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

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 (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
  • Combination topical agents including TCS of any potency, TCI, PDE4 inhibitors, or other topical immunosuppressive agents

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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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