A study to evaluate the efficacy and safety of subcutaneous amlitelimab monotherapy compared with placebo in adult participants with severe alopecia areata
EU CTIS ID: 2024-511225-64-00
What this study is testing
To evaluate the efficacy of amlitelimab compared to placebo in adult participants with AA with 50% or greater scalp hair loss on regrowth of lost hair
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Definitive diagnosis of AA of more than 6 months.
- Diagnosis of severe AA, as determined by all of the following: a) Hair loss affecting ≥50% of the scalp, as measured by Severity of Alopecia Tool (SALT) at both screening and baseline visits. b) Current episode of severe hair loss of less than 8 years. Participants with a history of AA of more than 8 years who have observed episodes of terminal hair regrowth over their scalp (“moving patches” spontaneously or following treatment) in the past 8 years can be included. c) Stable disease: no evidence of terminal hair regrowth within 6 months (ie, equivalent to less than 10% improvement points spontaneous reduction in SALT over the past 6 months). (guidance: if participant reports to have quite a bit more hair than 6 months prior, then patient cannot be included).
- Willingness in maintaining a consistent hair style and hair care, including hair products, and to refrain from weaves, extensions, adhesive wigs, other than banded perimeter devices, refrain from shaving of scalp hair for 2 weeks prior to each study visit from baseline to the EOS.
You likely can't join if
- Participants that are currently experiencing other forms of alopecia, including but not limited to: androgenetic alopecia, trichotillomania, telogen effluvium, traction alopecia, scarring alopecia.
- Participants currently with any local or systemic active medical conditions which in the opinion of the Investigator would interfere with evaluations of the IMP effect on AA due to scalp inflammation, including but not limited to seborrheic dermatitis requiring topical treatment to the scalp, lupus erythematosus, lichen planus, psoriasis, secondary syphilis, tinea capitis, thyroiditis, systemic sclerosis, hair transplants, micropigmentation/tattoo of the scalp
- Received the specified treatment regimens within the timeframe outlined in the protocol.
- Prior use of any oral JAKi or the topical JAKi ruxolitinib for more than 24 months, regardless if washout period is respected.
- Subjects with shaved heads must not enter the study until hair has grown back and SALT score can be reliably administered.
The study team makes the final eligibility decision.
Where it's taking place
- Chile
- United Kingdom
- Australia
- Argentina
- China
- United States
- Japan
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chile; United Kingdom; Australia; Argentina; China; United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.