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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

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

Treatments: Drug: abatacept; Drug: branebrutinib; Drug: branebrutinib placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04186871

IM014-029

2019-002205-22 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 119 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

119 participants in 6 patient groups, including a placebo group

Systemic Lupus Erythematosus (SLE): branebrutinib

Experimental group

Treatment:

Drug: branebrutinib

SLE: placebo

Placebo Comparator group

Treatment:

Drug: branebrutinib placebo

Primary Sjögren's Syndrome (pSS): branebrutinib

Experimental group

Treatment:

Drug: branebrutinib

pSS: placebo

Placebo Comparator group

Treatment:

Drug: branebrutinib placebo

Rheumatoid Arthritis (RA): branebrutinib followed by abatacept

Experimental group

Treatment:

Drug: abatacept

Drug: branebrutinib

RA: placebo followed by abatacept

Placebo Comparator group

Treatment:

Drug: abatacept

Drug: branebrutinib placebo