A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE)

Amgen

Status and phase: Active, not recruiting; Phase 3

Conditions: Atopic Dermatitis

Treatments: Other: Placebo; Drug: Rocatinlimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05724199

2022-501585-22 (Registry Identifier)

20210144

Details and patient eligibility

About

The coprimary objectives of the study are to:

• evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™).
• evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI at Week 24, assessed using Eczema Area and Severity Index (EASI).

Enrollment: 746 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 (American Academy of Dermatology) Consensus Criteria (2014) present for at least 12 months
• History of inadequate response to TCS of medium or higher potency (with or without 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
  • Nonbiologic, non-targeted Systemic immunosuppressants
  • Phototherapy
  • Janus kinase inhibitors

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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746 participants in 3 patient groups, including a placebo group

Rocatinlimab Dose 1 + TCS/TCI

Experimental group

Description:

Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks + TCS/TCI + loading dose at Week 2.

Treatment:

Drug: Rocatinlimab

Rocatinlimab Dose 2 + TCS/TCI

Experimental group

Description:

Rocatinlimab Dose 2 Q4W for 24 weeks + TCS/TCI + loading dose at Week 2.

Treatment:

Drug: Rocatinlimab

Placebo + TCS/TCI

Placebo Comparator group

Description:

Placebo Q4W for 24 weeks + TCS/TCI + loading dose at Week 2.

Treatment:

Other: Placebo