A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe AD

Last updated: January 10, 2025
Sponsor: Amgen
Overall Status: Active - Not Recruiting

Phase

3

Condition

Eczema (Atopic Dermatitis)

Skin Infections/disorders

Hives (Urticaria)

Treatment

Rocatinlimab AI

Rocatinlimab Prefilled Syringe

Clinical Study ID

NCT06224192
20230180
  • Ages 12-100
  • All Genders

Study Summary

The primary objective of this study is to assess successful self-administration of rocatinlimab subcutaneous using devices for injection at home.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 12 at Day 1.

  • Diagnosis of AD according to American Academy of Dermatology (AAD) ConsensusCriteria (2014) that has been present for at least 12 months.

  • History of inadequate response to Topical Corticosteroids (TCS) of medium to higherpotency (with or without topical calcineurin inhibitors [TCI]).

  • Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) score ≥ 3at screening and pre-randomization.

  • Eczema Area and Severity Index (EASI) score ≥ 16 at initial at screening andpre-randomization.

  • ≥ 10% body surface area (BSA) of AD involvement at screening and pre-randomization.

Exclusion

Exclusion Criteria:

  • Treatment with a biological product within 12 weeks or 5 half-lives, whichever islonger, prior to day 1 pre-randomization.

  • Treatment with any of the following medications or therapies within 5 half-livesprior to day 1 pre-randomization:

  1. Systemic corticosteroids

  2. Non-biologic, non-targeted systemic immunosuppressants

  3. Oral or Topical Janus kinase inhibitors

  • Treatment with any of the following medications or therapies within 1 week beforeday 1 pre-randomization:
  1. Topical phosphodiesterase 4 (PDE4) inhibitors

  2. Other topical immunosuppressive agents (not including TCS/TCI)

  3. Combination topical agents containing any of the above components

Study Design

Total Participants: 151
Treatment Group(s): 2
Primary Treatment: Rocatinlimab AI
Phase: 3
Study Start date:
April 02, 2024
Estimated Completion Date:
March 11, 2026

Connect with a study center

  • Interior Dermatology Centre

    Kelowna, British Columbia V1W 4V5
    Canada

    Site Not Available

  • LEADER Research

    Hamilton, Ontario L8L 3C3
    Canada

    Site Not Available

  • Lynderm Research Inc

    Markham, Ontario L3P 1X3
    Canada

    Site Not Available

  • DermEdge Research Incorporated

    Mississauga, Ontario L4Y 4C5
    Canada

    Site Not Available

  • Allergy Research Canada Incorporated

    Niagara Falls, Ontario L2H 1H5
    Canada

    Site Not Available

  • North Bay Dermatology Centre

    North Bay, Ontario P1B 3Z7
    Canada

    Site Not Available

  • Dermatology Ottawa Research Centre

    Ottawa, Ontario K2C 3N2
    Canada

    Site Not Available

  • FACET Dermatology

    Toronto, Ontario M4E 1R7
    Canada

    Site Not Available

  • Alliance Clinical Trials

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • XLR8 Medical Research, Incorporated

    Windsor, Ontario N8T 1E6
    Canada

    Site Not Available

  • Skinsense Medical Research

    Saskatoon, Saskatchewan S7K 2C1
    Canada

    Site Not Available

  • Ekihigashi Dermatology Allergy Clinic

    Fukuoka-shi, Fukuoka 812-0013
    Japan

    Site Not Available

  • Fukuoka University Hospital

    Fukuoka-shi, Fukuoka 814-0180
    Japan

    Site Not Available

  • Matsuo Clinic

    Fukuoka-shi, Fukuoka 819-0373
    Japan

    Site Not Available

  • Suizenji Dermatology Clinic

    Kumamoto-shi, Kumamoto 862-0950
    Japan

    Site Not Available

  • Dermatology and Ophthalmology Kume Clinic

    Sakai-shi, Osaka 593-8324
    Japan

    Site Not Available

  • Mita Dermatology Clinic

    Minato-ku, Tokyo 108-0014
    Japan

    Site Not Available

  • Keio University Hospital

    Shinjuku-ku, Tokyo 160-8582
    Japan

    Site Not Available

  • Korea University Ansan Hospital

    Ansan-si, Gyeonggi-do, 15355
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, 07441
    Korea, Republic of

    Site Not Available

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278
    Korea, Republic of

    Site Not Available

  • Severance Hospital Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon-si, Gyeonggi-do, 16499
    Korea, Republic of

    Site Not Available

  • Kern Research Inc

    Bakersfield, California 93301
    United States

    Site Not Available

  • Long Beach Research Institute

    Long Beach, California 90805
    United States

    Site Not Available

  • Dermatology Research Associates

    Los Angeles, California 90045
    United States

    Site Not Available

  • Havana Research Institute Inc

    Pasadena, California 91105
    United States

    Site Not Available

  • Integrative Skin Science and Research

    Sacramento, California 95815
    United States

    Site Not Available

  • Direct Helpers Research Center

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Anchor Medical Research

    Miami, Florida 33176
    United States

    Site Not Available

  • Hamilton Research, LLC

    Alpharetta, Georgia 30022
    United States

    Site Not Available

  • Treasure Valley Medical Research

    Boise, Idaho 83706
    United States

    Site Not Available

  • Dermatology and Skin Cancer Center Leawood

    Leawood, Kansas 66211
    United States

    Site Not Available

  • Excel Clinical Research

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Las Vegas Clinical Trials

    North Las Vegas, Nevada 89030
    United States

    Site Not Available

  • Skin Cancer and Dermatology Institute

    Reno, Nevada 89509
    United States

    Site Not Available

  • The Skin Surgery Center for Clinical Research

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Bexley Dermatology Research

    Bexley, Ohio 43209
    United States

    Site Not Available

  • Apex Clinical Research Center LLC

    Mayfield Heights, Ohio 44124
    United States

    Site Not Available

  • Essential Medical Research LLC

    Tulsa, Oklahoma 74137
    United States

    Site Not Available

  • Health Concepts

    Rapid City, South Dakota 57702
    United States

    Site Not Available

  • Cumberland Skin Center

    Hermitage, Tennessee 37076
    United States

    Site Not Available

  • Sms Clinical Research Limited Liability Company

    Mesquite, Texas 75149
    United States

    Site Not Available

  • Texas Dermatology Research Center

    Plano, Texas 75025
    United States

    Site Not Available

  • Virginia Dermatology and Skin Cancer Center

    Norfolk, Virginia 23502
    United States

    Site Not Available

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