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ACTIVE NOT RECRUITING

NCT06136741

PHASE2

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

Sponsor: Nektar Therapeutics

View on ClinicalTrials.gov

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.

Official title: A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis (REZOLVE-AD)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

396

Start Date

2023-11-15

Completion Date

2026-12-31

Last Updated

2026-03-31

Healthy Volunteers

Conditions

Moderate to Severe Atopic Dermatitis

Interventions

DRUG

Rezpegaldesleukin

Pharmaceutical form: Injection solution Route of administration: subcutaneous

DRUG

Placebo

Pharmaceutical form: Injection solution Route of administration: subcutaneous

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 (107)

Nektar Investigative Site

Bryant, Arkansas, United States

Nektar Investigative Site

Fountain Valley, California, United States

Nektar Investigative Site

Los Angeles, California, United States

Nektar Investigative Site

Los Angeles, California, United States

Nektar Investigative Site

Los Angeles, California, United States

Nektar Investigative Site

Santa Monica, California, United States

Nektar Investigative Site

Hialeah, Florida, United States

Nektar Investigative Site

Hollywood, Florida, United States

Nektar Investigative Site

Miami, Florida, United States

Nektar Investigative Site

Miami Lakes, Florida, United States

Nektar Investigative Site

St. Petersburg, Florida, United States

Nektar Investigative Site

Tampa, Florida, United States

Nektar Investigative Site

Marietta, Georgia, United States

Nektar Investigative Site

Clarksville, Indiana, United States

Nektar Investigative Site

Indianapolis, Indiana, United States

Nektar Investigative Site

Louisville, Kentucky, United States

Nektar Investigative Site

Flint, Michigan, United States

Nektar Investigative Site

Troy, Michigan, United States

Nektar Investigative Site

Las Vegas, Nevada, United States

Nektar Investigative Site

New York, New York, United States

Nektar Investigative Site

Fairborn, Ohio, United States

Nektar Investigative Site

Mayfield Heights, Ohio, United States

Nektar Investigative Site

Murfreesboro, Tennessee, United States

Nektar Investigative Site

Bellaire, Texas, United States

Nektar Investigative Site

Cypress, Texas, United States

Nektar Investigative Site

Frisco, Texas, United States

Nektar Investigative Site

Spokane, Washington, United States

Nektar Investigative Site

Spokane, Washington, United States

Nektar Investigative Site

Darlinghurst, New South Wales, Australia

Nektar Investigative Site

Kogarah, New South Wales, Australia

Nektar Investigative Site

Westmead, New South Wales, Australia

Nektar Investigative Site

Woolloongabba, Queensland, Australia

Nektar Investigative Site

Campbelltown, South Australia, Australia

Nektar Investigative Site

East Melbourne, Victoria, Australia

Nektar Investigative Site

Melbourne, Victoria, Australia

Nektar Investigative Site

Sevlievo, Gabrovo, Bulgaria

Nektar Investigative Site

Dupnitsa, Kyustendil, Bulgaria

Nektar Investigative Site

Sofia, Sofia-Grad, Bulgaria

Nektar Investigative Site

Sofia, Sofia-Grad, Bulgaria

Nektar Investigative Site

Sofia, Sofia-Grad, Bulgaria

Nektar Investigative Site

Sofia, Sofia-Grad, Bulgaria

Nektar Investigative Site

Lovech, Bulgaria

Nektar Investigative Site

Pleven, Bulgaria

Nektar Investigative Site

Sofia, Bulgaria

Nektar Investigative Site

Sofia, Bulgaria

Nektar Investigative Site

Calgary, Alberta, Canada

Nektar Investigative Site

Edmonton, Alberta, Canada

Nektar Investigative Site

Kelowna, British Columbia, Canada

Nektar Investigative Site

Surrey, British Columbia, Canada

Nektar Investigative Site

Barrie, Ontario, Canada

Nektar Investigative Site

Markham, Ontario, Canada

Nektar Investigative Site

Peterborough, Ontario, Canada

Nektar Investigative Site

Richmond Hill, Ontario, Canada

Nektar Investigative Site

Toronto, Ontario, Canada

Nektar Investigative Site

Toronto, Ontario, Canada

Nektar Investigative Site

Québec, Quebec, Canada

Nektar Investigative Site 5701

Zagreb, City of Zagreb, Croatia

Nektar Investigative Site 5703

Zagreb, City of Zagreb, Croatia

Nektar Investigative Site

Ivanić-Grad, Croatia

Nektar Investigative Site

Brno, Czechia

Nektar Investigative Site

Pardubice, Czechia

Nektar Investigative Site

Prague, Czechia

Nektar Investigative Site

Prague, Czechia

Nektar Investigative Site

Augsburg, Bavaria, Germany

Nektar Investigator Site

Augsburg, Bavaria, Germany

Nektar Investigative Site

Erlangen, Bavaria, Germany

Nektar Investigative Site

Bad Bentheim, Lower Saxony, Germany

Nektar Investigative Site

Mainz, Rhineland-Palatinate, Germany

Nektar Investigative Site

Leipzig, Saxony, Germany

Nektar Investigative Site

Berlin, Germany

Nektar Investigative Site

Berlin, Germany

Nektar Investigative Site

Darmstadt, Germany

Nektar Investigative Site

Frankfurt, Germany

Nektar Investigative Site

Lübeck, Germany

Nektar Investigator Site

München, Germany

Nektar Investigative Site

Gyula, Bekes County, Hungary

Nektar Investigative Site

Wroclaw, Lower Silesian Voivodeship, Poland

Nektar Investigative Site

Wroclaw, Lower Silesian Voivodeship, Poland

Nektar Investigative Site

Wroclaw, Lower Silesian Voivodeship, Poland

Nektar Investigative Site

Warsaw, Masovian Voivodeship, Poland

Nektar Investigative Site

Warsaw, Masovian Voivodeship, Poland

Nektar Investigative Site

Warsaw, Masovian Voivodeship, Poland

Nektar Investigative Site

Rzeszów, Podkarpackie Voivodeship, Poland

Nektar Investigative Site

Gdansk, Pomeranian Voivodeship, Poland

Nektar Investigative Site

Gdansk, Pomeranian Voivodeship, Poland

Nektar Investigative Site

Gdynia, Pomeranian Voivodeship, Poland

Nektar Investigative Site

Częstochowa, Poland

Nektar Investigative Site

Iława, Poland

Nektar Investigative Site

Katowice, Poland

Nektar Investigator Site

Krakow, Poland

Nektar Investigative Site

Krakow, Poland

Nektar Investigative Site

Krakow, Poland

Nektar Investigative Site

Lodz, Poland

Nektar Investigative Site

Lodz, Poland

Nektar Investigative Site

Poznan, Poland

Nektar Investigative Site

Szczecin, Poland

Nektar Investigative Site

Tarnów, Poland

Nektar Investigative Site

Warsaw, Poland

Nektar Investigative Site

Warsaw, Poland

Nektar Investigative Site

Warsaw, Poland

Nektar Investigative Site

Wroclaw, Poland

Nektar Investigative Site

Wroclaw, Poland

Nektar Investigative Site

Alicante, Spain

Nektar Investigative Site

Córdoba, Spain

Nektar Investigative Site

Granada, Spain

Nektar Investigative Site

Seville, Spain

Nektar Investigative Site

Zaragoza, Spain

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (107)