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

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Clinico San Carlos	Madrid	Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Spitalul Clinic Judetean De Urgenta Cluj	Cluj Napoca	Romania
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Hautarztpraxis Dr. Mihaescu	Augsburg	Germany

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Praglandia s.r.o.	Prague	Czechia
Hospital Universitario Infanta Leonor	Madrid	Spain
CCR Ostrava s.r.o.	Moravska Ostrava A Privoz	Czechia
Ospedale San Raffaele S.r.l.	Milan	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Eurofins bioskin GmbH	Hamburg	Germany
Centre Hospitalier Universitaire De Nice	Nice	France
Klinische Forschung Osnabrueck	Osnabrück	Germany
Medical Center Comac Medical Ltd.	Sofia	Bulgaria
Centre SABOURAUD	Paris	France
Teqeonhnzcb unu Snscjspbnru Bgndanbs Gpcj	Bad Bentheim	Germany
Sxmnadzm Cb sxqzbj	Prague	Czechia
Ernsiyz Urlaeygtmcnm Mkorkbq Clmhcvh Rripoufmi (gfxplhu Mfq	Rotterdam	The Netherlands
Urkzewalqcwgoordzdsin Mjqgscos Atz	Munster	Germany
Apusffz Uxwpc Sntptwojh Lupwlw Dj Bvqyunp	Bologna	Italy
Hwrlpshu Vccf dzqkzsfz	Barcelona	Spain
Fcnaacpgvf Gmxi	Offenbach Am Main	Germany

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	01.09.2024
Czechia	Not recruiting	01.09.2024
France	Not recruiting	01.09.2024
Germany	Not recruiting	01.09.2024
Italy	Not recruiting	01.09.2024
Romania	Not recruiting	01.09.2024
Spain	Not recruiting	01.09.2024
The Netherlands	Not recruiting	01.09.2024

Trial locations

Investigated drugs:

Amlitelimab

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.

Investigated diseases:

Alopecia areata

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 ID:

2024-511225-64-00

Protocol code:

DRI18180

NCT ID:

NCT06444451

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

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