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The trial is taking place at:
S

Sinclair Dermatology | East Melbourne, Australia

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

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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

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

Trial contacts and locations

197

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Central trial contact

Amgen Call Center

Data sourced from clinicaltrials.gov

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