A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With M… (NCT06136741) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis
United States396 participantsStarted 2023-11-15
Plain-language summary
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, an Induction Period of 16 weeks, a Maintenance Period from Week 16-Week 52, and a Posttreatment Follow-Up Period for an additional year up to approximately Week 104 for all patients. Patients with a response at Week 16 (end of induction therapy) will be re-randomized for the maintenance therapy period.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Adults (from at least 18 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:
* EASI of 16 or higher
* IGA of 3 or 4
* BSA of 10% or more
* 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:
* Prior use of systemic immune modulating therapies for AD (i.e., JAK inhibitors or biologics)
* Other skin conditions that would interfere with assessment of AD
* Treatment with a live (attenuated) immunization within 12 weeks prior to screening.
* Men and women (of reproductive potential) unwilling to use highly effective birth control and women who are pregnant or breastfeeding.
* Any malignancies or history of malignancies within 5 years prior to randomization (except for basal cell or squamous epithelial carcinomas of the skin that have been successfully treated with no evidence of metastatic disease for 3 years or cervical carcinoma in situ that has been successfully treated, with no evidence of recurrence within the 3 years prior to randomization).
* Known history of, or suspected, significant current immunosuppression, including history of invasi…
What they're measuring
1
Mean percent change in the Eczema Area and Severity Index (EASI) from baseline at Week 16