Phase 3
Completed N=1,020
An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis
Psoriasis
Source: ClinicalTrials.gov NCT03611751 ↗
Enrolled (actual)
1,020
Serious AEs
1.7%
Results posted
Dec 2022
Primary outcomePrimary: The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1) — 253; 22 Participants — p=<0.0001
◆ Published Evidence
Established
38citations · ~38 / year
Safety and Efficacy of Deucravacitinib in Moderate to Severe Plaque Psoriasis for Up to 3 Years: An Open-Label Extension of Randomized Clinical Trials.
Summary
The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo and a currently available treatment in participants with moderate to severe plaque psoriasis.
Linked Publications (5)
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Safety and Efficacy of Deucravacitinib in Moderate to Severe Plaque Psoriasis for Up to 3 Years: An Open-Label Extension of Randomized Clinical Trials.
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Deucravacitinib Improves Patient-Reported Outcomes in Patients with Moderate to Severe Psoriasis: Results from the Phase 3 Randomized POETYK PSO-1 and PSO-2 Trials.
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Deucravacitinib in Patients with Plaque Psoriasis Who Screened Positive for Psoriatic Arthritis: Improvements in Joint Pain and the Impact of Musculoskeletal Symptoms.
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Deucravacitinib: Laboratory Parameters Across Phase 3 Plaque Psoriasis Trials.
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Deucravacitinib in Plaque Psoriasis After Inadequate Response to Apremilast: Phase 3 POETYK Analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1) |
253; 22 | <0.0001 sig |
| PRIMARY The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75) |
271; 24 | <0.0001 sig |
| SECONDARY The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 90) |
138; 7; 46 | <0.0001 sig |
| SECONDARY The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 100) |
52; 3; 11 | <0.001 sig |
| SECONDARY The Number of Participants With a Static Physician Global Assessment Score of 0 at Week 16 (sPGA 0) |
80; 3; 16 | <0.0001 sig |
| SECONDARY Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score at Week 16 |
-28.9; -4.2; -21.5 | <0.0001 sig |
| SECONDARY Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Week 16 |
35; 3; 10 | 0.0005 sig |
| SECONDARY The Number of Participants With a Scalp Specific Physician's Global Assessment (Ss-PGA) Score 0 or 1 at Week 16 (Ss-PGA 0/1) |
182; 30; 61 | <0.0001 sig |
| SECONDARY The Number of Participants With a Dermatology Life Quality Index (DLQI) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (DLQI 0/1) |
186; 24 | <0.0001 sig |
| SECONDARY The Number of Participants With a Physician Global Assessment- Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PGA-F 0/1) |
14; 3 | 0.0621 |
| SECONDARY The Number of Participants With a Palmoplantar Physician's Global Assessment (Pp-PGA) Score of 0 or 1 at Week 16 (Pp-PGA 0/1) |
18; 4; 8 | 0.6692 |
| SECONDARY The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (PASI 75) |
271; 101 | 0.0004 sig |
| SECONDARY The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (sPGA 0/1) |
253; 86 | <0.0001 sig |
| SECONDARY Time to Relapse Until Week 52 Among Week 24 PASI 75 Responders |
NA; NA; 197.0 | <0.0001 sig |
| SECONDARY The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (sPGA 0/1) |
251; 75 | <0.0001 sig |
| SECONDARY The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (PASI 75) |
296; 96 | <0.0001 sig |
| SECONDARY The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 90) |
164; 50 | 0.0001 sig |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Plaque psoriasis for at least 6 months
- Moderate to severe disease
- Candidate for phototherapy or systemic therapy
Exclusion Criteria
- Other forms of psoriasis
- History of recent infection
- Prior exposure to BMS-986165 or active comparator
Other protocol defined inclusion/exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT03611751) and the linked publication. 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. Informational only — not medical advice.