Amlitelimab for Alopecia Areata

Not currently recruiting at 95 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Must not be taking: Oral JAKi, Topical JAKi

Disqualifiers: Other alopecia, Scalp inflammation, others

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

Compensation: Varies

Number of Visits: 38

Duration: 36 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called amlitelimab for individuals with severe alopecia areata, a condition causing significant hair loss on the scalp. The goal is to determine if this treatment can safely and effectively regrow hair. Participants will receive either the treatment or a placebo, which contains no active treatment. Ideal candidates have experienced severe alopecia areata for more than six months but less than eight years, with hair loss affecting at least half of the scalp. Participants must maintain a consistent hairstyle and hair care routine throughout the study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in alopecia areata treatment.

Do I have to stop taking my current medications for the trial?

The protocol does not specify if you must stop taking your current medications. However, if you have used oral JAK inhibitors or the topical JAK inhibitor ruxolitinib for more than 12 months, you may not be eligible, regardless of any washout period.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that certain treatments must not have been received within specific timeframes, so it's best to discuss your current medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that amlitelimab was well-tolerated in earlier studies. In trials involving patients with alopecia areata (a condition that causes hair loss), the treatment did not raise any new safety concerns. The number of side effects related to the treatment was similar to those seen with a placebo (a harmless, inactive treatment used for comparison). This suggests that amlitelimab is safe for humans and does not cause unexpected side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for alopecia areata, which often include topical corticosteroids or oral medications that suppress the immune system, Amlitelimab offers a novel approach. Amlitelimab is unique because it targets the OX40 ligand, a key player in the immune response associated with this condition, potentially reducing inflammation more precisely. Researchers are excited about Amlitelimab because it is administered via subcutaneous injection, which could offer more convenient, targeted relief with fewer systemic side effects. This targeted mechanism could lead to more effective and safer treatment options for those affected by alopecia areata.

What evidence suggests that amlitelimab might be an effective treatment for alopecia areata?

Research shows that amlitelimab may help with conditions caused by an overactive immune system, such as atopic dermatitis. In studies, it successfully reduced inflammation and improved skin conditions. In this trial, participants will receive either one of two doses of amlitelimab or a placebo. Although specific data for alopecia areata (a condition that causes hair loss) is still being collected, amlitelimab's ability to calm the immune system suggests it might help by stopping the immune attack on hair follicles. Early results are promising for treating alopecia areata, but more research is needed to understand its full effect on hair regrowth. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

Adults with severe alopecia areata (AA) for less than 8 years, no recent hair regrowth, and willing to maintain a consistent hairstyle. They must have lost more than half of their scalp hair. Those with AA for over 8 years can join if they've had some regrowth.

Inclusion Criteria

Willingness to maintain a consistent hair style and hair care, including refraining from certain practices like weaves, extensions, and shaving of scalp hair for 2 weeks prior to each study visit

I have been diagnosed with alopecia areata for over 6 months.

I have severe alopecia areata with over half my scalp losing hair for less than 8 years without hair regrowth in the last 6 months.

Exclusion Criteria

I will wait for my hair to grow back before joining the study.

Participants who received specified treatment regimens within the outlined timeframe in the protocol

I have used oral or topical JAK inhibitors for over a year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous injections of amlitelimab or placebo during the double-blind period

36 weeks

12 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Open-label extension (optional)

Participants may opt into continuation of amlitelimab treatment long-term

104 weeks

26 visits

What Are the Treatments Tested in This Trial?

Interventions

• Amlitelimab

Trial Overview The trial is testing Amlitelimab injections against a placebo in adults with severe AA. It's double-blind, meaning neither the participants nor the researchers know who gets the real treatment or placebo until after the study.

How Is the Trial Designed?

Group I: Amlitelimab dose group 2 Experimental Treatment 1 Intervention

Subcutaneous injection as per protocol

Group II: Amlitelimab dose group 1 Experimental Treatment 1 Intervention

Subcutaneous injection as per protocol

Group III: Placebo Placebo Group 1 Intervention

Subcutaneous injection as per protocol

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Published Research Related to This Trial

In a pilot study involving 30 patients with moderate-to-severe alopecia areata, apremilast did not show a significant improvement in hair regrowth compared to placebo, with only 1 patient in each group achieving a 50% reduction in severity after 24 weeks.

The results suggest that targeting the PDE4 pathway with apremilast may not be effective for moderate-to-severe alopecia areata, but it could still be worth exploring in patients with milder forms of the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized placebo-controlled single-center pilot study of the safety and efficacy of apremilast in subjects with moderate-to-severe alopecia areata. Mikhaylov, D., Pavel, A., Yao, C., et al.[2019]

In a study involving eight women with very severe alopecia areata, the combination of baricitinib (4 mg) and prednisone (20 mg) resulted in complete hair regrowth for seven out of eight participants, demonstrating high efficacy for this difficult-to-treat condition.

