Recruiting adults age 18 to 54 years with a diagnosis of atopic dermatitis (AD) that has been present for at least 6 months, to participate in this clinical research trial. Must have a history of inadequate response to topical corticosteroids of medium-potency or high-potency, or for whom topical treatments are otherwise medically inadvisable. Moderate to severe AD at initial screening and day 1 pre-randomization, is also required.
Participants will receive investigational treatment (active study drug) or placebo, via subcutaneous injection. At Week 20, tetanus and meningococcal vaccines will be administered to each participant. Study treatment and study-related assessments will be provided at no cost. Reimbursement for study-related expenses may be provided.
Study participation will last about 40 weeks and involve about 10 visits to the study centre.
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Last Update Posted: December 10, 2023
NCT05899816
Amgen
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
Condition or Disease:
Atopic Dermatitis
Intervention/Treatment:
Drug: RocatinlimabPhase:
Phase 3
Ages Eligible for Study:
18 Years and 54 Years (Adult)
Sexes Eligible for Study:
All
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
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