Eczema (Atopic Dermatitis)
main-banner
Eczema (Atopic Dermatitis)
EFC17599 Enrolling

Clinical Trial for Eczema (56 Weeks)


Treatment: Injection Age: 12 Years


Who Can Participate?

People aged 12 and above diagnosed with eczema (atopic dermatitis) may participate.

Inclusion Criteria

  • have a diagnosis of moderate to severe atopic dermatitis (AD)
  • have had inadequate response to biologic or oral treatments

What Are The Benefits?

  • No cost to participate or receive treatment
  • Regular visits with study doctors who specialize in treating AD (13 visits)
  • Will receive either an investigative injection treatment or a placebo

How Long Will The Study Last?

  • 56 weeks

Participating Locations

COUNTRY
country-icon
Canada

Participating Experts

Dr. Benjamin Barankin

Dermatologist

Dr. Anatoli Freiman

Dermatologist

Dr. Maxwell Sauder

Dermatologist

You May Also Be Interested In

Similar Trials

No Similar Trials Found

The following information is from ClinicalTrials.gov

Last Update Posted: July 02, 2024

Official Title

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (AD) Who Are on Background Topical Corticosteroids and Have Had an Inadequate Response to Prior Biologic Therapy or Oral Janus Kinase (JAK) Inhibitor Treatment

ClinicalTrials.gov ID

NCT06241118

Sponsor

Sanofi

Study Description

  • Brief Summary:

    This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate-to-severe AD aged 12 years and older on background TCS and have had an inadequate response to prior biologic or an oral JAKi therapy. Study details include: At the end of the treatment period, participants will have the option to enter the Long-Term Safety Study LTS17367 (RIVER-AD). The study duration will be up to 56 weeks for participants not entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up. The study duration will be up to 40 weeks for participants entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening and a 36-week randomized double-blind period. The total treatment duration will be up to 36 weeks. The total number of visits will be up to 13 visits (or 12 visits for those entering the long-term safety study LTS17367 \[RIVER-AD\] study).

  • Condition or Disease:

    Dermatitis Atopic

  • Intervention/Treatment:

    Drug: Amlitelimab,Drug: Topical corticosteroids,Drug: Topical tacrolimus or pimecrolimus Drug: Amlitelimab,Drug: Topical corticosteroids,Drug: Topical tacrolimus or pimecrolimus Drug: Placebo,Drug: Topical corticosteroids,Drug: Topical tacrolimus or pimecrolimus
  • Phase:

    PHASE3

  • Ages Eligible for Study:

    12 Years and older (CHILD,ADULT,OLDER_ADULT)

  • Sexes Eligible for Study:

    ALL

Inclusion Criteria

  • have a diagnosis of moderate to severe atopic dermatitis (AD)
  • have had inadequate response to biologic or oral treatments

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.



about-icon

Learn More About

Eczema (Atopic Dermatitis)

Learn More
2022 all rights reserved probity medical research inc
find a trial
filter trials
Skip to content