ROCKET-SHUTTLE: A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)
Study Details
Study Description
Brief Summary
The coprimary objectives of the study are to:
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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).
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To 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Rocatinlimab Dose 1 + TCS/TCI Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks + TCS/TCI + loading dose at Week 2. |
Drug: Rocatinlimab
Subcutaneous (SC) injection
Other Names:
|
| Experimental: Rocatinlimab Dose 2 + TCS/TCI Rocatinlimab Dose 2 Q4W for 24 weeks + TCS/TCI + loading dose at Week 2. |
Drug: Rocatinlimab
Subcutaneous (SC) injection
Other Names:
|
| Placebo Comparator: Placebo + TCS/TCI Placebo Q4W for 24 weeks + TCS/TCI + loading dose at Week 2. |
Other: Placebo
SC injection
|
Outcome Measures
Primary Outcome Measures
- Achievement of a vIGA-AD Score of 0 or 1 with a ≥2 Point Reduction From Baseline at Week 24 [Baseline, Week 24]
- Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24 [Baseline, Week 24]
Secondary Outcome Measures
- Achievement of EASI 75 at Week 16 [Baseline, Week 16]
- Achievement of vIGA-AD 0/1 at Week 16 [Baseline, Week 16]
- Achievement of a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus Numeric Rating Scale (NRS) Score at Week 16 in Participants with Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4 [Baseline, Week 16]
- Achievement of a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Participants with Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4 [Baseline, Week 24]
- Achievement of ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24 [Baseline, Week 24]
- Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 [Baseline, Week 24]
- Achievement of vIGA-AD 0/1 and Presence of Barely Perceptible Erythema or No Erythema at Week 24 [Baseline, Week 24]
- Achievement of a Facial AD Severity Score (FASS) of Clear at Week 24 for Participants with Facial AD at Baseline [Baseline, Week 24]
- Achievement of a Hand AD Severity Score (HASS) of Clear at Week 24 for Participants with Hand AD at Baseline [Baseline, Week 24]
- Achievement of a Genital AD Severity Score (GASS) of Clear at Week 24 for Participants with Genital AD at Baseline [Baseline, Week 24]
- Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16 [Baseline, Week 16]
- Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 [Baseline, Week 24]
- Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16 [Baseline, Week 16]
- Change From Baseline in SCORAD Itch VAS Score at Week 24 [Baseline, Week 24]
- Achievement of ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI Score ≥ 4 [Baseline, Week 24]
- Change From Baseline in DLQI Score at Week 24 [Baseline, Week 24]
- Achievement of a ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants with Baseline POEM Score ≥ 4 [Baseline, Week 24]
- Change From Baseline in POEM Score at Week 24 [Baseline, Week 24]
- Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 [Baseline, Week 16]
- Change From Baseline in Weekly Average of Sleep Disturbance NRS Score at Week 24 [Baseline, Week 24]
- Achievement of a Hospital Anxiety and Depression Scale (HADS)-anxiety Subscale Score < 8 at Week 24 in Participants with Baseline HADS-anxiety Subscale Score ≥ 8 [Baseline, Week 24]
- Achievement of a HADS-depression Subscale Score < 8 at Week 24 in Participants with Baseline HADS-depression Subscale Score ≥ 8 [Baseline, Week 24]
- Change From Baseline in HADS-anxiety Subscale Score at Week 24 [Baseline, Week 24]
- Change From Baseline in HADS-depression Subscale Score at Week 24 [Baseline, Week 24]
- Achievement of a ≥ 8.7-point Reduction from Baseline in SCORAD Score at Week 24 in Participants with Baseline SCORAD Score ≥ 8.7 [Baseline, Week 24]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years with a diagnosis of AD according to the AAD (American Academy of Dermatology) Consensus Criteria (2014) present for at least 6 months
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History of inadequate response to TCS of medium or higher potency within 6 months (with or without TCI)
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EASI score ≥16
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vIGA-AD score ≥3
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≥10% body surface area (BSA) of AD involvement
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Worst pruritus numerical rating scale ≥ 4
Exclusion Criteria:
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Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1
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Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:
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Systemic corticosteroids
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Systemic immunosuppressants
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Phototherapy
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Janus kinase inhibitors
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Treatment with any of the following medications or therapies within 1 week, prior to
Day 1:
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TCS
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TCI
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Anti-pruritic agents
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Topical phosphodiesterase type 4 inhibitors
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Other topical immunosuppressive agents
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Combination topical agents including TCS of any potency or TCI, PDE4 inhibitors, or other topical immunosuppressive agents
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 20210144
- 2022-000930-41