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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cahaba Dermatology and Skin Health Center
  Birmingham, Alabama, United States Recruiting
• Medical Dermatology Specialists
  Phoenix, Arizona, United States Recruiting
• Alliance Dermatology and Mohs Center
  Phoenix, Arizona, United States Recruiting
• Affiliated Dermatology
  Scottsdale, Arizona, United States Recruiting
• Scottsdale Clinical Trials
  Scottsdale, Arizona, United States Recruiting
• Dermatology Trial Associates
  Bryant, Arkansas, United States Recruiting

+485 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Amgen Call Center
• Email: medinfo@amgen.com
• Phone: 866-572-6436

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.