A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (BRAVE II)
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ClinicalTrials.gov Identifier: NCT03616964 |
Recruitment Status :
Active, not recruiting
First Posted : August 6, 2018
Last Update Posted : March 19, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Systemic Lupus Erythematosus | Drug: Baricitinib Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 750 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus |
Actual Study Start Date : | August 2, 2018 |
Estimated Primary Completion Date : | October 15, 2021 |
Estimated Study Completion Date : | November 15, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Baricitinib High Dose
Baricitinib administered orally. Placebo administered orally to maintain the blind.
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Drug: Baricitinib
Administered orally.
Other Name: LY3009104 Drug: Placebo Administered orally |
Experimental: Baricitinib Low Dose
Baricitinib administered orally. Placebo administered orally to maintain the blind.
|
Drug: Baricitinib
Administered orally.
Other Name: LY3009104 Drug: Placebo Administered orally |
Placebo Comparator: Placebo
Placebo administered orally.
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Drug: Placebo
Administered orally |
- Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (High Dose) [ Time Frame: Week 52 ]Percentage of participants achieving SRI-4 response (high dose).
- Percentage of Participants Achieving SRI-4 Response (Low Dose) [ Time Frame: Week 52 ]Percentage of participants achieving SRI-4 response (low dose).
- Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS) [ Time Frame: Week 52 ]Percentage of Participants Achieving a LLDAS.
- Time to First Severe Flare [ Time Frame: Baseline to Week 52 ]Time to first severe flare.
- Change from Baseline in Prednisone Dose [ Time Frame: Baseline, Week 52 ]Change from baseline in prednisone dose.
- Change from Baseline in Worst Pain Numeric Rating Scale (NRS) [ Time Frame: Baseline, Week 52 ]Change from baseline in worst pain NRS.
- Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Total Score [ Time Frame: Baseline, Week 52 ]Change from baseline on FACIT-Fatigue total score.
- 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 [ Time Frame: Week 52 ]Percentage of participants with CLASI total activity score ≥10 at baseline with ≥50% reduction in CLASI total activity score.
- Change from Baseline in Tender Joint Count [ Time Frame: Baseline, Week 52 ]Change from baseline in tender joint count.
- Change from Baseline in Swollen Joint Count [ Time Frame: Baseline, Week 52 ]Change from baseline in swollen joint count.
- Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss) [ Time Frame: Baseline through Week 16 ]PK: Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss).
- Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) [ Time Frame: Baseline through Week 16 ]Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616964

Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT03616964 |
Other Study ID Numbers: |
16677 I4V-MC-JAIA ( Other Identifier: Eli Lilly and Company ) 2017-005027-25 ( EudraCT Number ) |
First Posted: | August 6, 2018 Key Record Dates |
Last Update Posted: | March 19, 2021 |
Last Verified: | March 15, 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
SLE |
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |