Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials

Conditions

• Dermatitis Atopic

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Amlitelimab — DRUG
  Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
• Topical corticosteroids — DRUG
  Pharmaceutical form: Topical Route of administration: Topical
• Topical calcineurin inhibitors — DRUG
  Pharmaceutical form: Topical Route of administration: Topical
• Oral corticosteroids — DRUG
  Pharmaceutical form: Oral Route of administration: Oral

Study Details

This is an open-label, Phase 2/Phase 3, long-term extension study for treatment of participants of previous amlitelimab clinical trials in moderate to severe atopic dermatitis. The purpose of this study is to characterize the safety and efficacy of amlitelimab in treated participants with moderate to severe atopic dermatitis (AD) who have previously been enrolled in an amlitelimab clinical trial. All participants will have visits during the treatment period every 4 weeks. Responder participants rolling over from EFC17599 and EFC17600, and responder participants enrolling through screening from DRI17366 will be initiated into drug withdrawal (with no drug administration) at LTS17367 baseline visit to monitor durability of treatment response. If these responder participants relapse during LTS17367, they will have treatment restored. Non-responder participants rolling over from EFC17599 or EFC17600, and non-responder participants enrolling through screening from DRI17366 will have treatment administration from LTS17367 baseline. Participants rolling over from DRI17366, SFY17915 and INT18404 will also have treatment administration from LTS17367 baseline. Remote visits with home dosing are allowed for the purpose of study drug administration, when applicable. In the case of remote visit with home dosing, the participant or a caregiver may administer study drug after appropriate training. Alternatively, if needed, and based on the investigator's judgement, home visits with healthcare professional assistance or on-site study drug administration visits can be performed. Where participants discontinue amlitelimab permanently during LTS17367, safety follow up will be performed for a minimum of 140 days from the last amlitelimab administration.

Key Dates

Start date

Aug 22, 2022

Status verified

Jun 2026

Primary completion

Jan 22, 2029

Completion

Jan 22, 2029

Study Design

Enrollment

1,663 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Amlitelimab dose level 1
  Subcutaneous injection as per protocol
• Experimental: Amlitelimab dose level 2
  Subcutaneous injection as per protocol

Primary Outcome Measure

Percentage of participants who experienced treatment-emergent adverse event (TEAE) [ Time Frame: Baseline to Week 332 ]

Locations (96)

Find similar trials in Birmingham, AL

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• A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
  PHASE3 · Recruiting · Sanofi · Birmingham, Alabama