (System Organ class) was determined by treatment group. Furthermore, the absolute and relative frequencies for patients with a given AE, as well as the number of events of the individual AEs that have occurred throughout the study (inclusive screening), were determined within each treatment group and system organ class. Results thereto are provided in the section "Reported Adverse Events". AEs are collected throughout the study. Abnormal values received from Clinical Laboratory Safety Testing (hematology, biochemistry and urinalysis on Study Days 1, 15, 29, 43, 57 and 71), Vital Signs (Systolic blood pressure, diastolic blood pressure, heart rate, tympanic body temperature and respiration rate on Study Days 1, 15, 29, 43, 57 and 71), ECG (Study Days 1, 43 and 71) and Physical Examination (Study Days 1, 43 and 71) were also handled as AE.
Pharmacokinetics (PK) - Plasma Concentrations
Time frame: Study Days 1, 15, 29 and 43
Study Day 1 - sampling 15 minutes, 30 minutes, 1 hour and 2 hours postdose Study Days 15, 29 and 43 - only one sample was taken any time postdose (time of the last dose was recorded). No statistical Evaluation has been performed.
Pharmacokinetics (PK) - Maximum Observed Concentration (Cmax)
Time frame: Study Day 1
Maximum observed plasma concentration (Cmax)as observed on Day 1 with sampling times of 15 minutes, 30 minutes, 1 hour, and 2 hours postdose
Pharmacokinetics (PK) - Time
Time frame: Study Day 1
Sampling 15 minutes, 30 minutes, 1 hour, and 2 hours postdose t max = Time corresponding to occurence of Cmax t last = Time of last quantifiable concentration
Pharmacokinetics (PK) - Area Under the Curve (AUC)
Time frame: Study Day 1
AUC (lin-log) - Sampling 15 minutes, 30 minutes, 1 hour, and 2 hours postdose AUC 2h = area under the plasma concentration-time curve from time zero to 2 hours AUC t = area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
Pharmacokinetics (PK) - Area Under the Curve (AUC) - Subgroups
Time frame: Study Day 1
AUC (lin-log) - Sampling 15 minutes, 30 minutes, 1 hour, and 2 hours postdose AUC 2h = area under the plasma concentration-time curve from time zero to 2 hours AUC t = area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
10 secondary outcomes
Psoriasis Area Severity Index (PASI) - Observed PASI Values
Time frame: Study Day 1, 43, 57 and 71
Psoriasis Area Severity Index (PASI) - Change From Baseline
Time frame: Study Day 1 and 43
Psoriasis Area Severity Index (PASI) - PASI Percentage Change - Including Subgroup Analysis AUC2h
Time frame: Study Day 1, 29 and 43
Psoriasis Area Severity Index (PASI) - PASI Percentage Change - Including Subgroup Analysis AUCt
Time frame: Study Day 1, 29 and 43
Psoriasis Area Severity Index (PASI) - PASI 30 and PASI 50 - Number of Patients
Time frame: Study Day 1, 29 and 43
Psoriasis Area Severity Index (PASI) - PASI 30 and PASI 50 - Responder Frequency
Time frame: Study Day 1, 29 and 43
Physician's Global Assessment (PGA) - Observed Values and Change From Baseline
Time frame: Study Day 1 and 43
Dermatology Life Quality Index (DLQI) - Observed Values and Change From Baseline.
Time frame: Study Day 1 and 43
EQ-5D 5L Visual Analogue Scale (VAS)
Time frame: Study Day 1 and 43
Modified Nail Psoriasis Severity Index (mNAPSI) - Observed Values and Change From Baseline
Time frame: Study Day 1 and 43
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- 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.
Anke Gauliard, MD principal investigator
Parexel
4 sites in 1 country: 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 and Plaque Psoriasis, run by MetrioPharm AG at 4 sites in Germany.
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 19 inclusion and 30 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 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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. 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 23 Jan 2019). 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?
Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs (time frame: Continuously from Treatment Start until the last follow-up visit on Study Day 71). The study lists 9 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 23 Jan 2019.