First OC Dermatology Research, Inc. | Fountain Valley, CA
Status and phase
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About
This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 4-arm study to assess the effect of pegylated-recombinant-human interleukin-2 (rezpegaldesleukin) in adult participants with moderate to severe atopic dermatitis.
The estimated duration is 15-35 days for screening and then up to approximately day 378 (last dose on day 280 + 98 days safety follow-up) for all patients. Patients with a response at Week 16 (end of induction therapy) will be re-randomized for the maintenance therapy period.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Adults (18 to 70 years of age) with AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer prior to screening.
AD disease severity at screening and randomization:
Documented history, within 6 months prior to the screening visit, of either inadequate response or inadvisability of topical treatments.
Able to complete patient questionnaires.
Able and willing to comply with requested study visits and procedures.
Able and willing to provide written informed consent.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
396 participants in 12 patient groups, including a placebo group
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Central trial contact
Nektar Recruitment
Data sourced from clinicaltrials.gov
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