Plaque PsoriasisPhase 2NCT07914231
A Study to Assess the Safety and Effectiveness of COL-5671-PRO Capsules in Adults With Moderate-to-Severe Plaque Psoriasis
A Phase 2 study testing COL-5671-PRO in people with Plaque Psoriasis, run by Coultreon Biopharma at 6 sites in Canada.
Trial summary
The main purpose of this study is to assess how-well COL-5671-PRO works (clinical efficacy), how safe it is (safety), and how well it is tolerated (tolerability) when compared to placebo (a look-alike substance that contains no drug) in adults with moderate-to-severe plaque psoriasis Participants will take drug… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- COL-5671-PRO
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 6 sitesCanada
- Study dates
- 31 Oct 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Participant must be able and willing to comply with the clinical trial protocol requirements and must sign and date the informed consent form(s) as approved by the IEC/IRB prior to any screening evaluation and, if applicable, prior to participating in the optional skin biopsy subtrial.
- Diagnosed with plaque psoriasis, with stable psoriatic arthritis or without psoriatic arthritis, ≥6 months prior to screening.
- Participant has had stable plaque psoriasis ≥3 months before screening
- Screening and baseline PASI score ≥12 (moderate to severe) with affected BSA ≥10% and sPGA score ≥3.
- Candidate for phototherapy or systemic treatment for plaque psoriasis.
- Participant must have a Body Mass Index of ≥18 and ≤39 kg/m^2.
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- Participant must be able and willing to comply with restrictions on prior and concomitant medication.
- Participant must be able and willing to adhere to the lifestyle restrictions as described in the protocol.
- Participant with plaque psoriasis, that according to the investigator's judgement is not adequately controlled with his/her current therapy.
- Participant must be otherwise stable on the basis of medical history, physical examination, vital signs, and 12-lead Electrocardiogram (ECG) performed at screening.
Who cannot join
- Candidate has non-plaque form of psoriasis (e.g. erythrodermic, guttate, or pustular psoriasis).
- Candidate has current drug-induced psoriasis (e.g. a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium).
- Participant has a positive result for hepatitis B virus (HBV) (positive for hepatitis B surface antigen [HBsAg] or detectable hepatitis B virus core antibody (HBcAb]; participants having a negative HBsAg and a positive HBcAb result may enroll if they have a positive hepatitis B virus surface antibody [HBsAb] demonstrating natural immunity), or for hepatitis C virus (HCV) (positive for HCV antibody [Ab] and positive confirmatory polymerase chain reaction test for HCV; however, a participant with documented proof of cure from HCV may be enrolled).
- Participant has a history of human immunodeficiency virus (HIV) Ab positivity, or tests positive for HIV at screening.
- Participant has a history of or current immunosuppressive condition.
- Participant meets 1 of the following tuberculosis (TB) criteria at screening:
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- A history of active or currently active TB (regardless of treatment).
- A positive QuantiFERON®-TB Gold Plus In-tube test at screening unless the investigator assesses this is due to a documented history of adequately treated latent TB infection (LTBI).
- Participant has evidence of skin conditions other than psoriasis (e.g. eczema) at the time of screening or baseline visit that would interfere with the evaluation of psoriasis, per investigator judgement.
- Participant has a history or presence of clinically significant abnormalities detected on 12-lead ECG at screening or either rhythm or conduction, e.g. known long QT syndrome, or a QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 ms for male participants or >470 ms for female participants detected on the 12-lead ECG.
- Participant has a history of malignancy within the past 5 years prior to screening with the exception of excised and curatively treated non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin or in situ uterine cervical carcinoma which is considered cured with minimal risk of recurrence.
- Participant had a major surgery within 8 weeks prior to the first dose or has a major surgery planned during the trial.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Canada6 sites
Lynderm Research Inc.
Markham
DermEdge Cutting-edge Dermatology
Mississauga
SKiN Centre for Dermatology
Peterborough
Centre de Recherche Dermatologique due Quebec Metropolitain Inc.
Québec
The Centre for Dermatology
Richmond Hill
Skinsense Medical Research
Saskatoon
About this study
Official title: A Parallel-group, Phase 2, Randomized, Double-blind, Placebo-controlled, 4-arm, 12-week Trial to Investigate the Efficacy, Safety, and Tolerability of COL-5671-PRO Oral Capsules in Adult Participants With Moderate-to-Severe Plaque Psoriasis
The main purpose of this study is to assess how-well COL-5671-PRO works (clinical efficacy), how safe it is (safety), and how well it is tolerated (tolerability) when compared to placebo (a look-alike substance that contains no drug) in adults with moderate-to-severe plaque psoriasis
Participants will take drug COL-5671 or a placebo every day for 12 weeks.
- Conditions
- Plaque Psoriasis
- Being tested
- COL-5671-PRO, Placebo
- Keywords
- Psoriasis, COL-5671, COL-5671-PRO, O3R-5671, O3R-5671-PRO, GLPG5671
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COL-5671-PRODrug
COL-5671-PRO oral capsules
PlaceboDrug
Matching placebo to COL-5671-PRO capsules
| Study group | Role | What they receive |
|---|---|---|
| COL-5671-PRO Treatment A | Experimental | Participant will receive dose A of COL-5671-PRO capsules orally once daily (QD) for 12 weeks. Receives: Drug: COL-5671-PRO |
| COL-5671-PRO Treatment B | Experimental | Participant will receive dose B of COL-5671-PRO capsules orally once daily (QD) for 12 weeks. Receives: Drug: COL-5671-PRO |
| COL-5671-PRO Treatment C | Experimental | Participant will receive dose C of COL-5671-PRO capsules orally once daily (QD) for 12 weeks. Receives: Drug: COL-5671-PRO |
| Placebo | Placebo comparator | Participant will receive placebo to match COL-5671-PRO capsules orally once daily (QD) for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of 75% in PASI score relative to baseline (PASI75) at Week 12
The Psoriasis Area and Severity Index (PASI) combines assessments of the extent of body-surface involvement in 4 anatomical regions (head and neck, upper limbs, trunk, lower limbs) and the severity of erythema, induration, and desquamation in each region, yielding an overall score of 0 to 72. A frequency table of participants with a reduction of 75% in PASI score relative to baseline (PASI75) at Week 12 per intervention arm.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (10)
Treatment-emergent adverse events (TEAEs), treatment emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation
Number and percentage of participants with events per intervention arm, and total number of events by intervention arm.
Measured: From enrollment to the end of follow-up at 16 weeks
PASI score and percentage change from baseline in PASI score at Week 12
The Psoriasis Area and Severity Index (PASI) combines assessments of the extent of body-surface involvement in 4 anatomical regions (head and neck, upper limbs, trunk, lower limbs) and the severity of erythema, induration, and desquamation in each region, yielding an overall score of 0 to 72. Descriptive statistics at Week 12 per intervention arm of the actual values and the percent changes from baseline.
Measured: From enrollment to the end of treatment at 12 weeks
Reduction of 50/90/100% in PASI score relative to baseline at Week 12
The Psoriasis Area and Severity Index (PASI) combines assessments of the extent of body-surface involvement in 4 anatomical regions (head and neck, upper limbs, trunk, lower limbs) and the severity of erythema, induration, and desquamation in each region, yielding an overall score of 0 to 72. A frequency table of participants with a reduction of 50/90/100% in PASI score relative to baseline (PASI50/PASI90/PASI100) at Week 12 per intervention arm.
Measured: From enrollment till end of treatment at 12 weeks
PASI score ≤1 at Week 12
The Psoriasis Area and Severity Index (PASI) combines assessments of the extent of body-surface involvement in 4 anatomical regions (head and neck, upper limbs, trunk, lower limbs) and the severity of erythema, induration, and desquamation in each region, yielding an overall score of 0 to 72. A frequency table of participants with a PASI score ≤1 at Week 12 per intervention arm.
Measured: From enrollment till end of treatment at 12 weeks
Percentage change from baseline in affected BSA at Week 12
The percentage of surface area of the body (BSA) involved with plaque psoriasis. The handprint method for assessing BSA will be used, where the surface area of the participant's hand, including the palm and all 5 digits, is used as a guide to estimate 1% BSA. Descriptive statistics at Week 12 per intervention arm of percent changes from baseline.
