Trial · NCT04186871

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, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2024-01-16

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. 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. Trials, record NCT04186871. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04186871

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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
NCT number: NCT04186871
Status: Completed
Phases: Phase 2
Enrollment: 119 participants, actual
Lead sponsor: Bristol-Myers Squibb
Conditions: Autoimmune Disorder, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Primary Sjögren's Syndrome
Interventions: branebrutinib, abatacept, branebrutinib placebo
First posted: 2019-12-05
Last updated: 2024-01-16
Other registries' IDs: eudract:2019-002205-22
Results first posted: 2024-01-16

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Percent of Participants With mCLASI Response at Week 24 and Corticosteroid (CS) < 10 mg/Day at Week 20 and Week 24 - SLE	Week 24	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
Primary	The Percent of Participants With Composite Response at Week 24 - pSS	Week 24	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).
Primary	Percent of Participants With ACR50 Response at Week 12 Compared to Baseline - RA	Week 12	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.
Secondary	Change From Baseline in SLEDAI-2K Score at Week 24 - SLE	Week 24	The SLEDAI-2K is a global index providing a total score of overall disease activity ranging from 0 to 105, with higher scores representing more active disease. The SLEDAI index includes 24 items divided into 9 organ systems: neurological, musculoskeletal, renal, mucocutaneous, general, heart, respiratory, vascular, and hematological. Each item is scored based on the severity of the symptom or finding, with higher scores indicating more severe disease activity. The weighted scores for each item range from 0 to 8. To calculate the SLEDAI-2K score, the scores for each of the 24 items are added together. Baseline values are defined as the last nonmissing value prior to the first dose of study treatment.
Secondary	Percent of Participants With BICLA Response at Week 24 - SLE	Week 24	BILAG-based composite lupus assessment (BICLA) response is defined as: 1. At least one gradation of improvement in baseline BILAG scores in all body systems with moderate or severe disease activity at entry 2. No new BILAG A or more than one new BILAG B scores 3. No worsening of total SLEDAI score from baseline 4. No significant deterioration (\< 10%) in PGA and 5. No treatment failure (initiation of nonprotocol treatment). BILAG scores: A (severe disease), B (moderate), C (mild), or D (no activity). Baseline values are defined as the last nonmissing value prior to the first dose of study treatment.
Secondary	Change From Baseline in DAS28-CRP at Week 12 - RA	Week 12	The Disease Activity Score-28-C-Reactive Protein (DAS28CRP) is a composite outcome assessment that measures: 1) How many joints in the hands, wrists, elbows, shoulders, and knees are swollen and/or tender over a total of 28, 2) CRP in the blood to measure the degree of inflammation, and 3) SGA of disease activity. DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. The results are combined to produce the DAS28-CRP score, which correlates with the extent of disease activity: \< 2.6: Disease remission 2.6 - 3.2: Low disease activity 3.2 - 5.1: Moderate disease activity \> 5.1: High disease activity A negative change from baseline in DAS28-CRP indicates an improvement. Baseline values are defined as the last nonmissing value prior to the first dose of study treatment.
