Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Autoimmune Disorder, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Primary Sjögren's Syndrome

In brief

The purpose of this study is to evaluate the safety and effectiveness of treatment with branebrutinib treatment in participants with active systemic Lupus Erythematosus (SLE) or Primary Sjögren's Syndrome (pSS), or branebrutinib treatment followed by open-label abatacept treatment in study participants with active Rheumatoid Arthritis (RA).

Key facts

Study ID

NCT04186871

Run by

Bristol-Myers Squibb

People needed

119

Starts

2020-01-07

Expected to finish

2022-12-05

Last updated by the study team

2024-01-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Sub-study for Systemic Lupus Erythematosus (SLE)
• Active SLE as defined by the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) classification
• Diagnosed with SLE more than 24 weeks before screening visit
• Sub-study for primary Sjögren's Syndrome (pSS)
• Moderate to severe pSS, meeting ACR-EULAR classification criteria
• Sub-study for active Rheumatoid Arthritis (RA)
• Moderate to severe adult-onset RA
• ACR global functional status class I to III
• Women and men must agree to follow instructions for methods of contraception.

You may not qualify if…

• Sub-study for SLE
• Certain other autoimmune diseases and overlap syndromes
• Sub-study for pSS
• Certain other immune-mediated diseases, active fibromyalgia, or other medical conditions
• Sub-study for RA
• Diagnosis with juvenile arthritis or idiopathic arthritis before age 16
• For all sub-studies:
• History of any significant drug allergy
• Active infection, significant concurrent medical condition, or clinically significant abnormalities
• Other protocol defined inclusion/exclusion criteria could apply

Where it is running

• Local Institution - 0002 — Covina, California, United States
• Local Institution - 0024 — Encino, California, United States
• Local Institution - 0034 — San Diego, California, United States
• Local Institution - 0032 — Upland, California, United States
• Local Institution — Brandon, Florida, United States
• Local Institution - 0062 — DeBary, Florida, United States
• Local Institution - 0035 — Hialeah, Florida, United States
• Local Institution — Jacksonville, Florida, United States
• Local Institution - 0029 — Plantation, Florida, United States
• Local Institution - 0009 — Lawrenceville, Georgia, United States
• Local Institution - 0014 — Skokie, Illinois, United States
• Local Institution — Evansville, Indiana, United States
• Local Institution - 0005 — Monroe, Louisiana, United States
• Local Institution - 0041 — Ann Arbor, Michigan, United States
• Local Institution - 0082 — Grand Blanc, Michigan, United States
• Local Institution - 0096 — St Louis, Missouri, United States
• Local Institution - 0040 — St Louis, Missouri, United States
• Local Institution - 0056 — Lincoln, Nebraska, United States
• Local Institution - 0007 — Las Vegas, Nevada, United States
• Local Institution — Manhasset, New York, United States
• Local Institution — New York, New York, United States
• Local Institution - 0008 — Charlotte, North Carolina, United States
• Local Institution - 0006 — Salisbury, North Carolina, United States
• Local Institution — Minot, North Dakota, United States
• Local Institution - 0019 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.