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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 : September 21, 2018
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company

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).

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 : February 16, 2021
Estimated Study Completion Date : February 16, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Baricitinib High Dose
Baricitinib administered orally. Placebo administered orally to maintain the blind.
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.
Drug: Placebo
Administered orally.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Percentage of Participants Achieving SRI-4 Response (Low Dose) [ Time Frame: Week 52 ]
    Percentage of participants achieving SRI-4 response (low dose).

  2. Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS) [ Time Frame: Week 52 ]
    Percentage of Participants Achieving a LLDAS.

  3. Time to First Severe Flare [ Time Frame: Baseline to Week 52 ]
    Time to first severe flare.

  4. Change from Baseline in Prednisone Dose [ Time Frame: Baseline, Week 52 ]
    Change from baseline in prednisone dose.

  5. Change from Baseline in Worst Pain Numeric Rating Scale (NRS) [ Time Frame: Baseline, Week 52 ]
    Change from baseline in worst pain NRS.

  6. 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.

  7. 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.

  8. Change from Baseline in Tender Joint Count [ Time Frame: Baseline, Week 52 ]
    Change from baseline in tender joint count.

  9. Change from Baseline in Swollen Joint Count [ Time Frame: Baseline, Week 52 ]
    Change from baseline in swollen joint count.

  10. 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).

  11. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT03616912


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

  Hide Study Locations
Locations
United States, Alabama
Achieve Clinical Research, LLC Not yet recruiting
Birmingham, Alabama, United States, 35216
Contact    205-757-8212      
Principal Investigator: Hayes T Williams         
United States, Arizona
Arizona Arthritis & Rheumatology Research Not yet recruiting
Glendale, Arizona, United States, 85306
Contact    480-626-6650      
Principal Investigator: Saima Chohan         
United States, California
ST Joseph Heritage Medical Group Not yet recruiting
Fullerton, California, United States, 92835
Contact    714-626-8610      
Principal Investigator: Shirley W Pang         
Univ of Southern California Medical Center Not yet recruiting
Los Angeles, California, United States, 90033
Contact    323-442-1946      
Principal Investigator: William Stohl         
UCLA Medical Center Not yet recruiting
Los Angeles, California, United States, 90095
Contact    310-206-3244      
Principal Investigator: Jennifer M Grossman         
United States, Connecticut
New England Research Associates Not yet recruiting
Bridgeport, Connecticut, United States, 06606
Contact    203-325-8529      
Principal Investigator: Geoffrey S Gladstein         
United States, Florida
Lakes Research, LLC Not yet recruiting
Miami Lakes, Florida, United States, 33014
Contact    305-362-4979      
Principal Investigator: Benedicto Fernandez         
New Horizon Research Center Not yet recruiting
Miami, Florida, United States, 33175
Contact    305-226-3933      
Principal Investigator: Francisco G Miranda         
United States, Georgia
Piedmont Healthcare Not yet recruiting
Atlanta, Georgia, United States, 30318
Contact    404-350-0009      
Principal Investigator: Wambui L Machua         
Atlanta Center for Clinical Research Not yet recruiting
Atlanta, Georgia, United States, 30342
Contact    770-226-8819      
Principal Investigator: Stuart Handelsman         
United States, Idaho
St Luke's Clinic - Intermountain Orthopaedics Not yet recruiting
Boise, Idaho, United States, 83702
Contact    208-489-4369      
Principal Investigator: Achini Dingman         
United States, Kentucky
DermResearch, PLLC Not yet recruiting
Louisville, Kentucky, United States, 40217
Contact    502-456-2783      
Principal Investigator: Leon H Kircik         
United States, Maryland
The Center for Rheumatology and Bone Research Not yet recruiting
Wheaton, Maryland, United States, 20902
Contact    301-942-6610      
Principal Investigator: Paul J DeMarco         
United States, Michigan
Henry Ford Health System Not yet recruiting
Detroit, Michigan, United States, 48202
Contact    412-648-4701      
Principal Investigator: Kathleen M Maksimowicz-McKinnon         
United States, Missouri
Clayton Medical Research Recruiting
Saint Louis, Missouri, United States, 63117
Contact    314-646-0688      
Principal Investigator: John J. Budd         
United States, Nevada
Allied Clinical Research Not yet recruiting
Reno, Nevada, United States, 89519
Contact    775-313-9800      
Principal Investigator: Bryan J Wolf         
United States, New Mexico
Albuquerque Rehabilitation & Rheumatology, PC Not yet recruiting
Albuquerque, New Mexico, United States, 87102
Contact    505-341-4148      
Principal Investigator: Leroy A Pacheco         
United States, New York
Northwell Health Not yet recruiting
Great Neck, New York, United States, 11021
Contact    5164706901      
Principal Investigator: Richard Alan Furie         
The Feinstein Institute for Medical Research Not yet recruiting
Manhasset, New York, United States, 11030
Contact    5165623838      
Principal Investigator: Meggan Claire Mackay         
Columbia University Medical Center Not yet recruiting
New York, New York, United States, 10032
Contact    212-305-0856      
Principal Investigator: Anca Askanase         
Buffalo Rheumatology Not yet recruiting
Orchard Park, New York, United States, 14127
Principal Investigator: Joseph Michael Grisanti         
United States, Ohio
Paramount Medical Research Not yet recruiting
Middleburg Heights, Ohio, United States, 44130
Contact    440-891-9395      
Principal Investigator: Isam A. Diab         
United States, Oklahoma
Arthritis & Rheumatology Center of Oklahoma PLLC Not yet recruiting
Oklahoma City, Oklahoma, United States, 73102
Contact    405-606-8730      
Principal Investigator: Mohammad Khan         
United States, Pennsylvania
UPMC Lupus Center of Excellence Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact    412-648-9782      
Principal Investigator: Ghaith Noaiseh         
United States, Texas
Amarillo Center for Clinical Research Not yet recruiting
Amarillo, Texas, United States, 79124
Contact    806-352-2453      
Principal Investigator: Constantine K Saadeh         
Austin Regional Clinic Not yet recruiting
Austin, Texas, United States, 78731
Contact    737-247-7240      
Principal Investigator: Anu Chadha         
Accurate Clinical Management LLC - BayTown Not yet recruiting
Baytown, Texas, United States, 77521
Contact    281-851-7088      
Principal Investigator: Sabeen Najam         
Rheumatology Center of Houston Not yet recruiting
Houston, Texas, United States, 77004
Contact    281-481-8557      
Principal Investigator: Jacqueline D Vo         
United States, Washington
Swedish Medical Center Not yet recruiting
Seattle, Washington, United States, 98122
Contact    206-386-2000      
Principal Investigator: Philip J Mease         
Sponsors and Collaborators
Eli Lilly and Company
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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03616912     History of Changes
Other Study ID Numbers: 16676
I4V-MC-JAHZ ( Other Identifier: Eli Lilly and Company )
2017-005026-37 ( EudraCT Number )
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 17, 2018
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

Keywords provided by Eli Lilly and Company:
SLE

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases