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Clinical Trials in the USA / NCT06136741
Active, not recruiting Phase 2

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

NCT06136741 · tracked via the Priya Life Science USA tracker
Sponsor
Nektar Therapeutics
Phase
Phase 2
Started
2023-11-15
Last updated
2026-08-21

Condition(s) studied

Moderate to Severe Atopic Dermatitis

Investigational drug(s) / intervention(s)

RezpegaldesleukinPlacebo

Rezpegaldesleukin: Pharmaceutical form: Injection solution Route of administration: subcutaneous

Placebo: Pharmaceutical form: Injection solution Route of administration: subcutaneous

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (107)

FacilityCityRegionStatus
Nektar Investigative Site Bryant Arkansas
Nektar Investigative Site Fountain Valley California
Nektar Investigative Site Los Angeles California
Nektar Investigative Site Los Angeles California
Nektar Investigative Site Los Angeles California
Nektar Investigative Site Santa Monica California
Nektar Investigative Site Hialeah Florida
Nektar Investigative Site Hollywood Florida
Nektar Investigative Site Miami Florida
Nektar Investigative Site Miami Lakes Florida
Nektar Investigative Site St. Petersburg Florida
Nektar Investigative Site Tampa Florida
Nektar Investigative Site Marietta Georgia
Nektar Investigative Site Clarksville Indiana
Nektar Investigative Site Indianapolis Indiana
Nektar Investigative Site Louisville Kentucky
Nektar Investigative Site Flint Michigan
Nektar Investigative Site Troy Michigan
Nektar Investigative Site Las Vegas Nevada
Nektar Investigative Site New York New York
Nektar Investigative Site Fairborn Ohio
Nektar Investigative Site Mayfield Heights Ohio
Nektar Investigative Site Murfreesboro Tennessee
Nektar Investigative Site Bellaire Texas
Nektar Investigative Site Cypress Texas
Nektar Investigative Site Frisco Texas
Nektar Investigative Site Spokane Washington
Nektar Investigative Site Spokane Washington
Nektar Investigative Site Darlinghurst New South Wales
Nektar Investigative Site Kogarah New South Wales
Nektar Investigative Site Westmead New South Wales
Nektar Investigative Site Woolloongabba Queensland
Nektar Investigative Site Campbelltown South Australia
Nektar Investigative Site East Melbourne Victoria
Nektar Investigative Site Melbourne Victoria
Nektar Investigative Site Sevlievo Gabrovo
Nektar Investigative Site Dupnitsa Kyustendil
Nektar Investigative Site Sofia Sofia-Grad
Nektar Investigative Site Sofia Sofia-Grad
Nektar Investigative Site Sofia Sofia-Grad

+ 67 more sites — see the full list on the official registry below.

More Nektar Therapeutics trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06136741 on ClinicalTrials.gov ↗ ← All trials in the USA