Secondary	Change From Baseline in DAS28-ESR at Week 12 - RA	Week 12	The Disease Activity Score Erythrocyte Sedimentation Rate - DAS28ESR is a composite outcome assessment that measures: 1. How many joints in the hands, wrists, elbows, shoulders, and knees are swollen and/or tender over a total of 28 2. ESR in the blood to measure the degree of inflammation 3. SGA of disease activity DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. The results are combined to produce the DAS28-ESR score, which correlates with the extent of disease activity: \< 2.6: Disease remission 2.6 - 3.2: Low disease activity 3.2 - 5.1: Moderate disease activity \> 5.1: High disease activity A negative change from baseline in DAS28-ESR indicates an improvement. Baseline values are defined as the last nonmissing value prior to the first dose of study treatment.
Secondary	Change From Baseline in SDAI at Week 12- RA	Week 12	The Simplified Disease Activity Index (SDAI) is the sum of the tender joint score (range 0 to 28), the swollen joint score (range 0 to 28), the subject global assessment (SGA) of disease activity (range 0 to 10 in increments of 0.5), the PGA of disease activity (range 0 to 10 in increments of 0.5), and C-reactive protein (CRP) test result. Baseline values are defined as the last nonmissing value prior to the first dose of study treatment. A SDAI score ranges from 0 (disease remission) to 86 (high disease activity).
Secondary	Change From Baseline in CDAI at Week 12 - RA	Week 12	The Clinical Disease Activity Index (CDAI) is the sum of the tender joint score (range 0 to 28), the swollen joint score (range 0 to 28), the SGA of disease activity (range 0 to 10 in increments of 0.5), and the PGA of disease activity (range 0 to 10 in increments of 0.5). Baseline values are defined as the last nonmissing value prior to the first dose of study treatment. A CDAI score ranges from 0 to 76. The interpretation of CDAI is as follows: 0.0 - 2.8: Disease remission 2.9 - 10.0: Low disease activity (LDA) 10.1 - 22.0: Moderate disease activity 22.1 - 76.0: High disease activity
Secondary	Percent of Participants With ACR20 Response Compared to Baseline at Week 12 - RA	Week 12	ACR20 defined as both improvement of 20% in the number of tender and swollen joints and a 20% 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.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Percent of Participants With mCLASI Response at Week 24 and Corticosteroid (CS) < 10 mg/Day at Week 20 and Week 24 - SLE	Week 24	All treated participants with a baseline mCLASI activity score ≥ 10 at Week 24 (Prespecified for participants in the SLE cohort only).	Percentage of participants	NUMBER
SECONDARY	Change From Baseline in SLEDAI-2K Score at Week 24 - SLE	Week 24	All Treated Participants with week 24 measurements (Prespecified for participants in the SLE cohort only).	Change in score on a scale	MEAN
SECONDARY	Percent of Participants With BICLA Response at Week 24 - SLE	Week 24	All Treated Participants (Prespecified for participants in the SLE cohort only).	Percent of participants	NUMBER
PRIMARY	The Percent of Participants With Composite Response at Week 24 - pSS	Week 24	All Treated Participants (Prespecified for participants in the pSS cohort only).	Percent of Participants	NUMBER
PRIMARY	Percent of Participants With ACR50 Response at Week 12 Compared to Baseline - RA	Week 12	All Treated Participants (Prespecified for participants in the RA cohort only).	Percent of Participants	NUMBER
SECONDARY	Change From Baseline in DAS28-CRP at Week 12 - RA	Week 12	All Treated Participants with baseline and week 12 measurements (Prespecified for participants in the RA cohort only).	Score on a scale	MEAN
SECONDARY	Change From Baseline in DAS28-ESR at Week 12 - RA	Week 12	All treated participants with baseline and week 12 measurements (Prespecified for participants in the RA cohort only).	Score on a scale	MEAN
SECONDARY	Change From Baseline in SDAI at Week 12- RA	Week 12	All treated participants with baseline and week 12 measurements (Prespecified for participants in the RA cohort only).	Score on a scale	MEAN
SECONDARY	Change From Baseline in CDAI at Week 12 - RA	Week 12	All treated participants with baseline and week 12 measurements (Prespecified for participants in the RA cohort only).	Score on a scale	MEAN
SECONDARY	Percent of Participants With ACR20 Response Compared to Baseline at Week 12 - RA	Week 12	All Treated Participants (Prespecified for participants in the RA cohort only).	Percent of Participants	NUMBER

