A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

Phase 3

Active, not recruiting

• Conditions: Atopic Dermatitis
• Interventions: Drug: Rocatinlimab

• Registration Number: NCT05633355
• Lead Sponsor: Amgen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-22
• Study First Submitted QC: 2022-11-22
• Study First Posted: 2022-12-01
• Study Start: 2023-01-30
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-03
• Primary Completion: 2025-07-28
• Study Completion: 2025-07-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 187

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rocatinlimab	Rocatinlimab	Rocatinlimab will be administered subcutaneously every 4 weeks (Q4W) for 52 weeks with one additional dose at Week 2.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-emergent Serious Adverse Events	Up to 52 Weeks

Trial Locations

Locations (77)

Phoenix Childrens Hosptial; 🇺🇸 Phoenix, Arizona, United States

Medical Advancement Centers of Arizona; 🇺🇸 Tempe, Arizona, United States

Dermatology Trial Associates; 🇺🇸 Bryant, Arkansas, United States

Little Rock Allergy and Asthma Clinical Research Center; 🇺🇸 Little Rock, Arkansas, United States

University of California Irvine; 🇺🇸 Irvine, California, United States

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

Dermatology Research Associates; 🇺🇸 Los Angeles, California, United States

Manlio Dermatology; 🇺🇸 Kissimmee, Florida, United States

Deluxe Health Care LLC; 🇺🇸 Miami Lakes, Florida, United States

Palm Springs Community Health Center; 🇺🇸 Miami, Florida, United States

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