A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)

Phase 3

Completed

Brief Summary: The primary objectives of this study are to:

* estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-tetanus response at Week 24

* estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-meningococcal response at Week 24

Recruitment & Eligibility

Inclusion Criteria

Age ≥ 18 years to 54 years with a diagnosis of AD according to the American Academy of Dermatology (AAD) Consensus Criteria (2014) present for at least 12 months
History of inadequate response to topical corticosteroids (TCS) of medium, high, or higher potency (with or without topical calcineurin inhibitors)
Subjects with previous systemic treatment for AD are also considered as inadequate responders to topical treatments and are potentially eligible to be included in the study after appropriate washout.
Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score ≥ 3

Exclusion Criteria

Treatment with a biologic 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
- Systemic immunosuppressants
- Phototherapy
- Janus kinase inhibitors
Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
- TCS of any potency
- Topical calcineurin inhibitors (TCI)
- Topical Phosphodiesterase-4 inhibitors (PDE4)
- Other topical immunosuppressive agents
- Combination topical agents containing a corticosteroid or calcineurin inhibiting component, PDE4 inhibitors, or other topical immunosuppressive agents
Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 pre-randomization.
Treatment with any meningococcal vaccine within 1 year prior to screening, or treatment with any tetanus-, diphtheria-, or pertussis containing vaccine within 5 years prior to screening

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
Rocatinlimab	Rocatinlimab	Rocatinlimab every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.

Primary Outcome Measures

Name	Time	Method
Number of Participants with a Positive Anti-tetanus Response	Week 20 to week 24
Number of Participants with a Positive Anti-meningococcal Response	Week 20 to week 24

Secondary Outcome Measures

Name	Time	Method

Locations (85): Affiliated Dermatology
🇺🇸
Scottsdale, Arizona, United States
Center for Dermatology and Plastic Surgery
🇺🇸
Scottsdale, Arizona, United States
Scottsdale Clinical Trials
🇺🇸
Scottsdale, Arizona, United States
Medical Advancement Centers of Arizona
🇺🇸
Tempe, Arizona, United States
Little Rock Allergy and Asthma Clinical Research Center
🇺🇸
Little Rock, Arkansas, United States
Kern Research Inc
🇺🇸
Bakersfield, California, United States
Hope Clinical Research LLC
🇺🇸
Canoga Park, California, United States
Doc1 Healthcare Systems
🇺🇸
Chino, California, United States
310 Clinical Research
🇺🇸
Inglewood, California, United States
Chemidox Clinical Trials Incorporated
🇺🇸
Lancaster, California, United States
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Affiliated Dermatology
🇺🇸Scottsdale, Arizona, United States