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Kaiser Permanente Los Angeles Medical Center | Department of Research and Evaluation

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A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE) (ROCKET-Ignite)

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Amgen

Status and phase

Active, not recruiting
Phase 3

Conditions

Atopic Dermatitis

Treatments

Drug: Rocatinlimab
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05398445
20210142

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.

Enrollment

769 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥ 18 years 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 to higher potency within 6 months (with or without topical calcineurin inhibitors [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 of any potency
    • TCI
    • Topical phosphodiesterase type 4 inhibitors
    • Other topical immunosuppressive agents

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

769 participants in 3 patient groups, including a placebo group

Arm A
Experimental group
Description:
Rocatinlimab Dose 1 every 4 weeks (Q4W) + loading dose at Week 2
Treatment:
Drug: Rocatinlimab
Arm B
Experimental group
Description:
Rocatinlimab Dose 2 Q4W + loading dose at Week 2
Treatment:
Drug: Rocatinlimab
Arm C
Placebo Comparator group
Description:
Placebo Q4W+ loading dose at Week 2
Treatment:
Drug: Placebo

Trial contacts and locations

202

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Central trial contact

Amgen Call Center

Data sourced from clinicaltrials.gov

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