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A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata (BRAVE-AA2)

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ClinicalTrials.gov Identifier: NCT03899259
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : August 5, 2019
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 476 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo- Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata
Actual Study Start Date : July 8, 2019
Estimated Primary Completion Date : May 12, 2021
Estimated Study Completion Date : May 30, 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. Percent Change from Baseline in Severity of Alopecia Tool (SALT) Score [ Time Frame: Baseline, Week 12 ]
    Percent change from baseline in SALT score

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

  3. 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

  4. Time to Achieve AA-IGA™ 0 or 1 with a ≥2 Point Improvement [ Time Frame: Baseline through Week 36 ]
    Time 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 Eyelash (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)

  9. Change from Baseline in Skindex-16 AA Symptoms Domain Score [ Time Frame: Baseline, Week 36 ]
    Change from Baseline in Skindex-16 AA Symptoms Domain Score

  10. Change from Baseline in Skindex-16 AA Emotions Domain Score [ Time Frame: Baseline, Week 36 ]
    Change from Baseline in Skindex-16 AA Emotions Domain Score

  11. Change from Baseline in Skindex-16 AA Functioning Domain Score [ Time Frame: Baseline, Week 36 ]
    Change from Baseline in Skindex-16 AA Functioning Domain Score



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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): NCT03899259


Contacts
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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 81 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Incyte Corporation
Investigators
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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:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03899259     History of Changes
Other Study ID Numbers: 16978
I4V-MC-JAIR ( Other Identifier: Eli Lilly and Company )
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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: http://www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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