Measured: From enrollment till end of treatment at 12 weeks
Change from baseline in sPGA score of plaque psoriasis at Week 12
A global assessment of psoriasis disease activity performed by the physician (sPGA). The sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. The participant's psoriasis disease activity will be assessed by a physician for the 3 primary signs of psoriasis (induration, erythema, and scaling), scored as clear (0), almost clear (1), mild (2), moderate (3), and severe (4). Descriptive statistics at Week 12 per intervention arm of changes from baseline.
Measured: From enrollment till end of treatment at 12 weeks
Change from baseline in PtGA score of plaque psoriasis at Week 12
A global assessment of psoriasis disease activity performed by the participant (PtGA). The PtGA of psoriasis is a single-item, patient-completed assessment that is used to evaluate the overall extent of psoriasis-related cutaneous disease at a particular point in time using an 11-point Numerical Rating Scale (NRS), answering the question "On a scale from 0 to 10, with 0 being 'not at all' and 10 being 'very severe', how would you rate the severity of your PsO at this moment? Descriptive statistics at Week 12 per intervention arm of changes from baseline.
Measured: From enrollment till end of treatment at 12 weeks
sPGA score of 0 (clear) or 1 (minimal disease) at Week 12
A global assessment of psoriasis disease activity performed by the physician (sPGA). The sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. The participant's psoriasis disease activity will be assessed by a physician for the 3 primary signs of psoriasis (induration, erythema, and scaling), scored as clear (0), almost clear (1), mild (2), moderate (3), and severe (4). A frequency table of participants with a sPGA score of 0 or 1 at Week 12 per intervention arm.
Measured: From enrollment till end of treatment at 12 weeks
sPGA score of 0 (clear) or 1 (minimal disease) and improvement of ≥2 points relative to baseline at Week 12
A global assessment of psoriasis disease activity performed by the physician (sPGA). The sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. The participant's psoriasis disease activity will be assessed by a physician for the 3 primary signs of psoriasis (induration, erythema, and scaling), scored as clear (0), almost clear (1), mild (2), moderate (3), and severe (4). A frequency table of participants with a sPGA score of 0 or 1 and an improvement of ≥2 points relative to baseline at Week 12 per intervention arm.
Measured: From enrollment till end of treatment at 12 weeks
sPGA score of 0 at Week 12
A global assessment of psoriasis disease activity performed by the physician (sPGA). The sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. The participant's psoriasis disease activity will be assessed by a physician for the 3 primary signs of psoriasis (induration, erythema, and scaling), scored as clear (0), almost clear (1), mild (2), moderate (3), and severe (4). A frequency table of participants with a sPGA score of 0 at Week 12 per intervention arm.
Measured: From enrollment till end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start31 Oct 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coultreon Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914231
- Sponsor's protocol ID
- COL-5671-CL-201
- Other IDs
- 2026-527405-38-00
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel-group, Phase 2, Randomized, Double-blind, Placebo-controlled, 4-arm, 12-week Trial to Investigate the Efficacy, Safety, and Tolerability of COL-5671-PRO Oral Capsules in Adult Participants With Moderate-to-Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT07914231
- Acronym / sponsor ID
- COL-5671-CL-201
- Conditions
- Plaque Psoriasis
- Keywords
- Psoriasis, COL-5671, COL-5671-PRO, O3R-5671, O3R-5671-PRO, GLPG5671
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Coultreon BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to assess how-well COL-5671-PRO works (clinical efficacy), how safe it is (safety), and how well it is tolerated (tolerability) when compared to placebo (a look-alike substance that contains no drug) in adults with moderate-to-severe plaque psoriasis
Participants will take drug COL-5671 or a placebo every day for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| COL-5671-PRO Treatment A | Experimental | Drug: COL-5671-PROParticipant will receive dose A of COL-5671-PRO capsules orally once daily (QD) for 12 weeks. |
| COL-5671-PRO Treatment B | Experimental | Drug: COL-5671-PROParticipant will receive dose B of COL-5671-PRO capsules orally once daily (QD) for 12 weeks. |
| COL-5671-PRO Treatment C | Experimental | Drug: COL-5671-PROParticipant will receive dose C of COL-5671-PRO capsules orally once daily (QD) for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipant will receive placebo to match COL-5671-PRO capsules orally once daily (QD) for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participant must be able and willing to comply with the clinical trial protocol requirements and must sign and date the informed consent form(s) as approved by the IEC/IRB prior to any screening evaluation and, if applicable, prior to participating in the optional skin biopsy subtrial.
