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

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

Tracking Information
First Submitted Date  ICMJE August 1, 2018
First Posted Date  ICMJE August 6, 2018
Last Update Posted Date December 4, 2019
Actual Study Start Date  ICMJE August 2, 2018
Estimated Primary Completion Date May 21, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT03616912 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE
  • Drug: Baricitinib
    Administered orally.
    Other Name: LY3009104
  • Drug: Placebo
    Administered orally.
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 1, 2018)
750
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 21, 2021
Estimated Primary Completion Date May 21, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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  ICMJE 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  ICMJE NCT03616912
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE Eli Lilly and Company
Collaborators  ICMJE Incyte Corporation
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP