A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

Amgen

Status and phase: Active, not recruiting; Phase 3

Conditions: Atopic Dermatitis

Treatments: Other: Placebo; Drug: Rocatinlimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05651711

20210143

2022-501538-44 (Other Identifier)

Details and patient eligibility

About

The co-primary objectives of the study are to:

• Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD).
• Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Eczema Area and Severity Index (EASI).

Enrollment: 726 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years (or ≥ legal adult age within the country if it is older than 18 years at signing of informed consent) with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months
• History of inadequate response to TCS (Topical Corticosteroid) of medium or higher potency (with or without topical calcineurin inhibitors [TCI]) as appropriate or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
• 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
  • Oral or topical Janus kinase inhibitors

• Treatment with any of the following medications or therapies within 1 week, prior to Day 1:

  • TCS of any potency
  • TCI
  • Topical phosphodiesterase type 4 (PDE4) inhibitors
  • Other topical immunosuppressive agents
  • Combination agents including TCS of any potency or TCI, PDE4 inhibitors, or other immunosuppressive agents

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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726 participants in 2 patient groups, including a placebo group

Rocatinlimab

Experimental group

Description:

Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.

Treatment:

Drug: Rocatinlimab

Placebo

Placebo Comparator group

Description:

Placebo Q4W for 24 weeks with a loading dose at Week 2.

Treatment:

Other: Placebo