Phase 2
Completed N=109
A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis
Psoriasis
Source: ClinicalTrials.gov NCT05730725 ↗
Enrolled (actual)
109
Serious AEs
1.8%
Results posted
Nov 2025
Primary outcomePrimary: Percentage of Participants Achiving PASI-75 at Week 12 — 3.6; 47.8; 80.8; 63.0 Percentage
Summary
The purpose of this study is to evaluate clinical effectiveness and safety of BMS-986322 in participants with moderate-to-severe psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achiving PASI-75 at Week 12 |
3.6; 47.8; 80.8; 63.0 | — |
| PRIMARY Number of Participants With Safety Related Events |
16; 14; 14; 16; 1; 1 | — |
| PRIMARY Number of Participants With TEAE by Worst Intensity |
10; 7; 10; 10; 6; 7 | — |
| PRIMARY Number of Participants With AE Indicating Clinical Laboratory Abnormality |
0; 0; 1; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes From Baseline in ECG Evaluations. |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Evaluations |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Evaluations |
0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Achiving sPGA Score of 0 or 1 at Week 12 |
3.6; 54.2; 69.2; 55.6 | — |
| SECONDARY Percentage of Participants Achiving PASI-50 at Week 12 |
17.9; 73.9; 92.3; 81.5 | — |
| SECONDARY Percentage of Participants Achiving PASI-90 at Week 12 |
3.6; 13.0; 61.5; 40.7 | — |
| SECONDARY Percentage of Participants Achiving PASI-100 at Week 12 |
0; 0; 15.4; 3.7 | — |
| SECONDARY Change of PASI-75 Scores Overtime |
0.0; 0.0; 0.0; 3.8; 0.0; 0.0 | — |
| SECONDARY Change of PASI-90 Scores Overtime |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Change of PASI-100 Scores Overtime |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Change of PASI-50 Scores Overtime |
0.0; 3.8; 7.7; 7.7; 12.0; 14.8 | — |
| SECONDARY Mean Change Frome Baseline of PASI Scores Overtime |
-0.50; -2.85; -2.95; -3.36; -3.30; -5.16 | — |
| SECONDARY Ctrough Measurements Overtime |
55.463; 128.971; 138.950; 57.595; 99.871; 191.509 | — |
| SECONDARY Cmax at Day 15 |
210.410; 411.027; 871.064 | — |
| SECONDARY Tmax at Day 15 |
1.0830; 1.0415; 2.000 | — |
| SECONDARY AUC(Tau) at Day 15 |
2576.824; 5057.790; 11815.731 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of plaque psoriasis (PsO) for ≥ 6 months
- Body mass index 18 to 40 kg/m^2 and total body weight > 50 kg (110 lbs)
- Deemed by Investigator to be eligible for phototherapy or systemic therapy
- Psoriatic plaques must cover ≥ 10% of body surface area at baseline
- Psoriasis Area and Severity Index (PASI) score ≥ 12 and static Physician Global Assessment (sPGA) ≥ 3 at baseline
Exclusion Criteria
- Diagnosis of non-plaque psoriasis (guttate, inverse, pustular, erythrodermic)
- Diagnosis of uveitis, inflammatory bowel disease, or other immune-mediated conditions that are commonly associated with PsO for which a participant requires current systemic immunosuppressant medical treatment
- Any significant acute or chronic medical illness
Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT05730725). 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.