Rocatinlimab for Atopic Dermatitis
(ROCKET-ASTRO Trial)

Recruiting in Palo Alto (17 mi)

+270 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 is testing a medication called rocatinlimab to see if it works and is safe for teenagers. The medication can be used by itself or with other treatments. It aims to help by interacting with the immune system.

Research Team

Principal Investigator

Amgen

Eligibility Criteria

Adolescents aged 12-17 with moderate-to-severe atopic dermatitis (eczema) who haven't responded well to certain creams and ointments can join. They must weigh at least 40 kg, have a significant area of their body affected, and experience notable itchiness. Those who've used strong medications or therapies for eczema in the month before the trial starts cannot participate.

Inclusion Criteria

Your vIGA-AD score is 3 or higher.

Over 10% of my skin is affected by atopic dermatitis.

I have severe itching rated 4 or higher on a scale.

See 5 more

Exclusion Criteria

I haven't used any strong skin medications or therapies in the last week.

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

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

Treatment Details

Interventions

Placebo (Other)
Rocatinlimab (Monoclonal Antibodies)

Trial OverviewThe study is testing Rocatinlimab's effectiveness and safety as a solo treatment or combined with other treatments for adolescents with severe skin inflammation due to eczema. Some participants will receive Rocatinlimab while others will get a placebo (a substance with no active drug).

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Arm D: Open-Label Dose 1Experimental Treatment1 Intervention

Part 2; Week 24 to Week 52: Part 1 Non-Responders will be reassigned at Week 24 with Rocatinlimab Open-label Dose 1 Q4W for 28 weeks (with TCS/TCI if within combination therapy cohort). Participants in Arms A, B or C Maintenance Period will be reassigned with Rocatinlimab Open-label Dose 1 Q4W (with TCS/TCI if within combination therapy cohort) upon relapse after Week 24.

Group II: Arm C: PlaceboExperimental Treatment2 Interventions

Part 1 (Initial Period); Week 0 to Week 24: Placebo Q4W for 24 weeks with loading dose at Week 2 (+TCS/TCI if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be reassigned at Week 24 with Placebo Q4W for 28 weeks (with TCS/TCI if within combination therapy cohort).

Group III: Arm B: Dose 2Experimental Treatment1 Intervention

Part 1 (Initial Period); Week 0 to Week 24: Rocatinlimab Dose 2 Q4W for 24 weeks with loading dose at Week 2 (+TCS/TCI if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be rerandomised at Week 24 to Rocatinlimab Dose 2 Q4W or Q8W for 28 weeks (with TCS/TCI if within combination therapy cohort).

Group IV: Arm A: Dose 1Experimental Treatment1 Intervention

Part 1 (Initial Period); Week 0 to Week 24: Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with loading dose at Week 2 (+ topical corticosteroids (TCS)/ topical calcineurin inhibitor (TCI) if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be rerandomised at Week 24 to Rocatinlimab Dose 1 Q4W or every 8 weeks (Q8W) for 28 weeks (+ TCS/TCI if within combination therapy cohort).