Phase 2
N=267
Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT02931838 ↗Enrolled (actual)
267
Serious AEs
1.5%
Results posted
Nov 2020
Primary outcome: Primary: 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) — 6.7; 9.1; 38.6; 68.9 Percentage — p=0.4873
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BMS-986165 (Drug); Placebo for BMS-986165 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
6.7; 9.1; 38.6; 68.9; 66.7; 75.0 | 0.4873 |
| PRIMARY Number of Participants With Adverse Events |
1; 1; 1; 1; 0; 0 | — |
| SECONDARY Percentage of Participants on Day 85 With PASI-50, PASI-90, PASI-100. |
31.1; 43.2; 68.2; 91.1; 77.8; 88.6 | — |
| SECONDARY Percentage of Participants on Day 85 With sPGA Score of 0 or 1 (sPGA0/1 Response Rate). |
6.7; 20.5; 38.6; 75.6; 64.4; 75.0 | — |
| SECONDARY Change From Baseline in DLQI Scores on Day 85 |
-2.85; -3.76; -6.07; -9.67; -8.38; -10.16 | — |
| SECONDARY Change From Baseline in BSA on Day 85 |
-7.71; -5.50; -12.59; -18.60; -17.23; -15.16 | — |
| SECONDARY Trough Observed Plasma Concentration of BMS-986165 (Ctrough) |
2.024; 3.145; 14.819; 26.257; 17.824 | — |
Summary
A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis treated with BMS-986165
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Male and female, ages 18 to 70 years
- Diagnosis of plaque psoriasis for 6 months
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test, must not be pregnant, lactating, breastfeeding or planning pregnancy
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment plus 5 half-lives of the study drug plus 90 days.
Exclusion Criteria
- Any significant acute or chronic medical illness
- Blood transfusion within 4 weeks of study drug administration
- Inability to tolerate oral medication
- Positive hepatitis-B (HBV) surface antigen
- Positive hepatitis-C (HCV) antibody
- Any history or risk for tuberculosis (TB)
- Any major illness/condition or evidence of an unstable clinical condition
- Chest X-ray findings suspicious of infection at screening
- has received ustekinumab, secukinumab or ixekizumab within 6 months of first administration of study medication
- Has received anti-Tumor Necrosis Factor (TNF) inhibitor(s) within 2 months of first administration of study medication
- Has received Rituximab within 6 months of first administration of study medication
- Topical medications/treatments for psoriasis within 2 weeks of the first administration of any study medication
- Any systemic medications/treatments for psoriasis within 4 weeks of the first administration of any study medication
Other protocol defined inclusion/exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT02931838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.