Study Description
Brief Summary
The coprimary objectives of the study are to:
- To evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD).
- To evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI at Week 24, assessed using Eczema Area and Severity Index (EASI).
Condition or Disease
Atopic Dermatitis
Study Design
| Study Type: | Interventional (Clinical Trial) |
| Estimated Enrollment: | 715 participants |
| Allocation: | Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Combination With Topical Corticosteroids and/or Topical Calcineurin Inhibitors in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE) |
| Actual Study Start Date: | February 21, 2023 |
| Estimated Primary Completion Date: | September 20, 2024 |
| Estimated Study Completion Date: | December 12, 2024 |
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 (American Academy of Dermatology) Consensus Criteria (2014) present for at least 6 months
- History of inadequate response to TCS of medium or higher potency within 6 months (with or without 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
- TCI
- Anti-pruritic agents
- Topical phosphodiesterase type 4 inhibitors
- Other topical immunosuppressive agents
- Combination topical agents including TCS of any potency or TCI, PDE4 inhibitors, or other topical immunosuppressive agents