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Sponsor ID
20210158

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

Sponsor ID
20210158
Clinicaltrials.gov ID
NCT05899816
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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

Additional Study Details

Phase
Phase 3
Product
Rocatinlimab
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
221
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants with a Positive Anti-tetanus Response

Timeframe: Week 20 to week 24

Number of Participants with a Positive Anti-meningococcal Response

Timeframe: Week 20 to week 24

Secondary Outcome Measures
Not Available

Study Documents

Plain Language Summary of Results
Available Language(s): English, Spanish (United States), English (Canada), French (Canadian)
Download Document(s)

Locations

Location
Status
Contact Us
Location
Wolverine Clinical Trials
Tustin, CA, United States, 92780
Status
Recruiting
Location
Hope Clinical Research LLC
Canoga Park, CA, United States, 91303
Status
Recruiting
Location
Integrative Skin Science and Research
Sacramento, CA, United States, 95815
Status
Recruiting
Location
Dermatologic Surgery Specialists
Macon, GA, United States, 31217
Status
Recruiting
Location
Excel Clinical Research
Las Vegas, NV, United States, 89109
Status
Recruiting
Location
Long Beach Research Institute
Long Beach, CA, United States, 90805
Status
Recruiting
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Study Info
Age
18 - 54 Years
Condition
  • Atopic Dermatitis
    • Sex
    All
    Trial Dates
    Jun 2023 - Aug 2024
    Inclusion and Exclusion Criteria
    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: o Systemic corticosteroids o Systemic immunosuppressants o Phototherapy o Janus kinase inhibitors • Treatment with any of the following medications or therapies within 1 week, prior to Day 1: o TCS of any potency o Topical calcineurin inhibitors (TCI) o Topical Phosphodiesterase-4 inhibitors (PDE4) o Other topical immunosuppressive agents o 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