Rocatinlimab for Eczema
(ROCKET-Orbit Trial)

Recruiting in Palo Alto (17 mi)

+92 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Amgen

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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.

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

I am between 12 and 17 years old.

My skin condition didn't improve with strong creams in the last 6 months.

Topical treatments for my condition were either not effective or not suitable due to side effects.

+4 more

Exclusion Criteria

I haven't taken any biological medicines for the last 12 weeks or 5 half-lives, whichever is longer.

I haven't taken steroids, immunosuppressants, had phototherapy, or used JAK inhibitors recently.

I haven't used certain skin medications in the week before joining.

Participant Groups

The trial is testing the safety and effectiveness of Rocatinlimab in adolescents with AD. It aims to see how well participants tolerate this medication and if it improves their skin condition compared to previous treatments they've tried.

1Treatment groups

Experimental Treatment

Group I: RocatinlimabExperimental Treatment1 Intervention

Rocatinlimab will be administered subcutaneously every 4 weeks (Q4W) for 52 weeks with one additional dose at Week 2.