NCT02931838|CompletedPhase 2ResultsDMCFDA Drug

Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate the Clinical Efficacy and Safety of BMS-986165 in Subjects With Moderate to Severe Psoriasis

Bristol-Myers Squibb ClinicalTrials.gov

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1 other identifier

IM011-011

Study Type

interventional

Target

268

Locations

8 countries

Sites

Timeline

RegisteredOct 2016

StartedNov 2016

CompletionNov 2017

Brief Summary

A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis treated with BMS-986165

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

268

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Nov 2016

Shorter than P25 for phase_2

Geographic Reach

8 countries

76 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1 year study duration

First Submitted

Initial submission to the registry

October 3, 2016

Completed

10 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed

1 month until next milestone

Study Start

First participant enrolled

November 15, 2016

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2017

Completed

3 years until next milestone

Results Posted

Study results publicly available

November 27, 2020

Completed

Last Updated

November 27, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

October 3, 2016

Results QC Date

October 30, 2020

Last Update Submit

October 30, 2020

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (2)

The Percentage of Participants With Moderate to Severe Psoriasis Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Day 85 (Week 12)
Psoriasis Area and Severity Index (PASI) 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretical maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.
Day 1 to Day 85
Number of Participants With Adverse Events
The safety and tolerability of BMS-986195 as assessed by the number of subjects with adverse events (AEs); number of subjects with serious adverse events (SAEs); number of subjects with adverse events leading to discontinuation
Day 1 to day 115

Secondary Outcomes (5)

Percentage of Participants on Day 85 With PASI-50, PASI-90, PASI-100.
Day 1 to Day 85
Percentage of Participants on Day 85 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate).
Day 1 to Day 85
Change From Baseline in DLQI Scores on Day 85
Day 1 to Day 85
Change From Baseline in BSA on Day 85
Day 1 to Day 85
Trough Observed Plasma Concentration of BMS-986165 (Ctrough)
Days 8, 15, 29, 57, 85