Rocatinlimab
Sponsors
Amgen Inc., Amgen
Conditions
AsthmaAtopic DermatitisModerate-to-severe AsthmaModerate-to-severe Atopic DermatitisPrurigo Nodularis
Early Phase 1
Phase 1
A Study to Evaluate Rocatinlimab (AMG 451) in Healthy Chinese Participants
CompletedNCT06214481
Start: 2024-01-23End: 2024-06-05Updated: 2026-01-07
A Study to Evaluate Bioavailability of Rocatinlimab Autoinjector and Vial in Healthy Participants
CompletedNCT06438263
Start: 2024-08-06End: 2025-07-02Updated: 2026-01-20
Phase 2
A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma
TerminatedNCT06376045
Start: 2024-05-24End: 2026-06-23Updated: 2026-08-11
A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Efficacy and Safety of Rocatinlimab in Adult Subjects With Moderate-to-severe Asthma
Active, not recruitingCTIS2023-508039-29-00
Start: 2024-09-16Target: 110Updated: 2025-09-01
Phase 3
A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)
CompletedNCT05398445
Start: 2022-05-31End: 2025-01-13Updated: 2026-07-23
A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
CompletedNCT05633355
Start: 2023-01-30End: 2025-07-31Updated: 2026-07-24
A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
CompletedNCT05651711
Start: 2022-12-14End: 2024-08-27Updated: 2026-06-26
A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
CompletedNCT05704738
Start: 2023-04-20End: 2025-11-25Updated: 2026-08-28
A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)
CompletedNCT05724199
Start: 2023-02-21End: 2024-12-04Updated: 2026-08-06
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) (ROCKET-Ignite)
CompletedCTIS2022-501540-15-00
Start: 2023-04-25End: 2024-09-03Target: 317Updated: 2024-12-04
A Phase 3, Randomized, 24-week,
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) (ROCKET-Horizon)
CompletedCTIS2022-501538-44-00
Start: 2023-04-25End: 2025-06-17Target: 234Updated: 2025-06-17
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)
CompletedCTIS2022-501585-22-00
Start: 2023-05-11End: 2025-06-16Target: 307Updated: 2025-06-16
A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
TerminatedNCT05882877
Start: 2023-05-31End: 2026-07-01Updated: 2026-07-16
A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)
CompletedNCT05899816
Start: 2023-06-07End: 2024-11-14Updated: 2026-07-23
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)
RecruitingCTIS2022-501587-17-00
Start: 2023-10-20Target: 615Updated: 2026-01-16
A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis
TerminatedNCT06527404
Start: 2024-07-18End: 2026-06-25Updated: 2026-07-27
A Phase 3, 52-Week, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab in Adult Subjects With Prurigo Nodularis Who are Inadequately Controlled on Topical Therapies or Not Eligible for Topical Therapies
Active, not recruitingCTIS2024-510753-10-00
Start: 2024-11-01Target: 183Updated: 2025-11-10