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Terminated/Withdrawn
Sponsor ID
20210146

A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)ROCKET-ASCEND

Sponsor ID
20210146
Clinicaltrials.gov ID
NCT05882877
EUCTIS ID
N/A
EudraCT ID
2022-501587-17
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Study Details

The primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD.

Additional Study Details

Phase
Phase 3
Product
Rocatinlimab
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
2621
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants With Treatment-emergent Adverse Events

Timeframe: Up to 116 weeks

Secondary Outcome Measures

Maintaining Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™) 0/1 Response at Week 32 Among Participants Achieving vIGA-AD™ 0/1 Response at Day 1

Timeframe: Week 32

Maintaining a Revised IGA (rIGA™) 0/1 Response at Week 32 Among Participants Achieving rIGA™ 0/1 Response at Day 1

Timeframe: Week 32

Maintaining Eczema Area and Severity Index (EASI) 75 Response at Week 32 Among Participants Achieving EASI 75 Response at Day 1

Timeframe: Week 32

Maintaining EASI 90 Response at Week 32 Among Participants Achieving EASI 90 Response at Day 1

Timeframe: Week 32

Maintaining vIGA-AD™ 0/1 Response and EASI 75 Response at Week 32 Among Participants Achieving vIGA-AD™ 0/1 Response and EASI 75 Response at Day 1

Timeframe: Week 32

Maintaining ≥ 4-point Reduction from Parent Study Baseline in Worst Pruritus NRS Score at Week 32 Among Participants Achieving ≥ 4 Point Reduction from Parent Study Baseline in Worst Pruritus NRS Score at Day 1

Timeframe: Week 32

Locations

Location
Status
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Location
Saint Jude Clinical Research
Doral, FL, United States, 33172
Status
Recruiting
Location
Dermatology Research Associates
Los Angeles, CA, United States, 90045
Status
Recruiting
Location
Revival Research Institute LLC
Troy, MI, United States, 48084
Status
Recruiting
Location
California Dermatology and Clinical Research Institute
Encinitas, CA, United States, 92024
Status
Recruiting
Location
CCA Medical Research Corp
Ajax, ON, Canada, L1S 7K8
Status
Recruiting
Location
Doctor Chih-Ho Hong Medical Incorporated
Surrey, BC, Canada, V3R 6A7
Status
Recruiting
Showing {first} - {last} of {total} Results
Study Info
Age
12 - 100 Years
Condition
  • Atopic Dermatitis
    • Sex
    All
    Trial Dates
    May 2023 - Jul 2026
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Completion of an end of treatment duration visit (Week 24 or Week 52 visit for adult or adolescent studies, respectively) in a rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER) within the past 28 days. - Participants from the parent study ROCKET-ORBIT must achieve an improvement in EASI score at week 52 of at least 60% compared to parent study baseline (EASI 60).
    Exclusion Criteria:
    - Permanent investigational product discontinuation due to safety-related reasons, protocol-defined stopping rules or conditions/reasons unrelated to efficacy during the rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER), or at the time of Screening or Day 1.