Trial · NCT07914231
A Study to Assess the Safety and Effectiveness of COL-5671-PRO Capsules in Adults With Moderate-to-Severe Plaque Psoriasis
NCT07914231, Phase 2, Not yet recruiting, Coultreon Biopharma
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study to Assess the Safety and Effectiveness of COL-5671-PRO Capsules in Adults With Moderate-to-Severe Plaque Psoriasis. Trials, record NCT07914231. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07914231
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Safety and Effectiveness of COL-5671-PRO Capsules in Adults With Moderate-to-Severe Plaque Psoriasis
- NCT number
- NCT07914231
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 100 participants, estimated
- Lead sponsor
- Coultreon Biopharma
- Conditions
- Plaque Psoriasis
- Interventions
- COL-5671-PRO, Placebo
- First posted
- 2026-11-03
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Reduction of 75% in PASI score relative to baseline (PASI75) at Week 12 | 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. |
| Secondary | Treatment-emergent adverse events (TEAEs), treatment emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation | From enrollment to the end of follow-up at 16 weeks | Number and percentage of participants with events per intervention arm, and total number of events by intervention arm. |
| Secondary | PASI score and percentage change from baseline in PASI score at Week 12 | 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. Descriptive statistics at Week 12 per intervention arm of the actual values and the percent changes from baseline. |
| Secondary | Reduction of 50/90/100% in PASI score relative to baseline at Week 12 | From enrollment till 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 50/90/100% in PASI score relative to baseline (PASI50/PASI90/PASI100) at Week 12 per intervention arm. |
| Secondary | PASI score ≤1 at Week 12 | From enrollment till 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 PASI score ≤1 at Week 12 per intervention arm. |
| Secondary | Percentage change from baseline in affected BSA at Week 12 | From enrollment till end of treatment at 12 weeks | 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. |
| Secondary | Change from baseline in sPGA score of plaque psoriasis at Week 12 | From enrollment till end of treatment at 12 weeks | 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. |
| Secondary | Change from baseline in PtGA score of plaque psoriasis at Week 12 | From enrollment till end of treatment at 12 weeks | 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. |
| Secondary | sPGA score of 0 (clear) or 1 (minimal disease) at Week 12 | From enrollment till end of treatment at 12 weeks | 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. |
| Secondary | sPGA score of 0 (clear) or 1 (minimal disease) and improvement of ≥2 points relative to baseline at Week 12 | From enrollment till end of treatment at 12 weeks | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07914231
GET https://conductscience.org/api/trials/v1/NCT07914231/registered