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A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata (BRAVE-AA1)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03570749
Recruitment Status : Active, not recruiting
First Posted : June 27, 2018
Last Update Posted : February 3, 2022
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE June 18, 2018
First Posted Date  ICMJE June 27, 2018
Last Update Posted Date February 3, 2022
Actual Study Start Date  ICMJE September 24, 2018
Actual Primary Completion Date February 2, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2020)
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 [ Time Frame: Week 36 ]
Percentage of Participants Achieving SALT ≤ 20
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2018)
Percentage of Participants Treated with the High Dose Baricitinib Achieving Alopecia Areata Investigator's Global Assessment (AA-IGA™) 0 or 1 with a ≥2 Point Improvement [ Time Frame: Week 36 ]
Percentage of participants treated with the high dose baricitinib achieving AA-IGA™ 0 or 1 with a ≥2 point improvement
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2021)
  • Percentage of Participants Achieving 50% Improvement of SALT (SALT50) [ Time Frame: Week 12 ]
    Percentage of participants achieving SALT50
  • Percentage of Participants with Patient Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 with a ≥2-point improvement from Baseline among participants with a score of ≥3 at Baseline [ Time Frame: Week 36 ]
    Percentage of participants with PRO for scalp hair assessment score of 0 or 1 with a ≥2-point improvement from Baseline among participants with a score of ≥3 at Baseline
  • Percent Change from Baseline in SALT Score [ Time Frame: Baseline, Week 36 ]
    Percent change from baseline in SALT score
  • Time for Participants to Achieve SALT ≤ 20 [ Time Frame: Baseline through Week 36 ]
    Time for Participants to Achieve SALT ≤ 20
  • Percentage of Participants Achieving Clinician Reported Outcome (ClinRO) Measure for EyeBrow (EB) Hair Loss 0 or 1 with ≥2-point improvement from Baseline (Among Participants with ClinRO Measure for EB Hair Loss ≥2 at Baseline) [ Time Frame: Week 36 ]
    Percentage of participants achieving ClinRO measure for EB hair loss 0 or 1 with ≥2-point improvement from Baseline (among participants with ClinRO measure for EB hair loss ≥2 at baseline)
  • Percentage of Participants Achieving ClinRO Measure for Eye Lash (EL) Hair Loss 0 or 1 with ≥2-point improvement from Baseline (Among Participants with ClinRO Measure for EL Hair Loss ≥2 at Baseline) [ Time Frame: Week 36 ]
    Percentage of participants achieving ClinRO measure for EL hair loss 0 or 1 with ≥2-point improvement from Baseline (among participants with ClinRO measure for EL hair loss ≥2 at baseline)
  • Percentage of Participants Achieving PRO Measure for EB 0 or 1 with ≥2-point improvement from Baseline (Among Participants with PRO Measure for EB ≥2 at Baseline) [ Time Frame: Week 36 ]
    Percentage of participants achieving PRO measure for EB 0 or 1 with ≥2-point improvement from Baseline (among participants with PRO measure for EB ≥2 at baseline)
  • Percentage of Participants Achieving PRO Measure for EL 0 or 1 with ≥2-point improvement from Baseline (Among Participants with PRO Measure EL ≥2 at Baseline) [ Time Frame: Week 36 ]
    Percentage of participants achieving PRO measure for EL 0 or 1 with ≥2-point improvement from Baseline (among participants with PRO measure EL ≥2 at baseline)
  • Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score [ Time Frame: Week 36 ]
    Mean Change From Baseline in HADS Anxiety Score
  • Mean Change From Baseline in HADS Depression Score [ Time Frame: Week 36 ]
    Mean Change From Baseline in HADS Depression Score
Original Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2018)
  • Percentage of Participants Treated with the Low Dose Baricitinib Achieving AA-IGA™ 0 or 1 with a ≥2 Point Improvement [ Time Frame: Week 36 ]
    Percentage of participants treated with the low dose baricitinib achieving AA-IGA™ 0 or 1 with a ≥2 point improvement
  • Mean Time for Participants to Achieve AA-IGA™ 0 or 1 with a ≥2 Point Improvement [ Time Frame: Baseline through Week 36 ]
    Mean time for participants to achieve AA-IGA™ 0 or 1 with a ≥2 point improvement
  • Percentage of Participants Achieving 75% Improvement of Severity of Alopecia Tool (SALT75) [ Time Frame: Week 36 ]
    Percentage of participants achieving SALT75
  • Percentage of Participants with Patient Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 [ Time Frame: Week 36 ]
    Percentage of participants with PRO for scalp hair assessment score of 0 or 1
  • Change from Baseline in SALT Score [ Time Frame: Baseline, Week 36 ]
    Change from baseline in SALT score
  • Percentage of Participants Achieving Clinician Reported Outcome (ClinRO) Measure for EyeBrow (EB) Hair Loss 0 or 1 (Among Participants with ClinRO Measure for EB Hair Loss ≥2 at Baseline) [ Time Frame: Week 36 ]
    Percentage of participants achieving ClinRO measure for EB hair loss 0 or 1 (among participants with ClinRO measure for EB hair loss ≥2 at baseline)
  • Percentage of Participants Achieving ClinRO Measure for Eye Lash (EL) Hair Loss 0 or 1 (Among Participants with ClinRO Measure for EL Hair Loss ≥2 at Baseline) [ Time Frame: Week 36 ]
    Percentage of participants achieving ClinRO measure for EL hair loss 0 or 1 (among participants with ClinRO measure for EL hair loss ≥2 at baseline)
  • Percentage of Participants Achieving PRO Measure for EB 0 or 1 (Among Participants with PRO Measure for EB ≥2 at Baseline) [ Time Frame: Week 36 ]
    Percentage of participants achieving PRO measure for EB 0 or 1 (among participants with PRO measure for EB ≥2 at baseline)
  • Percentage of Participants Achieving PRO Measure for EL 0 or 1 (Among Participants with PRO Measure EL ≥2 at Baseline) [ Time Frame: Week 36 ]
    Percentage of participants achieving PRO measure for EL 0 or 1 (among participants with PRO measure EL ≥2 at baseline)
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 Severe or Very Severe Alopecia Areata
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Operationally Seamless, Adaptive Phase 2/3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata
Brief Summary This study is designed to select up to two doses of baricitinib (referred to as low dose and high dose) and assess their efficacy and safety for the treatment of severe or very severe alopecia areata.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alopecia Areata
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 * King B, Ohyama M, Kwon O, Zlotogorski A, Ko J, Mesinkovska NA, Hordinsky M, Dutronc Y, Wu WS, McCollam J, Chiasserini C, Yu G, Stanley S, Holzwarth K, DeLozier AM, Sinclair R; BRAVE-AA Investigators. Two Phase 3 Trials of Baricitinib for Alopecia Areata. N Engl J Med. 2022 May 5;386(18):1687-1699. doi: 10.1056/NEJMoa2110343. Epub 2022 Mar 26.

