Phase 3
Completed N=778
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE-BRAVE II)
Systemic Lupus Erythematosus
Source: ClinicalTrials.gov NCT03616964 ↗
Enrolled (actual)
778
Serious AEs
12.0%
Results posted
Nov 2022
Primary outcomePrimary: Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib) — 45.6; 47.1 percentage of participants — p=0.711
◆ Published Evidence
Highly cited
162citations · ~54 / year
Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-II).
Summary
The reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE).
Linked Publications (3)
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Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-II).
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Interventions for cutaneous disease in systemic lupus erythematosus.
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Clinical outcomes of baricitinib in patients with systemic lupus erythematosus: Pooled analysis of SLE-BRAVE-I and SLE-BRAVE-II trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib) |
45.6; 47.1 | 0.711 |
| SECONDARY Percentage of Participants Achieving SRI-4 Response (2 mg Baricitinib) |
45.6; 46.3 | 0.789 |
| SECONDARY Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS) |
23.2; 24.0; 25.4 | 0.673 |
| SECONDARY Time to First Severe Flare |
NA; NA; NA | — |
| SECONDARY Percentage of Participants Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Participants Receiving Greater Than 7.5 mg/Day at Baseline |
31.7; 29.8; 34.3 | 0.761 |
| SECONDARY Change From Baseline in Worst Pain Numeric Rating Scale (NRS) |
-1.37; -1.45; -1.44 | 0.698 |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Total Score |
7.26; 6.90; 6.96 | 0.665 |
| SECONDARY Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Total Activity Score ≥10 at Baseline With ≥50% Reduction in CLASI Total Activity Score |
66.1; 56.9; 58.0 | 0.372 |
| SECONDARY Change From Baseline in Tender Joint Count |
-6.92; -7.40; -7.83 | 0.251 |
| SECONDARY Change From Baseline in Swollen Joint Count |
-4.79; -5.10; -5.31 | 0.284 |
| SECONDARY Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve for Dosing Interval of Baricitinib at Steady State (AUCtau,ss) |
257; 505 | — |
| SECONDARY Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) |
27.0; 54.1 | — |
Eligibility Criteria
Inclusion Criteria
- Have a clinical diagnosis of SLE at least 24 weeks prior to screening.
- Have documentation of having met at least 4 of 11 Revised Criteria for Classification of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 American College of Rheumatology (ACR) criteria for classification of SLE prior to randomization.
- Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA), and/or a positive anti-Smith (anti-Sm) as assessed by a central laboratory during screening.
- Have a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 during screening.
- Have a clinical SLEDAI-2K score ≥4 at randomization.
- Have at least 1 British Isles Lupus Assessment Group (BILAG) A score or 2 BILAG B scores during screening.
- Are receiving at least one of the following standard of care medications for SLE:
- A single antimalarial at a stable dose for at least 8 weeks prior to screening
- A single immunosuppressant at a stable dose for at least 8 weeks prior to screening
- An oral corticosteroid, initiated at least 4 weeks prior to screening, at a stable dose ≤40 milligrams/day prednisone (or equivalent) for at least 2 weeks prior to screening. If the participant is not receiving an antimalarial or immunosuppressant, the dose of corticosteroid must be ≥7.5 milligrams/day prednisone (or equivalent)
Exclusion Criteria
- Have severe active lupus nephritis.
- Have active central nervous system (CNS) lupus.
- Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.
- Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.
- Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.
Data sourced from ClinicalTrials.gov (NCT03616964) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.