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Study Complete
Sponsor ID
20230180

A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe Atopic DermatitisROCKET-Outpost

Sponsor ID
20230180
Clinicaltrials.gov ID
NCT06224192
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The primary objective of this study is to assess successful self-administration of rocatinlimab subcutaneously using devices for injection.

Additional Study Details

Phase
Phase 3
Product
Rocatinlimab
Type
Interventional
Masking
None (Open Label)
Enrollment
151
Additional Study Details

Protocol Summary

Primary Outcome Measures

Proportion of Full-dose Self-administered Rocatinlimab Injections Among Total Attempted Injections up to Week 16

Timeframe: Up to Week 16

Secondary Outcome Measures

Proportion of Devices that Have Been Reported with Product Complaints Related to Function by Participants, Caregivers, or Investigators Among Total Dispensed Devices up to Week 16

Timeframe: Up to Week 16

Locations

Location
Status
Contact Us
Location
Anchor Medical Research
Miami, FL, United States, 33176
Status
Recruiting
Location
Apex Clinical Research Center LLC
Mayfield Heights, OH, United States, 44124
Status
Recruiting
Location
Hamilton Research, LLC
Alpharetta, GA, United States, 30022
Status
Recruiting
Location
Dermatology Research Associates
Los Angeles, CA, United States, 90045
Status
Recruiting
Location
Essential Medical Research LLC
Tulsa, OK, United States, 74137
Status
Recruiting
Location
Excel Clinical Research
Las Vegas, NV, United States, 89109
Status
Recruiting
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Study Info
Age
12 - 100 Years
Condition
  • Atopic Dermatitis
    • Sex
    All
    Trial Dates
    Apr 2024 - Apr 2025
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Age ≥ 12 at Day 1. • Diagnosis of AD according to American Academy of Dermatology (AAD) Consensus Criteria (2014) that has been present for at least 12 months. • History of inadequate response to Topical Corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors [TCI]). • Validated Investigator Global Assessment for Atopic Dermatitis (vIGA‐AD™) score ≥ 3 at screening and pre-randomization. • Eczema Area and Severity Index (EASI) score ≥ 16 at initial at screening and pre-randomization. • ≥ 10% body surface area (BSA) of AD involvement at screening and pre-randomization.
    Exclusion Criteria:
    • Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 pre-randomization. • Treatment with any of the following medications or therapies within 5 half-lives prior to day 1 pre-randomization: 1. Systemic corticosteroids 2. Non-biologic, non-targeted systemic immunosuppressants 3. Oral or Topical Janus kinase inhibitors • Treatment with any of the following medications or therapies within 1 week before day 1 pre-randomization: 1. Topical phosphodiesterase 4 (PDE4) inhibitors 2. Other topical immunosuppressive agents (not including TCS/TCI) 3. Combination topical agents containing any of the above components