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A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE) (SLE-BRAVE-X)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03843125
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE February 14, 2019
First Posted Date  ICMJE February 15, 2019
Last Update Posted Date July 7, 2020
Actual Study Start Date  ICMJE September 9, 2019
Estimated Primary Completion Date May 30, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2019)
  • Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline through Week 156 ]
    Percentage of participants with TEAEs
  • Percentage of Participants with Adverse Events of Special Interest (AESIs) [ Time Frame: Baseline through Week 156 ]
    Percentage of Participants with AESIs
  • Percentage of Participants with Serious Adverse Events (SAEs) [ Time Frame: Baseline through Week 156 ]
    Percentage of participants with SAEs
  • Percentage of Participants with Temporary Investigational Product Interruptions [ Time Frame: Baseline through Week 156 ]
    Percentage of participants with temporary investigational product interruptions
  • Percentage of Participants with Permanent Investigational Product Discontinuations [ Time Frame: Baseline through Week 156 ]
    Percentage of participants with permanent investigational product discontinuations
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2019)
  • Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response [ Time Frame: Week 156 ]
    Percentage of participants achieving SRI-4 response
  • Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS) [ Time Frame: Week 156 ]
    Percentage of participants achieving a LLDAS
  • Change from Baseline in Prednisone Dose [ Time Frame: Baseline, Week 156 ]
    Change from baseline in prednisone dose
  • Annualized Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index Flare Rate [ Time Frame: Baseline through Week 156 ]
    Annualized SELENA-SLEDAI flare index flare rate
  • 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 156 ]
    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 156 ]
    Change from baseline in tender joint count
  • Change from Baseline in Swollen Joint Count [ Time Frame: Baseline, Week 156 ]
    Change from baseline in swollen joint count
  • Change from Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Total Score [ Time Frame: Baseline, Week 156 ]
    Change from baseline in SLICC/ACR damage index total score
  • Change from Baseline in Worst Pain Numeric Rating Scale (NRS) [ Time Frame: Baseline, Week 156 ]
    Change from baseline in worst pain NRS
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 in Participants With Systemic Lupus Erythematosus (SLE)
Official Title  ICMJE A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)
Brief Summary The reason for this long term study is to see how safe and effective the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE) who have completed the final treatment visit of study I4V-MC-JAHZ (NCT03616912) or study I4V-MC-JAIA (NCT03616964).
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
Study Arms  ICMJE
  • Experimental: Baricitinib High Dose
    Baricitinib administered orally.
    Intervention: Drug: Baricitinib
  • Experimental: Baricitinib Low Dose
    Baricitinib administered orally.
    Intervention: Drug: Baricitinib
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: February 14, 2019)
1100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2025
Estimated Primary Completion Date May 30, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have completed the final treatment study visit of an originating study, such as study JAHZ (NCT03616912) or Study JAIA (NCT03616964).
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 multiples 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 Argentina,   Australia,   Austria,   Belgium,   Brazil,   Chile,   China,   Colombia,   Croatia,   Czechia,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Philippines,   Poland,   Romania,   Russian Federation,   Serbia,   South Africa,   Spain,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03843125
Other Study ID Numbers  ICMJE 16832
I4V-MC-JAIM ( Other Identifier: Eli Lilly and Company )
2017-005028-11 ( 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: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
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 July 1, 2020

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