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

NCT04186871 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IM014-0292019-002205-22
• Study Type: interventional
• Target: 119
• Locations: 10 countries
• Sites: 81

Brief Summary

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).

Conditions

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

Outcome Measures

Primary Outcomes (3)

• The Percent of Participants With mCLASI Response at Week 24 and Corticosteroid (CS) < 10 mg/Day at Week 20 and Week 24 - SLE

  mCLASI response is defined as a decrease of ≥ 50% from baseline mCLASI activity score, in participants with a baseline mCLASI activity score ≥ 10, at Week 24. Baseline values are defined as the last nonmissing value prior to the first dose of study treatment. To be considered as meeting the second criterion, the CS (prednisone or equivalent) dose had to remain stable and ≤ 10 mg from Week 16 until Week 24. The modified CLASI (mCLASI) is defined as the activity portions of CLASI that describe skin erythema and scale/hypertrophy and inflammation of the scalp. The percentage of patients who entered the study with a positive mCLASI activity score (≥ 10) and who achieved a ≥ 50% decrease from baseline at Week 24 is considered to likely represent a clinically meaningful improvement. The scores are calculated by simple addition based on the extent of the symptoms. mCLASI: Modified Cutaneous Lupus Erythematosus Disease Area and Severity Index

  Week 24

• The Percent of Participants With Composite Response at Week 24 - pSS

  Composite response is defined as the percent of participants with at least 3 of the following at Week 24: * Decrease of ≥ 1 point or 15% from baseline in the ESSPRI Total Score * Decrease of ≥ 3 points from baseline in ESSDAI score * Decrease of ≥ 25% from baseline in ocular staining score, or if normal score at baseline no change to abnormal * Increase of ≥ 25% from baseline in stimulated salivary flow * Improvement in one or more serological markers (rheumatoid factor (RF), immunoglobulin G protein (IgG), complement C3 or C4, cryoglobulin).

  Week 24

• Percent of Participants With ACR50 Response at Week 12 Compared to Baseline - RA

  ACR50 response is defined as both improvement of 50% in the number of tender and swollen joints and a 50% improvement in 3 of the following 5 criteria: * Subject global assessment (SGA) * Physician global assessment (PGA) * Functional ability measure * Pain visual analog scale (VAS) * Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). Baseline values are defined as the last nonmissing value prior to the first dose of study treatment.

  Week 12

Secondary Outcomes (8)

• Change From Baseline in SLEDAI-2K Score at Week 24 - SLE

  Week 24

• Percent of Participants With BICLA Response at Week 24 - SLE

  Week 24

• Change From Baseline in DAS28-CRP at Week 12 - RA

  Week 12

• Change From Baseline in DAS28-ESR at Week 12 - RA

  Week 12

• Change From Baseline in SDAI at Week 12- RA

  Week 12

Study Arms (6)

Systemic Lupus Erythematosus (SLE): branebrutinib

EXPERIMENTAL

Drug: branebrutinib

SLE: placebo

PLACEBO COMPARATOR

Drug: branebrutinib placebo

Primary Sjögren's Syndrome (pSS): branebrutinib

EXPERIMENTAL

Drug: branebrutinib

pSS: placebo

PLACEBO COMPARATOR

Drug: branebrutinib placebo

Rheumatoid Arthritis (RA): branebrutinib followed by abatacept

EXPERIMENTAL

Drug: branebrutinib; Drug: abatacept

RA: placebo followed by abatacept

PLACEBO COMPARATOR

Drug: abatacept; Drug: branebrutinib placebo

Interventions

branebrutinib DRUG

Specified dose on specified days

Primary Sjögren's Syndrome (pSS): branebrutinib; Rheumatoid Arthritis (RA): branebrutinib followed by abatacept; Systemic Lupus Erythematosus (SLE): branebrutinib

abatacept DRUG

Specified dose on specified days

RA: placebo followed by abatacept; Rheumatoid Arthritis (RA): branebrutinib followed by abatacept

branebrutinib placebo DRUG

Specified dose on specified days

RA: placebo followed by abatacept; SLE: placebo; pSS: placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (81)

