A Study to Assess the Safety and Effectiveness of COL-5671-PRO Capsules in Adults With Moderate-to-Severe Plaque Psoriasis

Trial details

Who runs it

Coultreon Biopharma

Trial code

NCT07914231EU 2026-527405-38-00

Record updated

3 November 2026

Original description

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 psoriasisRead full original descriptionShow less

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.

Inclusion: 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; 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.

Exclusion: Participant had a major surgery within 8 weeks prior to the first dose or has a major surgery planned during the trial; 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:; 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 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; 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 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; Candidate has non-plaque form of psoriasis (e.g. erythrodermic, guttate, or pustular psoriasis).

ClinicalTrials.gov NCT07914231 · EU CTIS 2026-527405-38-00