Amlitelimab for Eczema
(ESTUARY Trial)

Recruiting in Palo Alto (17 mi)

+294 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Sanofi

Disqualifiers: Adverse events, Non-compliance, others

Pivotal Trial (Near Approval)

Prior Safety Data

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 64 weeks (for participants not entering the LTS17367 \[RIVER-AD\] study) including a 48-week randomized double-blind period, and a 16-week safety follow-up. The study duration will be up to 48 weeks for participants entering the LTS17367 \[RIVER-AD\] study at the Week 48 visit of EFC17600 (ESTUARY). The total treatment duration will be up to 48 weeks. The total number of visits will be up to 14 visits (or 13 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

+1 more

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.)

+3 more

Trial 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

Participant Groups

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.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Amlitelimab dose 2Experimental Treatment1 Intervention

Subcutaneous injection as per protocol

Group II: Amlitelimab dose 1Experimental Treatment1 Intervention

Subcutaneous injection as per protocol

Group III: PlaceboPlacebo Group1 Intervention

Subcutaneous injection as per protocol