Active not recruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

This study is for people aged 12 and older who have moderate-to-severe eczema (atopic dermatitis). Researchers are testing a new medicine called Amlitelimab. The main goal is to see if taking Amlitelimab regularly helps keep eczema under control compared to stopping the treatment. It also looks at whether different amounts of the medicine work well and if they are safe. The study involves participants who have already taken part in previous Amlitelimab studies. It's a 'Phase 3' study, meaning it's one of the final steps before a medicine might become widely available. Participants will be monitored for their eczema and any side effects over many months.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Sanofi

Enrolment target

1,541

Start

08 May 2024

Estimated completion

17 Mar 2027

Dermatitis Atopic

What is this study about?

This study is looking into a new medicine called Amlitelimab for people aged 12 and older who suffer from moderate-to-severe eczema. Eczema, also known as atopic dermatitis, can be very uncomfortable and affect daily life. The study aims to understand how well Amlitelimab works over time and if it's safe to use.

The main purpose of this particular study is to see if continuing to take Amlitelimab at certain doses helps keep eczema symptoms at bay, compared to stopping the treatment altogether. So, some people in the study will continue receiving the medicine, while others will stop. This helps doctors understand the long-term benefits of Amlitelimab. They also want to compare two different dosing schedules of the medicine to see which might be more effective or convenient. The study is 'double-blind,' which means neither you nor your study doctor will know whether you are receiving the active medicine or if your treatment has been stopped – this helps ensure the results are as fair and unbiased as possible.

This is a 'Phase 3' study, which means it's a large, important step in testing a new medicine. If the results are positive, it could mean that Amlitelimab might become an approved treatment for eczema in the future. The information gathered from this study will help healthcare professionals decide if this medicine is a good option for people with eczema.

Key takeaways

This study is for people aged 12+ with moderate-to-severe eczema who were in a previous Amlitelimab study.
It compares continuing Amlitelimab against stopping treatment.
It's a 'Phase 3' study, a key step for new medicines.
The study lasts up to 68 weeks, with regular health check-ups.
You won't know if you're getting the medicine or not (double-blind).
Participation is voluntary, and you can leave at any time.

Who may be eligible?

To join this study, you must be at least 12 years old. You also need to have already taken part in one of three previous Amlitelimab studies for moderate-to-severe eczema (COAST-1, COAST-2, or SHORE) and completed it properly, including receiving the study treatment without stopping early.

You should be able and willing to attend all study visits and follow the study instructions. Your body weight must be at least 25 kg (about 3 stone 13 pounds).

You cannot join if you developed any medical problems or severe side effects during the previous studies that would make continued treatment with Amlitelimab unsafe. You also can't join if your treatment was stopped early in the previous studies for reasons like not following instructions or if your doctor felt it wasn't safe for you to continue.

Quick self-check

Are you at least 12 years old?
Did you participate in and complete one of the previous Amlitelimab studies (COAST-1, COAST-2, or SHORE)?
Were you able to continue using the study medicine throughout that previous study?
Are you able and willing to attend all required study appointments?
Do you weigh at least 25 kg (55 lbs)?
Did you experience any medical issues in the previous study that your doctor felt made continued Amlitelimab treatment unsafe?

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

What does participation involve?

If you join this study, it will last for up to 68 weeks (about a year and three months). For the first 52 weeks (about a year), you will be randomly assigned to either continue receiving Amlitelimab or to stop treatment. Neither you nor your doctor will know which group you are in. Throughout this time, you will have regular study visits where doctors will check on your eczema and your general health through various assessments.

After these 52 weeks, if you don't go on to another long-term study, you will have a 16-week safety follow-up period. This means researchers will continue to check on your health and any side effects, even after the main treatment period has ended. If you do join another long-term study (called RIVER-AD) at week 52, your participation in this particular study will end at that point.

Potential risks and benefits

Taking part in this study may offer benefits, such as potentially continuing to receive a medicine that helped your eczema in a previous study. You'll also receive careful monitoring of your health and eczema by a medical team. However, there are potential risks, including side effects from the medication, which will be carefully monitored. Since some participants will stop treatment, their eczema symptoms might return or worsen. You can withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (326)

Cahaba Dermatology & Skin Health Center- Site Number : 8401066
Birmingham, United States
Center for Dermatology and Plastic Surgery- Site Number : 8401119
Scottsdale, United States
Scottsdale Clinical Trials- Site Number : 8401149
Scottsdale, United States
Eclipse Clinical Research- Site Number : 8401158
Tucson, United States
Johnson Dermatology- Site Number : 8401076
Fort Smith, United States
Encino Research Center- Site Number : 8401042
Encino, United States
First OC Dermatology- Site Number : 8401025
Fountain Valley, United States
Center for Dermatology Clinical Research- Site Number : 8401018
Fremont, United States
Marvel Clinical Research- Site Number : 8401102
Huntington Beach, United States
Sunwise Clinical Research- Site Number : 8401022
Lafayette, United States
Torrance Clinical Research - Narbonne Avenue- Site Number : 8401027
Lomita, United States
Dermatology Research Associates - Los Angeles- Site Number : 8401092
Los Angeles, United States

+314 more sites — see the official record for the full list.

Common questions

What is Amlitelimab?

Amlitelimab is a new medicine being tested for eczema (atopic dermatitis).

Who can join this study?

People aged 12 and over who have moderate-to-severe eczema and have already been part of a specific previous Amlitelimab study.

How long does the study last?

The study can last up to 68 weeks (about 1.5 years), including follow-up.

Will I definitely receive the medicine?

During the study, you will either continue with Amlitelimab or stop treatment, but neither you nor your doctor will know which group you are in.

What does 'moderate-to-severe eczema' mean?

This refers to eczema that significantly impacts your life and hasn't fully responded to milder treatments.