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Active (not recruiting) Phase 2 NCT06136741

A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis

Phase 2 – studying effectiveness and dosage
Conditions: Moderate to Severe Atopic Dermatitis

Sponsor: Nektar Therapeutics

trial.available_in: БГ
Overview
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
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 invasive opportunistic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration. * Positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) at screening. * Severe concomitant illness that would in the Investigator's opinion inhibit the patient's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease. * Concurrent participation in any other investigational clinical study.
Locations 10
Australia (1)
Nektar Investigative Site
Darlinghurst , New South Wales
Bulgaria (1)
Nektar Investigative Site
Sevlievo , Gabrovo
Canada (1)
Nektar Investigative Site
Calgary , Alberta
Croatia (1)
Nektar Investigative Site 5701
Zagreb , City of Zagreb
Czech Republic (1)
Nektar Investigative Site
Brno
Germany (1)
Nektar Investigative Site
Augsburg , Bavaria
Hungary (1)
Nektar Investigative Site
Gyula , Bekes County
Poland (1)
Nektar Investigative Site
Wroclaw , Lower Silesian Voivodeship
Spain (1)
Nektar Investigative Site
Alicante
United States (1)
Nektar Investigative Site
Bryant , Arkansas
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
15.11.2023
Completion date
31.12.2026
Registry ID
NCT06136741
Source
anzctr
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