Atopic Dermatitis
Conditions
Keywords
Atopic Dermatitis, Rocatinlimab, AMG 451, Eczema
Brief summary
The primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD.
Interventions
DRUGRocatinlimab
Subcutaneous (SC) injection
OTHERPlacebo
SC injection
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment-emergent Adverse Events | Up to 116 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Week 32 | This outcome measure applies only to participants from parent rocatinlimab studies ROCKET-Ignite and ROCKET-Horizon who entered into the randomized treatment withdrawal cohort. |
| Maintaining a Revised IGA (rIGA™) 0/1 Response at Week 32 Among Participants Achieving rIGA™ 0/1 Response at Day 1 | Week 32 | This outcome measure applies only to participants from parent rocatinlimab studies ROCKET-Ignite and ROCKET-Horizon who entered into the randomized treatment withdrawal cohort. |
| Maintaining Eczema Area and Severity Index (EASI) 75 Response at Week 32 Among Participants Achieving EASI 75 Response at Day 1 | Week 32 | This outcome measure applies only to participants from parent rocatinlimab studies ROCKET-Ignite and ROCKET-Horizon who entered into the randomized treatment withdrawal cohort. |
| Maintaining EASI 90 Response at Week 32 Among Participants Achieving EASI 90 Response at Day 1 | Week 32 | This outcome measure applies only to participants from parent rocatinlimab studies ROCKET-Ignite and ROCKET-Horizon who entered into the randomized treatment withdrawal cohort. |
| 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 | Week 32 | This outcome measure applies only to participants from parent rocatinlimab studies ROCKET-Ignite and ROCKET-Horizon who entered into the randomized treatment withdrawal cohort. |
| 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 | Week 32 | This outcome measure applies only to participants from parent rocatinlimab studies ROCKET-Ignite and ROCKET-Horizon who entered into the randomized treatment withdrawal cohort. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORMD
Amgen
Outcome results
None listed