Psoriasis VulgarisPhase 2NCT03614078
A Study of PRCL-02 in Moderate to Severe Chronic Plaque Psoriasis
A Phase 2 study testing PRCL-02 in people with Psoriasis Vulgaris and Plaque Psoriasis, run by PRCL Research Inc. at 16 sites in 3 countries.
Trial summary
The aim of this study is to evaluate safety, tolerability, and efficacy of PRCL-02 in moderate to severe chronic plaque psoriasis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis Vulgaris, Plaque Psoriasis
- What is being tested?
- PRCL-02
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 25 Sep 2018to 8 Jul 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presents with moderate to severe psoriasis vulgaris based on:
- Chronic psoriasis vulgaris for at least 6 months
- Plaque psoriasis involving at least 10% body surface area (BSA)
- Psoriasis Area and Severity Index (PASI) total score of at least 12
- Have at least 2 evaluable plaques located in 2 different body regions. (Also for participants who elect to have plaques biopsied, should be suitable for a total of 4 punch biopsies each, and one lesion, preferably on a region of the body that is not normally exposed (e.g., trunk), should be selected for biopsy)
- Have a Static Physician's Global Assessment (sPGA) score of greater than or equal to (≥)3
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- Are candidates for systemic therapy
- Have a body mass index (BMI) within the range of 18 to 40 kilograms per square meter (kg/m2)
- Women who are of childbearing potential must agree to use 1 highly effective method of contraception, or a combination of 2 effective methods of contraception for the entirety of the study
- Women of non childbearing potential are defined as women who are:
- Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis; or
- Post-menopausal, defined as either:
- A woman at least 50 years of age with an intact uterus, not on hormone therapy, who has had either: cessation of menses for at least 1 year; or at least 6 months of spontaneous amenorrhea with a follicle stimulating hormone greater than (>)40 milli-international units per milliliter (mIU/mL); or
- A woman 55 years or older not on hormone therapy, who has had at least 6 months of spontaneous amenorrhea; or
- A woman at least 55 years of age with a diagnosis of menopause prior to staring hormone replacement therapy
Who cannot join
- Currently enrolled in any other clinical trial involving a study drug or device, or any other type of medical research judged not compatible with this study (Participants in the previous PRCL study (SMAD) will be allowed to be included in this study, provided that they meet all inclusion and none of the exclusion criteria)
- Participated in a clinical study within last 30 days
- Present with pustular, erythrodermic psoriasis, generalized pustular psoriasis, or acute guttate psoriasis
- Have current serious or unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including a history of ischemic or structural heart disease, conduction system disease or history of clinically significant arrhythmia), endocrinologic, neurologic, psychiatric, immunologic, hematologic, or dermatologic disease
- Have a history of clinically significant severe drug allergies or severe post treatment hypersensitivity reactions
- Have received inactivated vaccine within 4 weeks prior to dosing in this study, or a live vaccine within the last 3 months
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- A history of clinically significant opportunistic infection (for example, invasive candidiasis or Pneumocystis pneumonia)
- Had symptomatic herpes zoster within last 3 months or other recent or ongoing infection
- Present with any of the following laboratory test results:
- Positive QuantiFERON®-tuberculosis test
- For women, positive serum pregnancy test
- Evidence of Human Immunodeficiency Virus (HIV) infection or are positive for HIV antibodies
- Positive test for active hepatitis B
- Positive of anti-hepatitis C antibody with confirmed presence of hepatitis C virus, or chronic liver disease
- Evidence of clinically significant hepatic or renal impairment
- Clinically significant ECG (electrocardiogram) abnormalities or personal or family history of heart disease, including:
- Confirmed corrected QT interval with Frederica's correction (QTcF) >450 milliseconds (msec) for both men and women
- Specific bundle branch blocks, irregular rhythms, history of unexplained syncope, or family history of unexplained death
- Are receiving any of the following therapies for psoriasis:
- Systemic retinoids within last 12 weeks
- Systemic psoriasis therapy, such as psoralen and ultraviolet A (PUVA) light therapy, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, azathioprine, or phototherapy (including ultraviolet B or self-treatment with tanning beds or therapeutic sunbathing) within last 4 weeks
- Topical psoriasis treatment within last 2 weeks; or
- Any biologic agent within the following washout periods: 30 days for anti-tumor necrosis factor (TNF) inhibitors, and 90 days for other agents
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
Canada7 sites
SimcoDerm Medical and Surgical Dermatology
Barrie, Ontario, L4M 7G1
DermEffects
London, Ontario, N6H5L5
Lynderm Research Inc.
