Rocatinlimab for Eczema
(ROCKET-Orbit Trial)
Trial Summary
What is the purpose of this trial?
This trial tests the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe atopic dermatitis. Rocatinlimab works by reducing inflammation and calming the immune system.
Will I have to stop taking my current medications?
The trial requires you to stop certain medications before starting. You must stop biological products 12 weeks before, systemic corticosteroids, immunosuppressants, phototherapy, and janus kinase inhibitors 4 weeks before, and certain topical treatments 1 week before joining the trial.
What data supports the effectiveness of the drug Rocatinlimab for eczema?
Is rocatinlimab safe for humans?
Research Team
MD
Principal Investigator
Amgen
Eligibility Criteria
Adolescents aged 12 to under 18 with moderate-to-severe atopic dermatitis (AD) who haven't responded well to strong topical corticosteroids or when such treatments are not advised. Participants should have had AD for at least a year, an EASI score of ≥12, and more than 10% body surface area affected.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Rocatinlimab is administered subcutaneously every 4 weeks for 52 weeks with one additional dose at Week 2
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Rocatinlimab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London