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

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ClinicalTrials.gov Identifier: NCT03570749
Recruitment Status : Recruiting
First Posted : June 27, 2018
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: Baricitinib Drug: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 725 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 24, 2018
Estimated Primary Completion Date : April 13, 2021
Estimated Study Completion Date : March 25, 2022

Resource links provided by the National Library of Medicine


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 Alopecia Areata Investigator Global Assessment (AA-IGA™) 0 or 1 with a ≥2 Point Improvement [ Time Frame: Week 36 ]
    Percentage of participants achieving AA-IGA™ 0 or 1 with a ≥2 point improvement


Secondary Outcome Measures :
  1. Percentage of Participants Achieving 75% Improvement of Severity of Alopecia Tool (SALT75) [ Time Frame: Week 36 ]
    Percentage of participants achieving SALT75

  2. 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

  3. Percent Change from Baseline in SALT Score [ Time Frame: Baseline, Week 36 ]
    Percent change from baseline in SALT score

  4. Time for Participants to Achieve AA-IGA™ 0 or 1 with a ≥2 Point Improvement [ Time Frame: Baseline through Week 36 ]
    Time for participants to achieve AA-IGA™ 0 or 1 with a ≥2 point improvement

  5. 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)

  6. 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)

  7. 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)

  8. 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)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

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): NCT03570749


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

  Show 69 Study Locations
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: NCT03570749     History of Changes
Other Study ID Numbers: 16582
I4V-MC-JAHO ( Other Identifier: Eli Lilly and Company )
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 1, 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

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical