Phase 2
Completed N=203
Efficacy and Safety of BMS-986165 Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA)
Active Psoriatic Arthritis
Source: ClinicalTrials.gov NCT03881059 ↗
Enrolled (actual)
203
Serious AEs
4.9%
Results posted
May 2021
Primary outcomePrimary: Percentage of Participants Achieving the American College of Rheumatology (ACR) 20 Response at Week 16 — 31.8; 52.9; 62.7 Percent of Participants — p=<0.001
Summary
The main purpose of study is to assess the dose-response relationship of BMS-986165 (Dose A or Dose B once daily [QD]) at Week 16 in the treatment of participants with active PsA.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving the American College of Rheumatology (ACR) 20 Response at Week 16 |
31.8; 52.9; 62.7 | <0.001 sig |
| SECONDARY Adjusted Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) |
-0.11; -0.37; -0.39 | — |
| SECONDARY Percentage of Participants Achieving the Psoriasis Area and Severity Index (PASI) 75 Response |
20.4; 42.4; 59.6 | — |
| SECONDARY Adjusted Change From Baseline in the Physical Component Summary (PCS) Score of the Short Form Health Survey-36 (SF-36) Questionnaire |
2.3; 5.6; 5.8 | — |
| SECONDARY Percentage of Participants Achieving the American College of Rheumatology (ACR) 50 Response at Week 16 |
10.6; 24.3; 32.8 | — |
| SECONDARY Percentage of Participants Achieving the American College of Rheumatology (ACR) 70 Response at Week 16 |
1.5; 14.3; 19.4 | — |
| SECONDARY Percentage of Participants Achieving Low Disease Activity According to the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP) |
22.7; 37.1; 43.3 | — |
| SECONDARY Percentage of Participants Achieving Remission According to the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP) |
6.1; 24.3; 25.4 | — |
| SECONDARY Adjusted Change From Baseline in the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP) Score |
-0.9; -1.7; -1.7 | — |
| SECONDARY Adjusted Change From Baseline in Dactylitis Count |
-1.8; -2.0; -2.5 | — |
| SECONDARY Adjusted Change From Baseline in the Leeds Dactylitis Index (LDI) Basic Score |
-28.3; -41.8; -44.5 | — |
| SECONDARY Percentage of Participants Achieving Dactylitis Resolution |
60.0; 76.7; 79.2 | — |
| SECONDARY Adjusted Change From Baseline in Enthesitis by the Leeds Enthesitis Index (LEI) |
-1.2; -1.5; -1.7 | — |
| SECONDARY Adjusted Change From Baseline in Enthesitis by the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index |
-1.2; -2.9; -3.1 | — |
| SECONDARY Percentage of Participants Achieving Enthesitis Resolution by the Leeds Enthesitis Index (LEI) |
22.6; 51.3; 50.0 | — |
| SECONDARY Percentage of Participants Achieving Enthesitis Resolution by the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index |
17.6; 51.2; 41.2 | — |
| SECONDARY Percentage of Participants Achieving a Physicians Global Assessment-Fingernails (PGA-F) Score of 0 or 1 |
0; 21.4; 50.0 | — |
| SECONDARY Percentage of Participants Achieving Minimal Disease Activity (MDA) Response |
7.6; 22.9; 23.9 | — |
| SECONDARY Adjusted Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) |
-1.1; -2.0; -2.1 | — |
| SECONDARY Adjusted Change From Baseline in the Disease Activity Index for Psoriatic Arthritis Score (DAPSA) |
-13.3; -23.2; -25.6 | — |
| SECONDARY Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) |
54.5; 75.7; 74.6 | — |
| SECONDARY Adjusted Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) |
-1.7; -2.0; -2.2 | — |
| SECONDARY Adjusted Change From Baseline in the Mental Component Summary (MCS) Score of the Short Form Health Survey-36 (SF-36) Questionnaire |
0.7; 3.6; 3.5 | — |
| SECONDARY Adjusted Change From Baseline in the Psoriatic Arthritis Impact of Disease (PsAID) 12 Score |
-1.0; -2.1; -2.3 | — |
| SECONDARY Adjusted Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score |
2.8; 5.6; 7.2 | — |
| SECONDARY Adjusted Change From Baseline in the Work Limitation Questionnaire (WLQ) Score |
-1.2; -1.9; -2.7 | — |
| SECONDARY Percentage of Participants Achieving Health Assessment Questionnaire-Disability Index (HAQ-DI) 0.35 Response |
15.2; 38.6; 40.3 | — |
| SECONDARY Percentage of Participants Achieving the Psoriasis Area and Severity Index (PASI) 90 Response |
9.3; 20.3; 34.6 | — |
| SECONDARY Change From Baseline in Electrocardiogram (ECG) Results |
3.9; 3.2; -2.9; -0.5; 3.9; -1.1 | — |
| SECONDARY Change From Baseline in Electrocardiogram (ECG) Heart Rate |
-0.7; -1.0; 0.0 | — |
| SECONDARY Change From Baseline in Vital Signs - Diastolic Blood Pressure |
1.1; -0.9; -1.7 | — |
| SECONDARY Change From Baseline in Vital Signs - Heart Rate |
0.7; -2.5; 0.8 | — |
| SECONDARY Change From Baseline in Vital Signs - Respiratory Rate |
0.0; -0.2; 0.2 | — |
| SECONDARY Change From Baseline in Vital Signs - Systolic Blood Pressure |
1.6; -0.6; -1.5 | — |
| SECONDARY Change From Baseline in Vital Signs - Temperature |
-0.05; -0.07; -0.06 | — |
| SECONDARY Change From Baseline in Vital Signs - Weight |
-0.24; 0.18; 0.43 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with PsA for at least 6 months before screening, and who meet the Classification Criteria for Psoriatic Arthritis (CASPAR) at screening
- Participants either (i) cannot have prior exposure to biologics (biologic-naïve) or (ii) have failed or been intolerant to 1 tumor necrosis factor -inhibitor (TNFi) (TNFi-experienced). Failure is defined as lack of response or loss of response with at least 3 months of therapy with an approved dose of a TNFi, as judged by the investigator. Failure must have occurred at least 2 months prior to Day 1
- Participants have at least 1 confirmed greater than or equal to (>=) 2 centimeter (cm) lesion of plaque psoriasis at screening
- Participants have active arthritis as shown by a minimum of >= 3 swollen joints and >= 3 tender joints (66/68 joint counts) at screening and Day 1
- High sensitivity C-reactive protein (hsCRP) >= 3milligram per liter (mg/L) at screening
- Women of Childbearing Potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the start of study treatment
Exclusion Criteria
- Has non-plaque psoriasis (that is (i.e.), guttate, inverse, pustular, erythrodermic or drug-induced psoriasis) at screening or Day 1
- Has any other autoimmune condition such as rheumatoid arthritis, etc. There are exceptions for inflammatory bowel disease or uveitis as follows: currently active disease is excluded but, a history of no longer active disease for at least 12 months (including not being on medication) is allowed
- Has active (i.e. currently symptomatic) fibromyalgia
- History or evidence of active infection and/or febrile illness within 7 days prior to Day 1 (example, bronchopulmonary, urinary, gastrointestinal, etc.)
- History of recent serious bacterial, fungal, or viral infections requiring hospitalization and intravenous (IV) antimicrobial treatment within 90 days prior to screening, or any infection requiring antimicrobial treatment within 15 days prior to Day 1
- History of active tuberculosis (TB) prior to screening visit, regardless of completion of adequate treatment
Data sourced from ClinicalTrials.gov (NCT03881059). 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.