Baricitinib for Alopecia Areata

(BRAVE-AA1 Trial)

No longer recruiting at 138 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

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. ^{1 2 3 4 5}

Why 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. ^{3 4 6 7 8}

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

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

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.

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 for a Trial Participant

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

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?

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

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

Group II: 4 mg Baricitinib Phase 3 Experimental Treatment 2 Interventions

Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.

Group III: 4 Milligram (mg) Baricitinib Phase 2 Experimental Treatment 2 Interventions

Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) and two placebo tablets (QD) administered orally to maintain the blind.

Group IV: 2 mg Baricitinib Phase 3 Experimental Treatment 2 Interventions

Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.

Group V: 2 mg Baricitinib Phase 2 Experimental Treatment 2 Interventions

Participants received one 2 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.

Group VI: 1 mg Baricitinib Phase 2 Experimental Treatment 2 Interventions

Participants received one 1 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.

Group VII: Placebo Phase 3 Placebo Group 1 Intervention

Participants received two placebo tablets administered orally QD.

Group VIII: Placebo Phase 2 Placebo Group 1 Intervention

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:

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40985491/

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).

2. olumiant.lilly.com olumiant.lilly.com/alopecia-areata/olumiant-results

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 ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2110343

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.

4. naaf.org naaf.org/olumiant-baricitinib-faq/

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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03899259

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.

6. olumiant.lilly.com olumiant.lilly.com/hcp/alopecia-areata/safety

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®.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40214720/

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), ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/207924s007lbl.pdf

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) ...