- Diagnosed with plaque psoriasis, with stable psoriatic arthritis or without psoriatic arthritis, ≥6 months prior to screening.
- Participant has had stable plaque psoriasis ≥3 months before screening
- Screening and baseline PASI score ≥12 (moderate to severe) with affected BSA ≥10% and sPGA score ≥3.
- Candidate for phototherapy or systemic treatment for plaque psoriasis.
Key exclusion criteria (12 listed)
- Candidate has non-plaque form of psoriasis (e.g. erythrodermic, guttate, or pustular psoriasis).
- Candidate has current drug-induced psoriasis (e.g. a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium).
- Participant has a positive result for hepatitis B virus (HBV) (positive for hepatitis B surface antigen [HBsAg] or detectable hepatitis B virus core antibody (HBcAb]; participants having a negative HBsAg and a positive HBcAb result may enroll if they have a positive hepatitis B virus surface antibody [HBsAb] demonstrating natural immunity), or for hepatitis C virus (HCV) (positive for HCV antibody [Ab] and positive confirmatory polymerase chain reaction test for HCV; however, a participant with documented proof of cure from HCV may be enrolled).
- Participant has a history of human immunodeficiency virus (HIV) Ab positivity, or tests positive for HIV at screening.
- Participant has a history of or current immunosuppressive condition.
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 |
|---|---|---|
| COL-5671-PROCOL-5671-PRO oral capsules | Drug | COL-5671-PRO Treatment A, COL-5671-PRO Treatment B, COL-5671-PRO Treatment C |
| PlaceboMatching placebo to COL-5671-PRO capsules | Drug | Placebo |
Primary outcome
Reduction of 75% in PASI score relative to baseline (PASI75) at Week 12
Time frame: From enrollment to the end of treatment at 12 weeks
The Psoriasis Area and Severity Index (PASI) combines assessments of the extent of body-surface involvement in 4 anatomical regions (head and neck, upper limbs, trunk, lower limbs) and the severity of erythema, induration, and desquamation in each region, yielding an overall score of 0 to 72. A frequency table of participants with a reduction of 75% in PASI score relative to baseline (PASI75) at Week 12 per intervention arm.
10 secondary outcomes
Treatment-emergent adverse events (TEAEs), treatment emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation
Time frame: From enrollment to the end of follow-up at 16 weeks
PASI score and percentage change from baseline in PASI score at Week 12
Time frame: From enrollment to the end of treatment at 12 weeks
Reduction of 50/90/100% in PASI score relative to baseline at Week 12
Time frame: From enrollment till end of treatment at 12 weeks
PASI score ≤1 at Week 12
Time frame: From enrollment till end of treatment at 12 weeks
Percentage change from baseline in affected BSA at Week 12
Time frame: From enrollment till end of treatment at 12 weeks
Change from baseline in sPGA score of plaque psoriasis at Week 12
Time frame: From enrollment till end of treatment at 12 weeks
Change from baseline in PtGA score of plaque psoriasis at Week 12
Time frame: From enrollment till end of treatment at 12 weeks
sPGA score of 0 (clear) or 1 (minimal disease) at Week 12
Time frame: From enrollment till end of treatment at 12 weeks
sPGA score of 0 (clear) or 1 (minimal disease) and improvement of ≥2 points relative to baseline at Week 12
Time frame: From enrollment till end of treatment at 12 weeks
sPGA score of 0 at Week 12
Time frame: From enrollment till end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- 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.
6 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 COL-5671-PRO in people with Plaque Psoriasis, run by Coultreon Biopharma at 6 sites in Canada.
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 10 inclusion and 12 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helen Timmis (+32 (0)16 98 25 81, clinical@coultreon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of 75% in PASI score relative to baseline (PASI75) at Week 12 (time frame: From enrollment to the end of treatment at 12 weeks). 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 3 Nov 2026.