Eczema (Atopic Dermatitis)
Eczema (Atopic Dermatitis)
20210142 Enrolling

Phase 3 Research Trial for Atopic Dermatitis – Eczema 1 (40 Weeks)

Treatment: Injection Age: 18 Years

Adults aged 18 and over with a diagnosis of atopic dermatitis (AD) for at least 6 months are needed for this research trial.  Eligible candidates must have a history of inadequate response to topical corticosteroids (TCS) of medium or high potency within 6 months, or for whom topical treatments are otherwise medically inadvisable.  In addition, there must be moderate to severe disease with an involvement of eczema on 10% or more of the body surface area (BSA).

Participants will receive an investigational medication (active study drug) or placebo via injection. Study medication and study-related assessments will be provided at no cost.  Reimbursement for study-related expenses may be provided.

Study participation will last about 40 weeks and involve about 11 visits to the study centre.

Participating Locations

Participating Experts

Dr. David N. Adam


Dr. Maryam Shayesteh Alam


Dr. Ake Baibergenova


Dr. Michael Corbo


Dr. Brandon Kirsch


Dr. Anil Kurian


Dr. Hermenio Lima


Dr. Mark Lomaga


Dr. Jaggi Rao


Dr. Kirsten Walker


Dr. Jensen Yeung


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The following information is from

Last Update Posted: September 24, 2023

Official Title

A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) ID




Study Description

  • Brief Summary:

    The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.

  • Condition or Disease:

    Atopic Dermatitis

  • Intervention/Treatment:

    Drug: Rocatinlimab
    Drug: Rocatinlimab
    Drug: Placebo
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    18 Years and 100 Years (Adult)

  • Sexes Eligible for Study:


Inclusion Criteria:

Age ≥ 18 years with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months
History of inadequate response to TCS (Topical Corticosteroid) of medium to higher potency within 6 months (with or without topical calcineurin inhibitors [TCI]).
EASI score ≥16
vIGA-AD score ≥3
≥10% body surface area (BSA) of AD involvement
Worst pruritus numerical rating scale ≥ 4

Exclusion Criteria:

Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1

Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:

Systemic corticosteroids
Systemic immunosuppressants
Janus kinase inhibitors

Treatment with any of the following medications or therapies within 1 week, prior to Day 1:

TCS of any potency
Topical phosphodiesterase type 4 inhibitors
Other topical immunosuppressive agents

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


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Eczema (Atopic Dermatitis)

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