Amlitelimab for Eczema

(ESTUARY Trial)

Recruiting at 579 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi

Disqualifiers: Adverse events, Non-compliance, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 14

Duration: 48 weeks

1500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called amlitelimab for individuals with moderate-to-severe eczema, also known as atopic dermatitis. The main goal is to determine if those who responded well to amlitelimab in earlier studies can maintain clear skin when continuing the treatment or switching doses. Participants will receive one of two doses of amlitelimab or a placebo (a non-active treatment) to compare results. Those who have participated in a related study and have moderate-to-severe eczema affecting daily life might find this trial suitable. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to contribute to the validation of a potentially effective treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that amlitelimab is likely to be safe for humans?

Research has shown that amlitelimab is generally well-tolerated by people with atopic dermatitis (AD). In earlier studies, adults who used amlitelimab reported few serious side effects over a year of treatment. These studies found that the drug not only reduced symptoms but did so safely. Another study confirmed that amlitelimab significantly improved AD symptoms without major safety issues.

Amlitelimab has been tested in both adults and teenagers with AD, achieving its main goals for effectiveness and safety. So far, the safety results appear promising. However, as research continues, more information will help confirm these findings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for eczema?

Unlike the standard eczema treatments, which often involve topical steroids or immunosuppressants like cyclosporine, Amlitelimab offers a fresh approach by targeting the OX40L pathway, a key player in the immune response. This new mechanism of action aims to modulate the immune system more precisely, potentially reducing inflammation with fewer side effects. Researchers are excited because Amlitelimab is administered as a subcutaneous injection, possibly allowing for longer intervals between doses and improving patient convenience. Moreover, its targeted action could mean a more effective treatment for those who don't respond well to existing therapies.

What evidence suggests that amlitelimab could be an effective treatment for eczema?

Research shows that amlitelimab may help treat moderate-to-severe atopic dermatitis, a type of eczema. In earlier studies, this treatment greatly reduced skin symptoms and related signs in patients. Many participants saw noticeable improvements, with some experiencing a 50% or even 90% reduction in their eczema severity. In this trial, participants will receive either one of two doses of amlitelimab or a placebo. These findings suggest amlitelimab could provide significant relief for people with eczema. Overall, participants have tolerated it well, making it a promising option for future treatments. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for people aged 12 and older with moderate-to-severe atopic dermatitis, who responded well to a previous amlitelimab study. Participants must have been part of earlier COAST or SHORE studies and shown improvement.

Inclusion Criteria

My body weight is at least 25 kg.

I am 12 years old or older.

Able and willing to comply with requested study visit and procedures

Exclusion Criteria

Developed a medical condition that would preclude participation as described in Permanent Discontinuation of EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) clinical trial protocols

Having received any prohibited medication or procedure for AD that resulted in IMP discontinuation in the parent study EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE)

Conditions in the parent study EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) that led to Investigator- or Sponsor-initiated withdrawal of participant from the study (eg, non-compliance, inability to complete study assessments, etc.)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive amlitelimab or placebo via subcutaneous injection for up to 48 weeks

48 weeks

Up to 14 visits (or 13 visits for those entering LTS17367 [RIVER-AD] study)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term in the LTS17367 [RIVER-AD] study

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Amlitelimab

Trial Overview The trial tests two different doses of the drug amlitelimab against no treatment (placebo) to see if it helps maintain skin condition improvements in participants. It's randomized, double-blind, and lasts up to 64 weeks with around 14 visits.

How Is the Trial Designed?

Group I: Amlitelimab dose 2 Experimental Treatment 1 Intervention

Subcutaneous injection as per protocol

Group II: Amlitelimab dose 1 Experimental Treatment 1 Intervention

Subcutaneous injection as per protocol

Group III: Placebo Placebo Group 1 Intervention

Subcutaneous injection as per protocol

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Citations

1. sanofi.com sanofi.com/en/media-room/press-releases/2025/2025-09-04-05-00-00-3144170

Press Release: Sanofi's amlitelimab met all primary and ... “Amlitelimab may represent a significant advance in the treatment of atopic dermatitis with clinically meaningful and progressively increasing ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39522654/

Phase 2b randomized clinical trial of amlitelimab, an anti- ... Amlitelimab treatment significantly reduced clinical and biomarker responses, and was well tolerated in adults with AD through week 52.

3. jacionline.org jacionline.org/article/S0091-6749(24)01175-8/fulltext

Phase 2b randomized clinical trial of amlitelimab, an anti ... For other secondary efficacy outcomes, greater proportions of patients achieved a 50% reduction in EASI and 90% reduction in EASI and greater ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41035282/

Population Pharmacokinetic and Pharmacodynamic ... Simulations identified that a twofold dose reduction would allow participants < 40 kg to achieve amlitelimab exposures within the range observed ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03754309

NCT03754309 | A Study of KY1005 in Patients With ... The purpose of this research study is to investigate if KY1005 results in improvement of eczema when given to participants with moderate to severe disease. Side ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05131477

NCT05131477 | Study Testing Response Effect of KY1005 ... Also called a data safety and monitoring board, or DSMB. ... Improvement and maintenance of clinical outcome assessments in atopic dermatitis with amlitelimab.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37463508/

Safety and efficacy of amlitelimab, a fully human ... Novel targeting of OX40L-expressing APCs with amlitelimab was well tolerated and resulted in clinically meaningful improvements in AD.