A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (BRAVE I)

• ClinicalTrials.gov Identifier: NCT03616912
• Recruitment Status: Recruiting
• First Posted: August 6, 2018
• Last Update Posted: December 4, 2019
• Sponsor: Eli Lilly and Company
• Collaborator: Incyte Corporation
• Information provided by (Responsible Party): Eli Lilly and Company

Tracking Information

• First Submitted Date: August 1, 2018
• First Posted Date: August 6, 2018
• Last Update Posted Date: December 4, 2019
• Actual Study Start Date: August 2, 2018
• Estimated Primary Completion Date: May 21, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 1, 2018)

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).

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03616912 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: August 1, 2018)

• 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).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus
• Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus
• Brief 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Systemic Lupus Erythematosus

Intervention

• Drug: Baricitinib
  Administered orally.
  Other Name: LY3009104
• Drug: Placebo
  Administered orally.

Study Arms

• Experimental: Baricitinib High Dose
  Baricitinib administered orally. Placebo administered orally to maintain the blind.
  Interventions:

  • Drug: Baricitinib
  • Drug: Placebo
• Experimental: Baricitinib Low Dose
  Baricitinib administered orally. Placebo administered orally to maintain the blind.
  Interventions:

  • Drug: Baricitinib
  • Drug: Placebo
• Placebo Comparator: Placebo
  Placebo administered orally.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 1, 2018): 750
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 21, 2021
• Estimated Primary Completion Date: May 21, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or; 1-317-615-4559; clinicaltrials.gov@lilly.com

• Listed Location Countries: Australia, Austria, Belgium, Brazil, China, Croatia, Czechia, Germany, Greece, Hungary, Israel, Mexico, Netherlands, Russian Federation, Switzerland, Taiwan, United Kingdom, United States
• Removed Location Countries: Ukraine

Administrative Information

• NCT Number: NCT03616912
• Other Study ID Numbers: 16676; I4V-MC-JAHZ ( Other Identifier: Eli Lilly and Company ); 2017-005026-37 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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.

• Responsible Party: Eli Lilly and Company
• Study Sponsor: Eli Lilly and Company
• Collaborators: Incyte Corporation

Investigators

• 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

• PRS Account: Eli Lilly and Company
• Verification Date: December 2019