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

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

Official Title
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A Phase 3, Multicenter, Double-blind Maintenance Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND)

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Rocatinlimab
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARM A: Dose 1 to Dose 1<br>Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-Horizon, ROCKET-SHUTTLE, or ROCKET-ASTRO who received Dose 1 will be randomized or assigned to receive Dose 1 Every 4 Weeks (Q4W) or Every 8 Weeks (Q8W). Participants from parent Rocatinlimab study ROCKET-VOYAGER who received Dose 1 will be assigned to receive Dose 1 Q4W. | Drug: Rocatinlimab<br>* Subcutaneous (SC) injection<br>* Other names: KHK4083;|
| Experimental: ARM B: Dose 2 to Dose 2<br>Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-SHUTTLE, or ROCKET-ASTRO who received Dose 2 will be randomized or assigned to receive Dose 2 Q4W or Q8W. | Drug: Rocatinlimab<br>* Subcutaneous (SC) injection<br>* Other names: KHK4083;|
| Placebo Comparator: ARM C: Dose 1 or Dose 2 to Placebo<br>Participants from parent Rocatinlimab studies ROCKET-Ignite or ROCKET-Horizon who received Dose 1 will be randomized to receive placebo Q4W. Participants from parent Rocatinlimab study ROCKET-Ignite who received Dose 2 will be randomized to receive placebo Q4W. | Other: Placebo<br>* SC injection<br>|
| Placebo Comparator: ARM D: Placebo to Placebo<br>Participants from parent Rocatinlimab studies ROCKET- Ignite, ROCKET-Horizon, ROCKET-SHUTTLE, ROCKET-ASTRO, or ROCKET-VOYAGER who received placebo will be randomized or assigned to receive placebo Q4W. | Other: Placebo<br>* SC injection<br>|
| Experimental: ARM E: Dose 1, Dose 2, Placebo, or Open-label (OL) to OL Dose 1<br>Participants from parent Rocatinlimab studies ROCKET- Ignite, ROCKET-Horizon, ROCKET- SHUTTLE, ROCKET-ASTRO, or ROCKET-VOYAGER who received Dose 1, Dose 2, or placebo will be assigned to receive OL Rocatinlimab Dose 1 Q4W. Participants who received OL in parent Rocatinlimab study ROCKET- ASTRO will continue to receive OL Rocatinlimab Dose 1 Q4W. All participants from parent Rocatinlimab study ROCKET-Orbit will be assigned to receive OL Rocatinlimab Dose 1 Q4W. | Drug: Rocatinlimab<br>* Subcutaneous (SC) injection<br>* Other names: KHK4083;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-emergent Adverse Events |  | Up to 116 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintaining Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™) 0/1 Response Among Participants Achieving vIGA-AD™ 0/1 Response at Day 1 |  | Up to 104 weeks | 
| Maintaining vIGA-AD™ 1 Response with Presence of Only Barely Perceptible Erythema or vIGA-AD™ 0 Response Among Participants Achieving vIGA-AD™ 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD™ 0 Response at Day 1 |  | Up to 104 weeks | 
| Maintaining EASI 75 Response Among Participants Achieving EASI 75 Response at Day 1 |  | Up to 104 weeks | 
| Maintaining vIGA-AD™ 0/1 Response and EASI 75 Response Among Participants Achieving vIGA-AD™ 0/1 Response and EASI 75 Response at Day 1 |  | Up to 104 weeks | 
| Percent Change From Parent Study Baseline in EASI Score Among Participants Achieving EASI 75 Response at Day 1 |  | Up to 104 weeks | 
| Maintaining ≥ 4-point Reduction From Parent Study Baseline in Weekly Average of Daily Worst Pruritus Numerical Rating Scale (NRS) Score | Among Participants Achieving ≥ 4-point Reduction From Parent Study Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Day 1 | Up to 104 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis, Rocatinlimab, AMG 451, Eczema