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COL-5671-PRO for Plaque Psoriasis

Not yet recruiting at 5 trial locations
HT
Overseen ByHelen Timmis
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Coultreon Biopharma
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults with moderate-to-severe plaque psoriasis, including those with palmoplantar pustulosis. Participants should be generally healthy aside from their skin condition and meet specific medical criteria set by the study.

Inclusion Criteria

Screening and baseline PASI score ≥12 (moderate to severe) with affected BSA ≥10% and sPGA score ≥3
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
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Exclusion Criteria

Participant has a history of or current immunosuppressive condition
Participant has a positive result for hepatitis B virus (HBV) (positive for HBsAg or detectable HBcAb; negative HBsAg and positive HBcAb allowed if positive HBsAb demonstrating natural immunity) or hepatitis C virus (HCV) (positive HCV antibody and confirmatory PCR test; documented proof of cure allowed)
Participant has clinically significant abnormalities on 12-lead ECG at screening including known long QT syndrome or QTcF >450 ms for males or >470 ms for females
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What Are the Treatments Tested in This Trial?

Interventions

  • COL-5671-PRO

Trial Overview

The study compares a new capsule medication called COL-5671-PRO to a placebo (a pill with no active drug). Participants are randomly assigned to take either the real drug or placebo daily for 12 weeks.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: COL-5671-PRO Treatment CExperimental Treatment1 Intervention
Group II: COL-5671-PRO Treatment BExperimental Treatment1 Intervention
Group III: COL-5671-PRO Treatment AExperimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Coultreon Biopharma

Lead Sponsor

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