This combination therapy shows promise as a well-tolerated treatment option for very severe alopecia areata, where traditional treatments like baricitinib or methotrexate alone have been ineffective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Major improvement of very severe alopecia areata in patients treated with the combination of baricitinib and low doses of corticosteroids: an eight-case series. Hébert, V., Joly, P.[2023]

In a pilot study involving 12 patients with moderate-to-severe alopecia areata, 75% experienced significant hair regrowth (average of 92%) after treatment with the oral JAK1/2 inhibitor ruxolitinib for 3-6 months.

The treatment was well-tolerated with no serious adverse effects reported, and gene expression analysis indicated a reduction in inflammatory markers associated with the disease, suggesting a mechanism of action that targets the autoimmune response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral ruxolitinib induces hair regrowth in patients with moderate-to-severe alopecia areata. Mackay-Wiggan, J., Jabbari, A., Nguyen, N., et al.[2023]

In the phase 2a ALLEGRO trial involving 142 adults with alopecia areata, both ritlecitinib and brepocitinib significantly improved patient-reported outcomes (AASIS scores) and clinician-assessed hair loss (SALT scores) after 24 weeks compared to placebo.

The study found medium-to-large correlations between patient-reported outcomes and clinician assessments, indicating that both measures are important for evaluating treatment effectiveness in alopecia areata.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing the relationships between patient-reported outcomes and clinician assessments of alopecia areata in a phase 2a randomized trial of ritlecitinib and brepocitinib. Winnette, R., Banerjee, A., Sikirica, V., et al.[2022]

In the ALLEGRO phase 2b/3 study involving patients aged 12 and older with at least 50% scalp hair loss, ritlecitinib demonstrated significant efficacy in improving hair regrowth compared to placebo, regardless of distinct hair loss profiles identified at baseline.

Five distinct hair loss profiles were identified, and patients receiving ritlecitinib at doses of 30 mg or 50 mg were significantly more likely to report positive changes in hair growth and satisfaction with hair regrowth at 24 weeks, indicating the treatment's effectiveness across different types of alopecia areata.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hair Loss Profiles and Ritlecitinib Efficacy in Patients with Alopecia Areata: Post Hoc Analysis of the ALLEGRO Phase 2b/3 Study. Thaçi, D., Tziotzios, C., Ito, T., et al.[2023]

A 33-year-old man with alopecia totalis, who had not responded well to previous treatments, experienced complete beard regrowth after 4 months of treatment with ruxolitinib, a Janus kinase (JAK) inhibitor.

This case demonstrates the potential of JAK inhibitors as an effective therapy for severe alopecia areata, particularly in individuals for whom hair loss has significant cultural and psychological implications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complete Regrowth of Beard Hair with Ruxolitinib in an Alopecia Universalis Patient. Ramot, Y., Zlotogorski, A.[2020]

Tofacitinib, a small molecule JAK inhibitor, showed promising results in treating moderate to severe alopecia areata (AA) in a trial with 12 patients, where 8 patients experienced at least 50% hair regrowth after treatment.

The treatment was generally safe, with minimal adverse events reported, and the study supports the potential for larger clinical trials to further explore JAK inhibitors as a viable option for AA management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Open-Label Pilot Study to Evaluate the Efficacy of Tofacitinib in Moderate to Severe Patch-Type Alopecia Areata, Totalis, and Universalis. Jabbari, A., Sansaricq, F., Cerise, J., et al.[2023]

Baricitinib, the first FDA-approved treatment for alopecia areata, showed significant efficacy in two phase III trials, with 38.8% of patients achieving a Severity of Alopecia Tool score of 20 or less at a 4 mg dose compared to only 6.2% in the placebo group (P<0.001).

While baricitinib is generally well-tolerated, it carries black-box warnings due to potential adverse effects, which were mostly mild to moderate, including acne and cholesterol elevation, indicating it is a relatively safe option for treating severe alopecia areata.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Baricitinib in the Treatment of Alopecia Areata. Singh, R., Driscoll, MS.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06444451

NCT06444451 | A Study to Evaluate the Efficacy and ... A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata.

2. sanofi.com sanofi.com/en/media-room/press-releases/2025/2025-09-04-05-00-00-3144170

Press Release: Sanofi's amlitelimab met all primary and ... Sanofi's amlitelimab met all primary and key secondary endpoints in the COAST 1 phase 3 study in adults and adolescents with atopic ...

3. naaf.org naaf.org/studies/sanofi_amlitelimab_aa/

Study to Evaluate the Efficacy and Safety of Subcutaneous ... Study to evaluate the efficacy and safety of subcutaneous amlitelimab monotherapy compared with placebo in adult participants with severe alopecia areata.

4. jaad.org jaad.org/article/S0190-9622(23)02242-9/pdf

41343 Safety of Amlitelimab in a Phase 2a Clinical Trial of ... Tirbanibulin ointment 1% has demonstrated efficacy, tolerability, and safety for AKs, and is approved in the US and Europe for treating AK on the face or scalp ...

5. clinicaltrials.icts.uci.edu clinicaltrials.icts.uci.edu/trial/NCT06444451

Subcutaneous Amlitelimab Monotherapy Compared With ... Stable disease: no evidence of terminal hair regrowth within 6 months (less than 10% improvement over the past 6 months). (guidance: if participant reports to ...