Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.
Condition or Disease
Moderate-to-Severe Atopic Dermatitis
Study Design
| Study Type: | Interventional (Clinical Trial) |
| Actual Enrollment: | 700 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) |
| Actual Study Start Date: | May 31, 2022 |
| Actual Primary Completion Date: | January 6, 2025 |
| Actual Study Completion Date: | March 30, 2025 |
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
- Age ≥ 18 years with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 6 months
- History of inadequate response to TCS (Topical Corticosteroid) of medium or higher potency within 6 months (with or without topical calcineurin inhibitors [TCI])
- EASI score ≥16
- vIGA-AD score ≥3
- ≥10% body surface area (BSA) of AD involvement
- Worst pruritus numerical rating scale ≥ 4
Exclusion Criteria
- Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1
- Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:
- Systemic corticosteroids
- Systemic immunosuppressants
- Phototherapy
- Janus kinase inhibitors
- Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
- TCS of any potency
- TCI
- Anti-pruritic drug
- Topical phosphodiesterase type 4 inhibitors
- Other topical immunosuppressive agents