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

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Brief Title

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

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

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).
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Percentage of Participants Achieving Alopecia Areata Investigator Global Assessment (AA-IGA™) 0 or 1 with a ≥2 Point Improvement

Secondary Outcome

 Percent Change from Baseline in Severity of Alopecia Tool (SALT) Score

Condition

Alopecia Areata

Intervention

Baricitinib

Study Arms / Comparison Groups

 Baricitinib High Dose
Description:  Baricitinib administered orally. Placebo administered orally to maintain the blind.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

476

Start Date

July 8, 2019

Completion Date

February 8, 2023

Primary Completion Date

February 5, 2021

Eligibility 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).
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

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), 1-317-615-4559, [email protected]

Location Countries

Argentina

Location Countries

Argentina

Administrative Informations


NCT ID

NCT03899259

Organization ID

16978

Secondary IDs

I4V-MC-JAIR

Responsible Party

Sponsor

Study Sponsor

Eli Lilly and Company

Collaborators

 Incyte Corporation

Study Sponsor

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), Study Director, Eli Lilly and Company


Verification Date

June 15, 2020