| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE2 | COMPLETED | 119 | — | — | Jan 7, 2020 | Dec 5, 2022 | Jan 16, 2024 | 81 | United States, Argentina +8 |
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
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).
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.
| Arm | Type | Description |
|---|---|---|
| Systemic Lupus Erythematosus (SLE): branebrutinib | EXPERIMENTAL | - |
| SLE: placebo | PLACEBO_COMPARATOR | - |
| Primary Sjögren's Syndrome (pSS): branebrutinib | EXPERIMENTAL | - |
| pSS: placebo | PLACEBO_COMPARATOR | - |
| Rheumatoid Arthritis (RA): branebrutinib followed by abatacept | EXPERIMENTAL | - |
| RA: placebo followed by abatacept | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| branebrutinib | DRUG | Specified dose on specified days |
| abatacept | DRUG | Specified dose on specified days |
| branebrutinib placebo | DRUG | Specified dose on specified days |
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)...