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 2, 2022)
764
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2018)
725
Estimated Study Completion Date  ICMJE June 24, 2024
Actual Primary Completion Date February 2, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Are at least 18 years and ≤60 years for males (≤70 years of age for females) at the time of informed consent.
  • Have severe or very severe AA, as determined by all of the following:

    • Current AA episode of more than 6 months' duration and hair loss encompassing ≥50% of the scalp, as measured by SALT (AA-IGA of 3 or 4) at screening and baseline.
    • No spontaneous improvement over the past 6 months.
    • Current episode of severe or very severe AA of less than 8 years. Note: participants who have severe or very severe AA for ≥8 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 8 years.
  • Male or nonpregnant, nonbreastfeeding female participants.

Exclusion Criteria:

  • Primarily "diffuse" type of AA.
  • Are currently experiencing other forms of alopecia or any other concomitant conditions that would interfere with evaluations of the effect of study medication on AA.
  • Previously treated with an oral Janus kinase (JAK) inhibitor and had an inadequate response (for example, absence of significant terminal hair growth after at least 12 weeks of treatment).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   Korea, Republic of,   Mexico,   Puerto Rico,   United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT03570749
Other Study ID Numbers  ICMJE 16582
I4V-MC-JAHO ( Other Identifier: Eli Lilly and Company )
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 European Union (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/
Current Responsible Party Eli Lilly and Company
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eli Lilly and Company
Original Study Sponsor  ICMJE Same as current
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 February 2022

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