Amlitelimab for Eczema

(ESTUARY Trial)

Recruiting at 355 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

961 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 3 study for treatment of participants aged 12 years and older diagnosed with moderate-to-severe atopic dermatitis (AD). The main objective of this study is to evaluate if those participants who received amlitelimab dose 1 in the parent studies (EFC17559 \[COAST-1\], EFC17560 \[COAST 2\], EFC17561 \[SHORE\]) and were responders can maintain their response either remaining at dose 1 or switching to dose 2 of amlitelimab compared to treatment withdrawal. Study details include: The study duration will be up to 68 weeks including a 52-week randomized double-blind period, and a 16-week safety follow-up for participants not entering the LTS17367 (RIVER-AD). The study duration will be up to 52 weeks for participants entering the LTS17367 \[RIVER-AD\] study at the Week 52 visit of EFC17600 (ESTUARY). The total treatment duration will be up to 52 weeks. The total number of visits will be up to 15 visits (or 14 visits for those entering LTS17367 \[RIVER-AD\] study).

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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