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Assessing the long-term effects of rocatinlimab for moderate-to-severe atopic dermatitis

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)

Phase 3 Interventional Amgen · NCT05882877

This study is testing if rocatinlimab is safe and effective for adults and teens with moderate-to-severe atopic dermatitis over a long period of time.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment2200 (estimated)
Ages12 Years to 100 Years
SexAll
SponsorAmgen Industry-sponsored
Drugs / interventionsrocatinlimab
Locations535 sites (Birmingham, Alabama and 534 other locations)
Trial IDNCT05882877 on ClinicalTrials.gov

What this trial studies

This study evaluates the long-term safety, tolerability, and efficacy of rocatinlimab in adults and adolescents suffering from moderate-to-severe atopic dermatitis. Participants who have completed a prior rocatinlimab study will be monitored for their response to the treatment over an extended period. The study includes both a treatment group receiving rocatinlimab and a placebo group for comparison. The primary goal is to ensure that the treatment is safe and effective for long-term use.

Who should consider this trial

Good fit: Ideal candidates are adults and adolescents who have previously participated in a rocatinlimab parent study and have shown significant improvement in their condition.

Not a fit: Patients who have previously discontinued rocatinlimab due to safety concerns or who did not meet the improvement criteria in the parent study may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new long-term treatment option for patients with moderate-to-severe atopic dermatitis.

How similar studies have performed: Other studies involving rocatinlimab have shown promising results, indicating a potential for success in this long-term assessment.

Eligibility criteria

Show full inclusion / exclusion 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.
* Participants from the parent study ROCKET-ORBIT must achieve an improvement in EASI score at week 52 of at least 60% compared to parent study baseline (EASI 60).

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.

Where this trial is running

Birmingham, Alabama and 534 other locations

+485 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atopic DermatitisRocatinlimabAMG 451Eczema
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.