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

NCT05882877

TerminatedPhase 3

Sponsor: Amgen

Conditions: Atopic Dermatitis

Interventions: Rocatinlimab, Placebo

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

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

Eligibility overview

Sex: ALL

Age: 12 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (547)
  • Birmingham, Alabama, United States
  • Phoenix, Arizona, United States
  • Phoenix, Arizona, United States
  • Scottsdale, Arizona, United States
  • Scottsdale, Arizona, United States
  • Bryant, Arkansas, United States
  • Hot Springs, Arkansas, United States
  • North Little Rock, Arkansas, United States
  • Bakersfield, California, United States
  • Canoga Park, California, United States
  • Dublin, California, United States
  • Encinitas, California, United States
  • Fountain Valley, California, United States
  • Lancaster, California, United States
  • Lancaster, California, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Northridge, California, United States
  • Orange, California, United States
  • Pasadena, California, United States
  • Sacramento, California, United States
  • Sacramento, California, United States
  • Sacramento, California, United States
  • San Diego, California, United States
  • San Francisco, California, United States
  • San Francisco, California, United States
  • Santa Ana, California, United States
  • Santa Monica, California, United States
  • + 517 more on CT.gov