Active not recruitingPHASE2INTERVENTIONAL

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

This study is testing a new medicine called amlitelimab for adults who have severe alopecia areata, a condition causing significant hair loss. The main goal is to find out if this new medicine is safe and if it helps hair regrow. Participants will be split into groups; some will receive amlitelimab, and others will get a placebo (a dummy treatment with no active medicine). This comparison helps researchers understand if the new medicine is actually working. The study is "double-blind," meaning neither the patients nor their doctors will know who is getting the real medicine. It's a key step to see if amlitelimab could become a new treatment option for severe alopecia areata.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Sanofi

Enrolment target

166

Start

06 Jun 2024

Estimated completion

05 Jan 2028

Alopecia Areata

What is this study about?

This research study is about a new medicine called amlitelimab, and its potential to help people with severe alopecia areata. Alopecia areata is a condition where your immune system mistakenly attacks your hair follicles, leading to patches of hair loss, or in severe cases, loss of most or all scalp hair.

The study aims to understand two main things: first, if amlitelimab is safe to use, meaning it doesn't cause too many serious side effects. Second, it wants to see if the medicine is effective at encouraging hair regrowth in people who have lost a lot of their hair due to severe alopecia areata. By comparing the new medicine to a placebo (a treatment that looks the same but contains no active medicine), the scientists can get a clearer picture of whether amlitelimab is truly making a difference.

Finding new treatments for severe alopecia areata is very important because it can have a big impact on people's lives. If this study shows positive results, amlitelimab could eventually offer a new option for people living with this condition.

Key takeaways

Tests a new medicine (amlitelimab) for severe alopecia areata.
Compares the new medicine to a dummy treatment (placebo).
Study lasts up to 3 years and 4 months, including follow-up.
You will not know if you're getting the active medicine or placebo initially.
Aims to find out if amlitelimab is safe and effective for hair regrowth.
Participation involves regular clinic visits for assessments and injections.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with alopecia areata for at least six months. You need to have severe hair loss, meaning 50% or more of your scalp is affected, and this current hair loss episode should have started less than eight years ago. Your hair loss should also be stable, meaning you haven't seen a lot of new hair growth recently.

There are also some important reasons why you might not be able to join. For example, if you have other types of hair loss, such as male or female pattern baldness, or if you have certain other skin conditions like psoriasis or lupus that affect the scalp. Also, if you've recently used certain strong medications for your hair or immune system, you might not be able to take part.

To make sure the study results are clear, you'll need to be happy to keep a consistent hairstyle and hair care routine throughout the study. This includes avoiding certain hair treatments like weaves, extensions, or shaving your scalp before visits.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with alopecia areata for at least 6 months?
Do you have severe hair loss (at least 50% of your scalp)?
Did your current severe hair loss episode start less than 8 years ago?
Are you willing to keep a consistent hairstyle and hair care routine?
Do you have other types of hair loss (e.g., male/female pattern baldness)? (If yes, you may not be eligible)
Do you have other significant skin conditions on your scalp like psoriasis or lupus? (If yes, you may not be eligible)

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll first have a screening period that lasts about 2 to 4 weeks. After that, you'll enter the first main part of the study, which lasts 36 weeks. During this time, you'll either receive the study medicine (amlitelimab) or a dummy treatment (placebo) through injections under your skin. Neither you nor your study doctor will know which one you're getting.

After these 36 weeks, if you wish, you might be able to join an optional 'open-label' period for another 104 weeks. In this part, everyone who joins will receive the actual study medicine. Once all treatment periods are over, there will be a 16-week safety follow-up. In total, the study could last up to 160 weeks (about three years).

You will need to attend up to 38 visits to the study clinic if you join the optional longer period. If you only complete the first 36-week part, you would have around 12 visits. During these visits, the study team will check your health, assess your hair loss, and see how you're responding to the treatment.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of joining this study is that you might receive access to a new medicine that could help your severe alopecia areata before it's widely available. You'll also be closely monitored by medical professionals. However, there's no guarantee that the medicine will work for you, and you might receive the placebo. There could be side effects from the study medicine, some of which might not be known yet. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (74)

Total Skin and Beauty Dermatology Center- Site Number : 8400018
Birmingham, United States
First OC Dermatology- Site Number : 8400014
Fountain Valley, United States
Center for Dermatology Clinical Research- Site Number : 8400008
Fremont, United States
UC Irvine Healthcare - Gottschalk Medical Plaza- Site Number : 8400007
Irvine, United States
Dermatology Research Associates - Los Angeles- Site Number : 8400015
Los Angeles, United States
New Horizon Research Center- Site Number : 8400017
Miami, United States
Dawes Fretzin Clinical Research- Site Number : 8400010
Indianapolis, United States
Michigan Center for Research Company- Site Number : 8400016
Clarkston, United States
Joel Schlessinger, PC- Site Number : 8400021
Omaha, United States
Icahn School of Medicine at Mount Sinai- Site Number : 8400003
New York, United States
DJL Clinical Research - Charlotte - Park Road- Site Number : 8400013
Charlotte, United States
Cleveland Clinic- Site Number : 8400028
Cleveland, United States

+62 more sites — see the official record for the full list.

Common questions

What is alopecia areata?

Alopecia areata is a condition where your immune system attacks your hair follicles, causing hair loss on the scalp and sometimes other parts of the body.

What is a 'placebo'?

A placebo is a dummy treatment that looks just like the real medicine but contains no active ingredients. It helps researchers compare how well the new medicine works.

Will I know if I'm getting the real medicine?

During the first part of the study, neither you nor your doctor will know if you're getting the active medicine or the placebo. This is called a 'double-blind' study.

How long will I be in the study?

The study could last anywhere from about 52 weeks (approx one year) to up to 160 weeks (over three years), depending on whether you join the optional longer treatment period.

What does 'severe hair loss' mean in this study?

For this study, severe hair loss means you've lost at least 50% of the hair on your scalp due to alopecia areata.