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group22

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
The Percent of Participants With mCLASI Response at Week 24 and Corticosteroid (CS) < 10 mg/Day at Week 20 and Week 24 - SLE	SLE- Placebo	60.0	95% Confidence Interval 17.1 to 100	Percentage of participants
The Percent of Participants With mCLASI Response at Week 24 and Corticosteroid (CS) < 10 mg/Day at Week 20 and Week 24 - SLE	SLE- Branebrutinib	33.3	95% Confidence Interval 9.5 to 57.2	Percentage of participants
Change From Baseline in SLEDAI-2K Score at Week 24 - SLE	SLE- Placebo	-7.0	Standard Deviation 5.29	Change in score on a scale
Change From Baseline in SLEDAI-2K Score at Week 24 - SLE	SLE- Branebrutinib	-7.0	Standard Deviation 6.54	Change in score on a scale
Percent of Participants With BICLA Response at Week 24 - SLE	SLE- Placebo	20.0	95% Confidence Interval 0.5 to 71.6	Percent of participants
Percent of Participants With BICLA Response at Week 24 - SLE	SLE- Branebrutinib	33.3	95% Confidence Interval 11.8 to 61.6	Percent of participants
The Percent of Participants With Composite Response at Week 24 - pSS	pSS- Placebo	25	95% Confidence Interval 0.0 to 67.4	Percent of Participants
The Percent of Participants With Composite Response at Week 24 - pSS	pSS- Branebrutinib	10	95% Confidence Interval 0.0 to 28.6	Percent of Participants
Percent of Participants With ACR50 Response at Week 12 Compared to Baseline - RA	RA- Placebo	33.3	95% Confidence Interval 13.2 to 53.5	Percent of Participants
Percent of Participants With ACR50 Response at Week 12 Compared to Baseline - RA	RA- Branebrutinib	18.8	95% Confidence Interval 9.2 to 28.3	Percent of Participants

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow30

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	SLE- Placebo	5
Overall Study	STARTED	SLE- Branebrutinib	15
Overall Study	STARTED	pSS- Placebo	4
Overall Study	STARTED	pSS- Branebrutinib	10
Overall Study	STARTED	RA- Placebo	21
Overall Study	STARTED	RA- Branebrutinib	64
Overall Study	Double Blind Period	SLE- Placebo	5
Overall Study	Double Blind Period	SLE- Branebrutinib	15
Overall Study	Double Blind Period	pSS- Placebo	4
Overall Study	Double Blind Period	pSS- Branebrutinib	10

1 to 10 of 30Source ClinicalTrials.gov

See all 30 participant flow

Adverse events308

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Thrombocytopenia	Blood and lymphatic system disorders	SLE- Placebo	0	5
other	Thrombocytopenia	Blood and lymphatic system disorders	SLE- Branebrutinib	1	15
other	Thrombocytopenia	Blood and lymphatic system disorders	pSS- Placebo	0	4
other	Thrombocytopenia	Blood and lymphatic system disorders	pSS- Branebrutinib	0	10
other	Thrombocytopenia	Blood and lymphatic system disorders	RA- Placebo	0	21
other	Thrombocytopenia	Blood and lymphatic system disorders	RA- Branebrutinib	0	64
other	Thrombocytopenia	Blood and lymphatic system disorders	RA Abatacept	0	81
other	Atrioventricular block first degree	Cardiac disorders	SLE- Placebo	0	5
other	Atrioventricular block first degree	Cardiac disorders	SLE- Branebrutinib	1	15
other	Atrioventricular block first degree	Cardiac disorders	pSS- Placebo	0	4

1 to 10 of 308Source ClinicalTrials.gov

See all 308 adverse events

Adverse event totals21

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SLE- Placebo	0	5
Total, all-cause mortality	SLE- Branebrutinib	0	15
Total, all-cause mortality	pSS- Placebo	0	4
Total, all-cause mortality	pSS- Branebrutinib	0	10
Total, all-cause mortality	RA- Placebo	0	21
Total, all-cause mortality	RA- Branebrutinib	0	64
Total, all-cause mortality	RA Abatacept	0	81
Total, other adverse events	SLE- Placebo	4	5
Total, other adverse events	SLE- Branebrutinib	14	15
Total, other adverse events	pSS- Placebo	4	4

1 to 10 of 21Source ClinicalTrials.gov

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Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
42081904	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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