Markham, Ontario, L3P1X2
SKiN Centre for Dermatology
Peterborough, Ontario, K9J5K2
K. Papp Clinical Research
Waterloo, Ontario, N2J1C4
Carey-Wang - Dermatology & Dermatologic Surgery Center
Westmount, Quebec, H3Z2S6
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M3Z4
Slovakia6 sites
Maxderm Dermatovenerologická ambulancia
Bardejov, 085 01
SKINKLINIK Dermatovenerologická ambulancia
Bratislava, 831 03
BeneDerma
Bratislava, 841 02
Derma therapy, spol.
Bratislava, 851 01
AHS Dermatology
Nitra, 949 01
SANARE - Dermatovenerologická ambulancia
Svidník, 089 01
Ukraine3 sites
Oleksandrivska Clinical Hospital, Department of Dermatology and Venereology
Kiev, 01601
LLC MK BLAGOMED, Department of Dermatology
Kyiv, 04050
Zaporizhzhya Regional Dermatovenereology Clinical Hospital
Zaporizhzhya, 69063
About this study
Official title: A Phase 2a Study to Evaluate Safety, Tolerability, and Efficacy of PRCL-02 in Patients With Moderate to Severe Chronic Plaque Psoriasis
The aim of this study is to evaluate safety, tolerability, and efficacy of PRCL-02 in moderate to severe chronic plaque psoriasis
- Conditions
- Psoriasis Vulgaris, Plaque Psoriasis
- Being tested
- PRCL-02, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRCL-02Drug
Oral tablets
PlaceboDrug
Oral tablets
| Study group | Role | What they receive |
|---|---|---|
| PRCL-02 Dose 1 | Experimental | Loading dose followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks Receives: Drug: PRCL-02 |
| PRCL-02 Dose 2 | Experimental | Loading dose followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks Receives: Drug: PRCL-02 |
| Placebo | Placebo comparator | Loading dose followed by a once daily maintenance dose at matching treatment levels, commencing on Day 2 and continuing for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement
Following 12 weeks of treatment. The Psoriasis Area and Severity Index (PASI) scores the severity of disease on a scale from 0 to 72 (where a score of 72 indicates extreme disease severity). PASI 75 indicates 75% improvement from baseline to Week 12 in the Psoriasis Area and Severity Index
Measured: Baseline to week 12
Secondary outcomes (4)
Number of Participants With Any Treatment Emergent Adverse Event
Following 12 weeks of treatment
Measured: Baseline up to week 18
Area Under the Concentration Time Curve (AUC0-τ)
Steady state after 12 weeks of treatment
Measured: Predose and 1, 2, 4, 8, 336, 672, 1008, 1344 hours post dose, on Day 84
Maximum Observed Drug Concentration (Cmax)
Steady state after 12 weeks of treatment
Measured: Predose and 1, 2, 4, 8, 336, 672, 1008, 1344 hours post dose, on Day 84
Time to Reach Maximum Observed Drug Concentration (Tmax)
Steady state after 12 weeks of treatment
Measured: Predose and 1, 2, 4, 8, 336, 672, 1008, 1344 hours post dose, on Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start25 Sep 2018
- Primary completion29 Apr 2019
- Study completion8 Jul 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 Psoriasis VulgarisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- PRCL Research Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, PRCL Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614078
- Sponsor's protocol ID
- PRCL-PoC
- Status last verified
- Mar 2020
- First submitted
- 30 Jul 2018
- Last updated
- 30 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Study to Evaluate Safety, Tolerability, and Efficacy of PRCL-02 in Patients With Moderate to Severe Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT03614078
- Acronym / sponsor ID
- PRCL-PoC
- Conditions
- Psoriasis Vulgaris, Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- PRCL Research Inc.University, hospital or other
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 29 Apr 2019 (actual)
- Study completion
