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

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Amgen

Status and phase

Enrolling
Phase 3

Conditions

Atopic Dermatitis

Treatments

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

100 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.

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)

100 participants in 2 patient groups

Rocatinlimab Dose 1
Experimental group
Description:
Rocatinlimab will be self-administered subcutaneously using a prefilled syringe (PFS). Participants will receive rocatinlimab every 4 weeks (Q4W) for 52 weeks with a loading dose at week 2.
Treatment:
Combination Product: Rocatinlimab Prefilled Syringe
Rocatinlimab Dose 2
Experimental group
Description:
Rocatinlimab will be self-administered subcutaneously using a PFS. Participants will receive rocatinlimab Q4W for 52 weeks with a loading dose at week 2.
Treatment:
Combination Product: Rocatinlimab Prefilled Syringe

Trial contacts and locations

32

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Central trial contact

Amgen Call Center

Data sourced from clinicaltrials.gov

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