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Study of amlitelimab injection compared to placebo for adults with severe alopecia areata (hair loss)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on alopecia areata, a condition that causes severe hair loss on the scalp. The research evaluates a new medication called amlitelimab, which is given as an injection under the skin (subcutaneous injection). The purpose is to determine how well amlitelimab works in helping regrow hair in adults who have lost 50% or more of their scalp hair.

The study compares amlitelimab to placebo in people with severe hair loss that has lasted more than 6 months. The treatment involves receiving injections over a period of 36 weeks. The medication comes in the form of a solution for injection in pre-filled syringe, making it easier to administer.

During the study, doctors will measure how much hair grows back on participants' scalps. They will also look at hair regrowth in eyebrows and eyelashes, and monitor how participants feel about their improvement. The study will track any side effects that may occur during the treatment period to ensure the medication's safety.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial phase

    After qualifying for the study with severe alopecia areata (a condition causing hair loss affecting 50% or more of the scalp), you will begin participation in a 36-week clinical trial.

    You will need to maintain consistent hair care practices and avoid using weaves, extensions, or adhesive wigs throughout the study period.

    Your current hair loss condition must be stable, with no significant hair regrowth in the past 6 months.

  2. Step 2

    Treatment administration

    You will receive either amlitelimab or a placebo (inactive substance) through subcutaneous injection (injection under the skin).

    The medication will be provided in pre-filled syringes for injection.

    The study will compare three different groups of participants to evaluate the effectiveness of the treatment.

  3. Step 3

    24-week assessment

    At week 24, your progress will be evaluated using the Severity of Alopecia Tool (SALT) to measure changes in hair growth.

    Additional assessments will include examination of eyebrow and eyelash hair growth if applicable.

    You will be asked to provide feedback about your perception of hair growth improvements.

  4. Step 4

    Final evaluation

    The final assessment will occur at week 36, measuring the overall change in hair growth using the SALT score.

    The evaluation will include comprehensive documentation of any changes in scalp, eyebrow, and eyelash hair growth.

    Medical staff will record any side effects or reactions experienced during the study period.

Who can join the trial?

11 criteria

  • Must be an adult (18 years or older)
  • Must have a confirmed diagnosis of alopecia areata (a condition causing hair loss) for more than 6 months
  • Must have severe hair loss affecting 50% or more of the scalp, measured by a special assessment tool called SALT (Severity of Alopecia Tool)
  • Current episode of severe hair loss must be less than 8 years in duration
  • If history of condition is longer than 8 years, must have had periods of hair regrowth on scalp ("moving patches") within the past 8 years
  • Must have stable condition with no significant hair regrowth in the past 6 months (less than 10% improvement)
  • Must be willing to:
    • Maintain consistent hair style and hair care routine
    • Avoid using hair weaves and extensions
    • Avoid using adhesive wigs (non-adhesive wigs secured around the edges are allowed)
    • Not shave scalp hair for 2 weeks before study visits
    • Both men and women can participate

Who cannot join the trial?

14 criteria

  • Age below 18 or above 75 years old
  • Current or past treatment with any biologic therapy (medications created from living organisms) for alopecia areata in the last 6 months
  • Use of systemic corticosteroids (oral or injectable medications that reduce inflammation) within 4 weeks before starting the study
  • Active or chronic infections, including tuberculosis, hepatitis B, hepatitis C, or HIV
  • History of cancer within the past 5 years (except successfully treated non-melanoma skin cancer)
  • Significant heart, liver, or kidney disease
  • Pregnant or breastfeeding women
  • Current participation in other clinical trials
  • Known allergies to similar medications
  • Major surgery within 8 weeks before the study starts
  • Unstable medical conditions that could interfere with the study
  • History of substance abuse within the past year
  • Mental health conditions that could affect ability to participate
  • Use of any investigational drugs within 8 weeks or 5 half-lives before the study
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Investigated drugs

  • Amlitelimab

    is a new investigational medication given by injection under the skin (subcutaneously). It is being studied as a potential treatment for severe alopecia areata, an autoimmune condition that causes hair loss. This medication works by targeting the immune system to potentially help regrow hair in people who have lost 50% or more of their scalp hair.

  • Placebo

    is an inactive substance that contains no medication. It is used as a comparison to determine if the active medication is effective. In this trial, it is given as an injection under the skin, similar to the active medication.

What is already known about the treatment

Amlitelimab – A novel investigational monoclonal antibody administered through subcutaneous injection, currently being studied in Phase 2 clinical trials for the treatment of severe alopecia areata, an autoimmune condition causing hair loss. This medication works by targeting specific immune system pathways involved in the hair loss process, aiming to promote hair regrowth in patients with significant scalp hair loss (50% or greater). As a biological therapy, it belongs to the class of immunomodulating agents, and its mechanism of action involves modifying the immune response that leads to hair follicle damage and subsequent hair loss.

Investigated diseases

Alopecia areata - An autoimmune condition where the body's immune system attacks hair follicles, causing hair loss in round or oval patches. The condition typically begins with one or more small, round, smooth patches on the scalp, but can affect any hair-bearing area of the body. Hair loss can occur suddenly, often developing in just a few days or weeks. The condition can affect people of all ages and both genders, with varying patterns of hair loss and regrowth. Some people may experience cycles of hair loss followed by periods of regrowth, while others may develop more extensive hair loss over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511225-64-00Protocol codeDRI18180Estimated enrolment221 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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