Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

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 (SC)

Study Details

This is a single group, 1-arm, long-term safety study for treatment of participants with moderate to severe atopic dermatitis (AD). The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age ≥12 years old with moderate to severe AD. The study duration per participant will be up to 284 weeks, including: * A screening period of up to 2 to 4 weeks * An open label treatment period of up to 268 weeks (approximately 5 years) * A post-treatment safety follow-up period of at least 20 weeks after the last dose administration (last IMP administration at Week 264) The planned number of visits will be 35 visits.

Key Dates

Start date

Apr 3, 2023

Status verified

Apr 2026

Primary completion

Jun 11, 2031

Completion

Jun 11, 2031

Study Design

Enrollment

999 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Amlitelimab
  Subcutaneous injection as per protocol

Primary Outcome Measure

Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to end of study (EOS) (Week 284) ]

Locations (22)

Find similar trials in Birmingham, AL

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