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rocatinlimab

rocatinlimab: 9 clinical trials tracked.

rocatinlimab evidence translation

What we can confirm

9 tracked trials

No verified listed company relationship

What it means

AI will separate confirmed drug evidence from unknown company context.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

What is verified about rocatinlimab, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence2 indications · 1 study sponsors
Clinical Trial Registry Records (9)

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

NCT06527404Registry updated 2026-07-27·Phase 3·AMGN
Terminated

Primary endpoint: Global: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24

InterventionalRandomizeddouble469 enrolledStarted 2024-07Completion 2026-0650 sites · Argentina, Australia, Austria, Belgium…Amgen

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

NCT06376045Registry updated 2026-08-11·Phase 2·AMGN
Terminated

Primary endpoint: Annualized Rate of Composite Endpoint for Exacerbations (CompEx) Events During the Blinded Treatment Period

InterventionalRandomizeddouble317 enrolledStarted 2024-05Completion 2026-0650 sites · Argentina, United StatesAmgen

A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Effect of Rocatinlimab on Vaccine Antibody Response in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)

NCT05899816Registry updated 2026-07-23·Phase 3·AMGN
Completed

Primary endpoint: Percentage of Participants With a Positive Anti-tetanus Response at Week 24

InterventionalRandomizeddouble221 enrolledStarted 2023-06Completion 2024-1150 sites · United StatesAmgen

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)

NCT05882877Registry updated 2026-07-16·Phase 3·AMGN
Terminated

Primary endpoint: Number of Participants With Treatment-emergent Adverse Events

InterventionalRandomizeddouble2,621 enrolledStarted 2023-05Completion 2026-0750 sites · United StatesAmgen

A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Re-randomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)

NCT05704738Registry updated 2026-08-28·Phase 3·AMGN
Completed

Primary endpoint: Number of Participants Who Achieved vIGA-AD 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24

InterventionalRandomizeddouble532 enrolledStarted 2023-04Completion 2025-1150 sites · United StatesAmgen

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)

NCT05724199Registry updated 2026-08-06·Phase 3·AMGN
Completed

Primary endpoint: Number of Participants Who Achieved Validated Investigator's Global Assessment for AD (vIGA-AD) 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24

InterventionalRandomizeddouble746 enrolledStarted 2023-02Completion 2024-1250 sites · Argentina, United StatesAmgen

A Phase 3, Open-label, 52-week Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab (AMG 451) in Adolescent Subjects Aged ≥ 12 to < 18 Years With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Orbit)

NCT05633355Registry updated 2026-07-24·Phase 3·AMGN
Completed

Primary endpoint: Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (TESAEs)

Interventionalopen187 enrolledStarted 2023-01Completion 2025-0750 sites · Argentina, Australia, Brazil, Canada…Amgen

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)

NCT05651711Registry updated 2026-06-26·Phase 3·AMGN
Completed

Primary endpoint: Number of Participants Who Achieved Validated Investigator's Global Assessment for AD (vIGA-AD) 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24

InterventionalRandomizeddouble726 enrolledStarted 2022-12Completion 2024-0850 sites · United StatesAmgen

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)

NCT05398445Registry updated 2026-07-23·Phase 3·AMGN
Completed

Primary endpoint: Number of Participants Who Achieved Validated Investigator's Global Assessment for AD (vIGA-AD) 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24

InterventionalRandomizeddouble769 enrolledStarted 2022-05Completion 2025-0150 sites · United StatesAmgen