Atopic Dermatitis

A Phase 3, randomized, double-blind, placebo-controlled,
parallel-group, 3-arm, multinational, multicenter study to
evaluate the efficacy and safety of amlitelimab monotherapy
by subcutaneous injection in participants aged 12 years and
older with moderate-to-severe atopic dermatitis.

medical-cross
Atopic dermatitis
user
All genders
person-wave 12+
world
Recruiting now

Overview
Principal Investigator: Gabriela Cobos, MD

The total duration of this study for each participant is approximately 28 weeks, which includes a screening period of 4 weeks, followed by a 24-week double blind placebo-controlled treatment period. At the end of the treatment period, all participants will have the option to enter a separate study, the blinded extension study

Contact Us

user
Alysha Zipeto

Study details
Inclusion Criteria
  • Participants must have AD as defined by the American Academy of Dermatology
    Consensus Criteria for 1 year or longer at baseline
  • Participants must have documented history within 6 months prior to screening visit, of
    either inadequate response or inadvisability of topical treatments
  • EASI ≥16 at baseline visit, vIGA-AD of 3 or 4 at baseline visit, AD involvement of 10% or more of BSA at baseline visit
Exclusion Criteria
  • Prior use of any oral JAK inhibitor or topical ruxolitinib that exceeded 6 months



  • Skin co-morbidity that would adversely affect the ability to undertake AD assessments
    (eg, psoriasis, tinea corporis, lupus erythematosus) as per Investigator’s judgment
  • Prior use of any anti-OX40 or anti-OX40 ligand monoclonal antibody
Study Requirements

The study duration will be approximately 28 weeks with 9 study visits.