Local Institution - 0019

Phoenix, Arizona, 85032, United States

Location

Local Institution - 0002

Covina, California, 91723, United States

Location

Local Institution - 0024

Encino, California, 91436, United States

Location

Local Institution - 0034

San Diego, California, 92108, United States

Location

Local Institution - 0032

Upland, California, 91786, United States

Location

Local Institution

Brandon, Florida, 33511, United States

Location

Local Institution - 0062

DeBary, Florida, 32713, United States

Location

Local Institution - 0035

Hialeah, Florida, 33016, United States

Location

Local Institution

Jacksonville, Florida, 32209, United States

Location

Local Institution - 0029

Plantation, Florida, 33324, United States

Location

Local Institution - 0009

Lawrenceville, Georgia, 30046, United States

Location

Local Institution - 0014

Skokie, Illinois, 60076, United States

Location

Local Institution

Evansville, Indiana, 47715, United States

Location

Local Institution - 0005

Monroe, Louisiana, 71203, United States

Location

Local Institution - 0041

Ann Arbor, Michigan, 48109, United States

Location

Local Institution - 0082

Grand Blanc, Michigan, 48439, United States

Location

Local Institution - 0096

St Louis, Missouri, 63131, United States

Location

Local Institution - 0040

St Louis, Missouri, 63141, United States

Location

Local Institution - 0056

Lincoln, Nebraska, 68516, United States

Location

Local Institution - 0007

Las Vegas, Nevada, 89119, United States

Location

Local Institution

Manhasset, New York, 11030, United States

Location

Local Institution

New York, New York, 10016, United States

Location

Local Institution - 0008

Charlotte, North Carolina, 28204, United States

Location

Local Institution - 0006

Salisbury, North Carolina, 28144, United States

Location

Local Institution

Minot, North Dakota, 58701, United States

Location

Local Institution - 0023

Oklahoma City, Oklahoma, 73103-2433, United States

Location

Local Institution - 0022

Oklahoma City, Oklahoma, 79112, United States

Location

Local Institution - 0010

Duncansville, Pennsylvania, 16635, United States

Location

Local Institution - 0045

Orangeburg, South Carolina, 29118, United States

Location

Local Institution - 0021

Summerville, South Carolina, 29486, United States

Location

Local Institution - 0079

Jackson, Tennessee, 38305, United States

Location

Local Institution - 0001

Memphis, Tennessee, 38119, United States

Location

Local Institution - 0092

Colleyville, Texas, 76034, United States

Location

Local Institution

Dallas, Texas, 75231, United States

Location

Local Institution - 0063

Houston, Texas, 77084, United States

Location

Local Institution - 0016

Mesquite, Texas, 75150, United States

Location

Local Institution - 0030

Plano, Texas, 75024, United States

Location

Local Institution - 0031

San Antonio, Texas, 78215, United States

Location

Local Institution

Waco, Texas, 76710, United States

Location

Local Institution - 0083

Spokane, Washington, 99204, United States

Location

Local Institution - 0065

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1431FWO, Argentina

Location

Local Institution - 0047

San Miguel de Tucum, Tucumán Province, T4000AXL, Argentina

Location

Local Institution - 0066

San Juan, J5402DIL, Argentina

Location

Local Institution - 0064

Ghent, 9000, Belgium

Location

Local Institution - 0069

Leuven, 3000, Belgium

Location

Local Institution - 0075

Brest, 29609, France

Location

Local Institution - 0070

Marseille, 13003, France

Location

Local Institution - 0067

Montpellier, 34295, France

Location

Local Institution - 0038

Berlin, 10117, Germany

Location

Local Institution - 0037

Cologne, 50937, Germany

Location

Local Institution - 0049

Freiburg im Breisgau, 79106, Germany

Location

Local Institution - 0074

Herne, 44649, Germany

Location

Local Institution - 0051

München, 80336, Germany

Location

Local Institution - 0060

Guadalajara, Jalisco, 44160, Mexico

Location

Local Institution - 0042

Guadalajara, Jalisco, 44650, Mexico

Location

Local Institution - 0113

Zapopan, Jalisco, 45070, Mexico

Location

Local Institution - 0102

Cuernavaca, Morelos, 62290, Mexico

Location

Local Institution - 0104

Mérida, Yucatán, 97000, Mexico

Location

Local Institution - 0114

San Luis Potosí City, 78200, Mexico

Location

Local Institution - 0050

San Luis Potosí City, 78213, Mexico

Location

Local Institution - 0059

San Luis Potosí City, 78240, Mexico

Location

Local Institution - 0004

Groningen, 9713 GZ, Netherlands

Location

Local Institution - 0094

Bialystok, 15-879, Poland

Location

Local Institution - 0089

Bydgoszcz, 85-065, Poland

Location

Local Institution - 0072

Bydgoszcz, 85-168, Poland

Location

Local Institution - 0012

Elblag, 82-300, Poland

Location

Local Institution - 0073

Elblag, 82-300, Poland

Location

Local Institution - 0011

Poznan, 60-773, Poland

Location

Local Institution - 0091

Torun, 87-100, Poland

Location

Local Institution - 0017

Warsaw, 00-660, Poland

Location

Local Institution - 0033

Warsaw, 02-691, Poland

Location

Local Institution - 0101

Warsaw, 02-793, Poland

Location

Local Institution - 0026

Warsaw, 03-291, Poland

Location

Local Institution - 0028

A Coru, 15006, Spain

Location

Local Institution - 0036

Barcelona, 08035, Spain

Location

Local Institution - 0025

Málaga, 29010, Spain

Location

Local Institution - 0018

Seville, 41010, Spain

Location

Local Institution - 0061

Valencia, 46010, Spain

Location

Local Institution - 0076

Leeds, LS7 4SA, United Kingdom

Location

Local Institution - 0058

London, SE1 9RT, United Kingdom

Location

Local Institution - 0052

Southampton, SO16 6YD, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Autoimmune Diseases; Arthritis, Rheumatoid; Lupus Erythematosus, Systemic

Interventions

branebrutinib; Abatacept

Condition Hierarchy (Ancestors)

Immune System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 5, 2019
• Study Start: January 7, 2020
• Primary Completion: December 5, 2022
• Study Completion: December 5, 2022
• Last Updated: January 16, 2024
• Results First Posted: January 16, 2024

Record last verified: 2024-01

Locations

ES (5); US (40); BE (2); DE (5); AR (3); FR (3); NL (1); ME (8); PL (11); GB (3)