Eczema (Atopic Dermatitis)
Eczema (Atopic Dermatitis)
20210263 Enrolling

Phase 3 Research Trial for Atopic Dermatitis – Eczema 5 (68 Weeks)

Treatment: Injection Age: 12 Years

Recruiting adolescents from 12 to less than 18 years of age with a diagnosis of atopic dermatitis (AD) for at least 6 months for this research trial.  To qualify for the study, individuals must have moderate to severe disease with AD involvement of ≥10% of body surface area.  In addition, eligible participants must have a history of inadequate response to topical corticosteroids (TCS) of medium or higher potency within 6 months, or for whom topical treatments are otherwise medically inadvisable.

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

Study participation will last about 68 weeks and involve about 19 visits to the study centre.

Participating Locations


Participating Experts

Dr. Benjamin Barankin


Dr. Jennifer Beecker


Dr. Alim Devani


Dr. Michael Freeman


Dr. Anatoli Freiman


Dr. Mariam Hanna

Pediatric Allergist

Dr. Anil Kurian


Dr. Hermenio Lima


Dr. Douglas Mack

Pediatric Allergist

Dr. Vimal Prajapati


Dr. Maxwell Sauder


Dr. Geeta Yadav


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The following information is from

Last Update Posted: December 10, 2023

Official Title

A Phase 3, Open-label, 52-week Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab (AMG 451) in Adolescent Subjects Aged ≥ 12 to < 18 Years With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Orbit) ID




Study Description

  • Brief Summary:

    The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.

  • Condition or Disease:

    Atopic Dermatitis

  • Intervention/Treatment:

    Drug: Rocatinlimab
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    12 Years and 17 Years (Child)

  • Sexes Eligible for Study:


Inclusion Criteria:

Age ≥ 12 to < 18 years at day 1. Participant has a diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield, 2014]) that has been present for at least 12 months before signing of informed consent Prior to informed consent, history of inadequate response to topical corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors [TCI] as appropriate) or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks) Eczema Area and Severity Index (EASI) score ≥ 12 vIGA-AD score ≥ 3 ≥ 10% BSA of AD involvement at day 1 pre-enrollment 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 Phototherapy Oral or topical janus kinase inhibitors Treatment with any of the following agents within 1 week before day 1 pre-enrollment: Topical PDE4 inhibitors Other topical immunosuppressive agents (not including TCS/TCI) Combination topical agents containing a high- or super-high potency corticosteroid

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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