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

Phase 3Active Not RecruitingNCT05882877

Amgen2,621 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

2,621

Conditions

Atopic Dermatitis

Interventions

RocatinlimabDRUG

Subcutaneous (SC) injection

SC injection

Eligibility

Sex: ALLMin age: 12 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (547)

Outcomes

Primary Outcomes

Number of Participants With Treatment-emergent Adverse Events

Time frame: Up to 116 weeks

Secondary Outcomes

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

This outcome measure applies only to participants from parent rocatinlimab studies ROCKET-Ignite and ROCKET-Horizon who entered into the randomized treatment withdrawal cohort.

Time frame: Week 32

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

This outcome measure applies only to participants from parent rocatinlimab studies ROCKET-Ignite and ROCKET-Horizon who entered into the randomized treatment withdrawal cohort.

Time frame: Week 32

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

This outcome measure applies only to participants from parent rocatinlimab studies ROCKET-Ignite and ROCKET-Horizon who entered into the randomized treatment withdrawal cohort.

Time frame: Week 32

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

This outcome measure applies only to participants from parent rocatinlimab studies ROCKET-Ignite and ROCKET-Horizon who entered into the randomized treatment withdrawal cohort.

Time frame: 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

This outcome measure applies only to participants from parent rocatinlimab studies ROCKET-Ignite and ROCKET-Horizon who entered into the randomized treatment withdrawal cohort.

Data from ClinicalTrials.gov

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NCT05882877 - A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD) | Crick | Crick