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A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe AD (ROCKET-Outpost Trial)

Phase 3
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing whether people can successfully give themselves rocatinlimab injections at home. Rocatinlimab is a medication that is injected under the skin. The study aims to make it easier for patients to manage their treatment without needing to visit the hospital regularly.

Eligible Conditions
  • Atopic Dermatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Rocatinlimab Dose 2 PFSExperimental Treatment1 Intervention
Rocatinlimab will be self-administered subcutaneously using a PFS. Participants will receive rocatinlimab for 52 weeks.
Group II: Rocatinlimab Dose 2 Autoinjector (AI)Experimental Treatment1 Intervention
Rocatinlimab will be self-administered subcutaneously using an AI. Participants will received rocatinlimab for 52 weeks.
Group III: Rocatinlimab Dose 1 Prefilled Syringe (PFS)Experimental Treatment1 Intervention
Rocatinlimab will be self-administered subcutaneously using a PFS. Participants will receive rocatinlimab for 52 weeks.

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Who is running the clinical trial?

AmgenLead Sponsor
1,442 Previous Clinical Trials
1,397,594 Total Patients Enrolled
MDStudy DirectorAmgen
980 Previous Clinical Trials
941,350 Total Patients Enrolled
~58 spots leftby Jun 2025
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