LTS17367

Moderate To Severe Atopic Dermatitis Research Trial – (332 Weeks)


Age: 18+



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The following information is from ClinicalTrials.gov

Last Update Posted: July 16, 2024

Official Title

A Long-term Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Subcutaneous Amlitelimab in Participants of Previous Amlitelimab Clinical Trials in Moderate to Severe Atopic Dermatitis.

ClinicalTrials.gov ID

NCT05492578

Sponsor

Sanofi

Study Description

  • Brief Summary:

    This is a single group, Phase 2, long-term extension study for treatment. The purpose of this study is to characterize the safety and efficacy of amlitelimab in treated adult participants with moderate to severe AD who have previously been enrolled in an amlitelimab clinical trial. Visits during the on-treatment period will be at Week 0, 1, 2, 4 and every 4 weeks (Q4W) thereafter. If remote visits are considered appropriate for participants instead of clinic visits at the timepoints indicated in the schedule of activities (SoA) participants/caregivers/legally authorized representatives (LAR) are allowed to perform participant-injections at home according to the schedule of dosing. This decision is at the discretion of the investigator.

  • Condition or Disease:

    Dermatitis Atopic

  • Intervention/Treatment:

    Drug: Amlitelimab,Other: Topical corticosteroids,Other: Topical calcineurin inhibitors,Other: Oral corticosteroids
  • Phase:

    PHASE2

  • Ages Eligible for Study:

    18 Years and older (ADULT,OLDER_ADULT)

  • Sexes Eligible for Study:

    ALL


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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