Baricitinib for Alopecia Areata

(BRAVE-AA1 Trial)

Recruiting at 119 trial locations

Overseen By Valerie Callender

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Eli Lilly and Company

Must not be taking: Oral JAK inhibitors

Disqualifiers: Diffuse alopecia, Other alopecia, others

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 36 weeks

784 Participants Needed

Trial Summary

What is the purpose of this trial?

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. An additional subpopulation of 60 participants in the US will enroll in the open-label addenda.

Research Team

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)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for adults with severe or very severe alopecia areata (AA) who haven't seen hair regrowth in the past 6 months. Participants should have had AA for more than 6 months but less than 8 years, and lost over half their scalp hair. Women must not be pregnant or breastfeeding. People with diffuse AA, other alopecia types, conditions affecting study results, or inadequate response to oral JAK inhibitors are excluded.

Inclusion Criteria

I have had severe hair loss for less than 8 years, or I've seen hair regrowth in the last 8 years if it's been longer.

I am a male aged 18-60 or a female aged 18-70.

Must self-identify as either Black or African American in race in the open label addenda.

Exclusion Criteria

My alopecia areata is mainly of the diffuse type.

I don't have other hair loss conditions affecting the study's evaluation.

I took a JAK inhibitor for over 12 weeks without significant hair growth.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either low dose or high dose of Baricitinib or placebo for the treatment of severe or very severe alopecia areata

36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

An additional subpopulation of 60 participants in the US will enroll in the open-label addenda to continue receiving Baricitinib

Treatment Details

Interventions

• Baricitinib
• Placebo

Trial Overview The trial is testing two doses of Baricitinib against a placebo to see how well they work and how safe they are for treating severe AA. Some participants will join an open-label part where everyone gets Baricitinib without being compared to a placebo.

Participant Groups

Group I: Open-Label Addenda Baricitinib High Dose Experimental Treatment 1 Intervention

Baricitinib will be administered orally during the open-label addenda.

Group II: Baricitinib Low Dose Experimental Treatment 2 Interventions

Baricitinib administered orally. Placebo administered orally to maintain the blind.

Group III: Baricitinib High Dose Experimental Treatment 2 Interventions

Baricitinib administered orally. Placebo administered orally to maintain the blind.

Group IV: Placebo Placebo Group 1 Intervention

Placebo administered orally.

Baricitinib is already approved in United States, European Union for the following indications:

Approved in United States as Olumiant for:

• Rheumatoid arthritis
• Severe alopecia areata
• COVID-19

Approved in European Union as Olumiant for:

• Rheumatoid arthritis
• Severe alopecia areata
• COVID-19

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Incyte Corporation

Industry Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School