A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe AD (ROCKET-Outpost)

Amgen

Status and phase: Enrolling; Phase 3

Conditions: Atopic Dermatitis

Treatments: Combination Product: Rocatinlimab AI; Combination Product: Rocatinlimab Prefilled Syringe

Study type: Interventional

Funder types: Industry

Identifiers

NCT06224192

20230180

Details and patient eligibility

About

The primary objective of this study is to assess successful self-administration of rocatinlimab subcutaneous using devices for injection at home.

Enrollment: 150 estimated patients

Sex: All

Ages: 12 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 12 at Day 1.
• Diagnosis of AD according to American Academy of Dermatology (AAD) Consensus Criteria (2014) that has been present for at least 12 months.
• History of inadequate response to Topical Corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors [TCI]).
• Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) score ≥ 3 at screening and pre-randomization.
• Eczema Area and Severity Index (EASI) score ≥ 16 at initial at screening and pre-randomization.
• ≥ 10% body surface area (BSA) of AD involvement at screening and pre-randomization.

Exclusion criteria

• Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 pre-randomization.

• Treatment with any of the following medications or therapies within 5 half-lives prior to day 1 pre-randomization:

  1. Systemic corticosteroids
  2. Non-biologic, non-targeted systemic immunosuppressants
  3. Oral or Topical Janus kinase inhibitors

• Treatment with any of the following medications or therapies within 1 week before day 1 pre-randomization:

  1. Topical phosphodiesterase 4 (PDE4) inhibitors
  2. Other topical immunosuppressive agents (not including TCS/TCI)
  3. Combination topical agents containing any of the above components

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Rocatinlimab Dose 1 Prefilled Syringe (PFS)

Experimental group

Description:

Rocatinlimab will be self-administered subcutaneously using a PFS. Participants will receive rocatinlimab for 52 weeks.

Treatment:

Combination Product: Rocatinlimab Prefilled Syringe

Rocatinlimab Dose 2 PFS

Experimental group

Description:

Rocatinlimab will be self-administered subcutaneously using a PFS. Participants will receive rocatinlimab for 52 weeks.

Treatment:

Combination Product: Rocatinlimab Prefilled Syringe

Rocatinlimab Dose 2 Autoinjector (AI)

Experimental group

Description:

Rocatinlimab will be self-administered subcutaneously using an AI. Participants will received rocatinlimab for 52 weeks.

Treatment:

Combination Product: Rocatinlimab AI