The trial is taking place at:
S

Somnos Clinical Research | Lincoln, NE

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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)

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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

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

Trial contacts and locations

235

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Central trial contact

Amgen Call Center

Data sourced from clinicaltrials.gov

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