Baricitinib for Alopecia Areata
(BRAVE-AA1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests different doses of baricitinib to evaluate its effectiveness for individuals with severe or very severe alopecia areata, a condition causing large patches of hair loss on the scalp. Researchers aim to determine if baricitinib can regrow hair and assess its safety. The study includes several groups, with some participants receiving a placebo (a pill with no medicine) to compare results. Individuals with severe hair loss for more than six months, showing no signs of improvement, might be suitable for this trial. As a Phase 2, Phase 3 trial, this study measures the treatment's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to important research.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that baricitinib has been tested for safety in people with severe alopecia areata, a condition that causes hair loss. Studies have found that baricitinib is generally well-tolerated. Common side effects include headaches, higher cholesterol levels, and colds. Serious side effects are less common but can include blood clots or infections.
Trials compared baricitinib to a placebo, a pill with no active ingredients. Most patients taking baricitinib did not stop treatment due to side effects, indicating it is well-tolerated for most people. Discussing potential risks with a healthcare provider is important.12345Why are researchers excited about this trial's treatments?
Baricitinib is unique because it targets the Janus kinase (JAK) pathway, which plays a key role in the immune response that contributes to alopecia areata. Most current treatments for this condition, like corticosteroids or topical immunotherapy, mainly focus on suppressing inflammation or stimulating hair growth without directly addressing the underlying immune mechanisms. Researchers are excited about baricitinib because its targeted approach could offer more effective management of alopecia areata with potentially fewer side effects. Additionally, the oral administration of baricitinib provides a convenient alternative to topical or injectable treatments, making it a promising option for patients.
What evidence suggests that this trial's treatments could be effective for alopecia areata?
Research has shown that baricitinib can help treat severe alopecia areata, a condition that causes hair loss. In some studies, up to 63% of patients experienced significant hair regrowth on their scalp after 48 weeks, while more than 75% saw moderate regrowth. Additionally, in certain trials, 24-26% of patients taking a 4 mg dose had 90% or more of their hair grow back after 36 weeks. Participants in this trial may receive different doses of baricitinib, including 1 mg, 2 mg, or 4 mg, or a placebo. Overall, baricitinib has proven more effective than a placebo in helping people with severe alopecia areata regrow their hair.34678
Who Is on the 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
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either low dose or high dose of Baricitinib or placebo for the treatment of severe or very severe alopecia areata
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
An additional subpopulation of 60 participants in the US will enroll in the open-label addenda to continue receiving Baricitinib
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
Baricitinib will be administered orally during the open-label addenda.
Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) and two placebo tablets (QD) administered orally to maintain the blind.
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
Participants received one 2 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.
Participants received one 1 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.
Participants received two placebo tablets administered orally QD.
Participants received three placebo tablets administered orally QD to maintain the blind.
Baricitinib is already approved in United States, European Union for the following indications:
- Rheumatoid arthritis
- Severe alopecia areata
- COVID-19
- Rheumatoid arthritis
- Severe alopecia areata
- COVID-19
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
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
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
Citations
Effectiveness and safety of baricitinib in severe alopecia ...
Key findings: After 48 weeks, 63% of patients had major scalp hair regrowth (SALT ≤20), and over 75% had moderate regrowth (SALT ≤30).
Olumiant® Results in Alopecia Areata
In clinical studies, some adults with severe alopecia areata taking Olumiant achieved 80% scalp hair coverage at 36 weeks. ... Up to 22% of people taking 2 mg ...
Two Phase 3 Trials of Baricitinib for Alopecia Areata
In two phase 3 trials involving patients with severe alopecia areata, oral baricitinib was superior to placebo with respect to hair regrowth at 36 weeks.
Olumiant (baricitinib) FAQ
In addition, 24-26% of patients taking 4mg per day of Olumiant achieved 90% or more hair coverage after 36 weeks of treatment (6). What are the most common side ...
NCT03899259 | A Study of Baricitinib (LY3009104) in ...
Clinical Outcomes for Uptitration of Baricitinib Therapy in Patients With Severe Alopecia Areata: A Pooled Analysis of the BRAVE-AA1 and BRAVE-AA2 Trials.
Safety | Alopecia Areata | Olumiant® (baricitinib) - Eli Lilly
Find safety information for adult patients with severe Alopecia Areata (AA), including clinical trial data and potential adverse reactions of Olumiant®.
Safety of Baricitinib in Adults with Severe Alopecia Areata ...
Background: We report pooled safety data for baricitinib treatment of severe alopecia areata in patients in BRAVE-AA1 (phase II/III) and BRAVE-AA2 (phase III), ...
OLUMIANT (baricitinib) tablets, for oral use - accessdata.fda.gov
The safety of OLUMIANT was evaluated in two placebo-controlled trials in patients with severe alopecia areata. Patients were randomized to placebo (371 patients) ...
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