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Clinical Trials List

Protocol Number20210146
NCT Number(ClinicalTrials.gov Identfier)NCT05882877
Active

2023-05-31 - 2027-08-21

Phase III

Recruiting6

ICD-10L22

Diaper dermatitis

ICD-9691.0

Diaper or napkin rash

A Phase 3, Multicenter, Double-blind Maintenance Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND)

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chia-Yu Chu Division of Dermatology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Hung Lee 無
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yun-Ting Chang 無
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Hung Chung 無
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳南霖 無
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Chun Yang Division of Dermatology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Atopic Dermatitis

Objectives

This is a Phase 3, multicenter, double-blind maintenance trial evaluating the long-term safety, tolerability, and efficacy of rocatinlimab 300 mg and 150 mg in adult and adolescent subjects with moderate to severe AD. Trial populations will be included in the parent trial (e.g., 24-week adult parent trial 20210142, 20210143, 20210144, 20210158, or 52-week adolescent parent trial 20210145 or 20210263) Complete end-of-treatment visit (week 24 for adult and adolescent trials, respectively) and week 52) and meet the eligibility criteria. The total time of participation in the trial (including the parent trial and trial 20210146) is up to 2.5 years (subjects previously enrolled in the 52-week trial plan 20210142 will be treated in the adult open-label treatment group, and the total participation time of the parent trial and maintenance trial can be up to 3 years).

Test Drug

Rocatinlimab (AMG 451)

Active Ingredient

Rocatinlimab (AMG 451)

Dosage Form

Preservativefree solution for subcutaneous injection

Dosage

150 mg/mL

Endpoints

‧ Adverse events during treatment (including clinically significant laboratory test values ​​and changes in vital signs) and serious adverse events

Inclution Criteria

Inclusion Criteria:

Completion of an end of treatment duration visit (Week 24 or Week 52 visit for adult or adolescent studies, respectively) in a rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER) within the past 28 days.

Exclusion Criteria

Exclusion Criteria:

Permanent investigational product discontinuation due to safety-related reasons, protocol-defined stopping rules or conditions/reasons unrelated to efficacy during the rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER), or at the time of Screening or Day 1.

The Estimated Number of Participants

  • Taiwan

    53 participants

  • Global

    2200 participants

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