- 8 Jul 2019 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Posted 30 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate safety, tolerability, and efficacy of PRCL-02 in moderate to severe chronic plaque psoriasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PRCL-02 Dose 1 | Experimental | Drug: PRCL-02Loading dose followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks |
| PRCL-02 Dose 2 | Experimental | Drug: PRCL-02Loading dose followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboLoading dose followed by a once daily maintenance dose at matching treatment levels, commencing on Day 2 and continuing for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Presents with moderate to severe psoriasis vulgaris based on:
- Have at least 2 evaluable plaques located in 2 different body regions. (Also for participants who elect to have plaques biopsied, should be suitable for a total of 4 punch biopsies each, and one lesion, preferably on a region of the body that is not normally exposed (e.g., trunk), should be selected for biopsy)
- Have a Static Physician's Global Assessment (sPGA) score of greater than or equal to (≥)3
- Are candidates for systemic therapy
- Have a body mass index (BMI) within the range of 18 to 40 kilograms per square meter (kg/m2)
Key exclusion criteria (23 listed)
- Currently enrolled in any other clinical trial involving a study drug or device, or any other type of medical research judged not compatible with this study (Participants in the previous PRCL study (SMAD) will be allowed to be included in this study, provided that they meet all inclusion and none of the exclusion criteria)
- Participated in a clinical study within last 30 days
- Present with pustular, erythrodermic psoriasis, generalized pustular psoriasis, or acute guttate psoriasis
- Have current serious or unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including a history of ischemic or structural heart disease, conduction system disease or history of clinically significant arrhythmia), endocrinologic, neurologic, psychiatric, immunologic, hematologic, or dermatologic disease
- Have a history of clinically significant severe drug allergies or severe post treatment hypersensitivity reactions
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 |
|---|---|---|
| PRCL-02Oral tablets | Drug | PRCL-02 Dose 1, PRCL-02 Dose 2 |
| PlaceboOral tablets | Drug | Placebo |
Primary outcome
Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement
Time frame: Baseline to week 12
Following 12 weeks of treatment. The Psoriasis Area and Severity Index (PASI) scores the severity of disease on a scale from 0 to 72 (where a score of 72 indicates extreme disease severity). PASI 75 indicates 75% improvement from baseline to Week 12 in the Psoriasis Area and Severity Index
4 secondary outcomes
Number of Participants With Any Treatment Emergent Adverse Event
Time frame: Baseline up to week 18
Area Under the Concentration Time Curve (AUC0-τ)
Time frame: Predose and 1, 2, 4, 8, 336, 672, 1008, 1344 hours post dose, on Day 84
Maximum Observed Drug Concentration (Cmax)
Time frame: Predose and 1, 2, 4, 8, 336, 672, 1008, 1344 hours post dose, on Day 84
Time to Reach Maximum Observed Drug Concentration (Tmax)
Time frame: Predose and 1, 2, 4, 8, 336, 672, 1008, 1344 hours post dose, on Day 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Study Director study director
PRCL Research Inc.
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRCL-02 in people with Psoriasis Vulgaris and Plaque Psoriasis, run by PRCL Research Inc. at 16 sites in 3 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 15 inclusion and 23 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 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Canada, Slovakia, Ukraine. 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 30 Mar 2020). 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?
Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (time frame: Baseline to week 12). 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 30 Mar 2020.