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Rocatinlimab Dose 1 for Atopic Dermatitis (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 week 12
Awards & highlights
ROCKET-Outpost Trial Summary
The primary objective of this study is to assess successful self-administration of rocatinlimab subcutaneous using devices for injection at home.
Eligible Conditions
- Atopic Dermatitis
ROCKET-Outpost Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of full-dose self-administered rocatinlimab injections as reported by participants or caregivers among attempted home-use injections at weeks 4 and 12 combined
Secondary outcome measures
Proportion of devices that have been reported with Product Complaints by participants, caregivers, or investigators among dispensed home-use devices at weeks 4 and 12 combined
ROCKET-Outpost Trial Design
2Treatment groups
Experimental Treatment
Group I: Rocatinlimab Dose 2Experimental Treatment1 Intervention
Rocatinlimab will be self-administered subcutaneously using a PFS. Participants will receive rocatinlimab Q4W for 52 weeks with a loading dose at week 2.
Group II: Rocatinlimab Dose 1Experimental Treatment1 Intervention
Rocatinlimab will be self-administered subcutaneously using a prefilled syringe (PFS). Participants will receive rocatinlimab every 4 weeks (Q4W) for 52 weeks with a loading dose at week 2.
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Who is running the clinical trial?
AmgenLead Sponsor
1,371 Previous Clinical Trials
1,378,118 Total Patients Enrolled
MDStudy DirectorAmgen
915 Previous Clinical Trials
924,630 Total Patients Enrolled
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