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

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Moderate to Severe Atopic Dermatitis
• Intervention / Treatment: Drug: Rezpegaldesleukin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 396
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Nektar Investigative Site
    • Kogarah, New South Wales, Australia, 2217
      • Nektar Investigative Site
    • Westmead, New South Wales, Australia, 2145
      • Nektar Investigative Site
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Nektar Investigative Site
  • South Australia
    • Campbelltown, South Australia, Australia, 5074
      • Nektar Investigative Site
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Nektar Investigative Site
    • Melbourne, Victoria, Australia, 3004
      • Nektar Investigative Site
• Bulgaria
  • Lovech, Bulgaria, 5500
    • Nektar Investigative Site
  • Pleven, Bulgaria, 5800
    • Nektar Investigative Site
  • Sofia, Bulgaria, 1463
    • Nektar Investigative Site
  • Sofia, Bulgaria, 1510
    • Nektar Investigative Site
  • Gabrovo
    • Sevlievo, Gabrovo, Bulgaria, 5400
      • Nektar Investigative Site
  • Kyustendil
    • Dupnitsa, Kyustendil, Bulgaria, 2600
      • Nektar Investigative Site
  • Sofia-Grad
    • Sofia, Sofia-Grad, Bulgaria, 1407
      • Nektar Investigative Site
    • Sofia, Sofia-Grad, Bulgaria, 1431
      • Nektar Investigative Site
    • Sofia, Sofia-Grad, Bulgaria, 1592
      • Nektar Investigative Site
    • Sofia, Sofia-Grad, Bulgaria, 1784
      • Nektar Investigative Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Nektar Investigative Site
    • Edmonton, Alberta, Canada, T6H 4J8
      • Nektar Investigative Site
  • British Columbia
    • Kelowna, British Columbia, Canada, V1W 4V5
      • Nektar Investigative Site
    • Surrey, British Columbia, Canada, V3V 0C6
      • Nektar Investigative Site
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Nektar Investigative Site
    • Markham, Ontario, Canada, L3P 1X3
      • Nektar Investigative Site
    • Peterborough, Ontario, Canada, K9J 5K2
      • Nektar Investigative Site
    • Richmond Hill, Ontario, Canada, L4B 1A5
      • Nektar Investigative Site
    • Toronto, Ontario, Canada, M3H 5Y8
      • Nektar Investigative Site
    • Toronto, Ontario, Canada, M4W 2N2
      • Nektar Investigative Site
  • Quebec
    • Québec, Quebec, Canada, G1W 4R4
      • Nektar Investigative Site
• Croatia
  • Ivanić-Grad, Croatia, 10310
    • Nektar Investigative Site
  • City of Zagreb
    • Zagreb, City of Zagreb, Croatia, 10000
      • Nektar Investigative Site 5701
    • Zagreb, City of Zagreb, Croatia, 10000
      • Nektar Investigative Site 5703
• Czechia
  • Brno, Czechia, 602 00
    • Nektar Investigative Site
  • Pardubice, Czechia, 530 02
    • Nektar Investigative Site
  • Prague, Czechia, 100 34
    • Nektar Investigative Site
  • Prague, Czechia, 150 00
    • Nektar Investigative Site
• Germany
  • Berlin, Germany, 10789
    • Nektar Investigative Site
  • Berlin, Germany, 13353
    • Nektar Investigative Site
  • Darmstadt, Germany, 64283
    • Nektar Investigative Site
  • Frankfurt, Germany, 60590
    • Nektar Investigative Site
  • Lübeck, Germany, 23538
    • Nektar Investigative Site
  • München, Germany, 80337
    • Nektar Investigator Site
  • Bavaria
    • Augsburg, Bavaria, Germany, 86150
      • Nektar Investigative Site
    • Augsburg, Bavaria, Germany, 86179
      • Nektar Investigator Site
    • Erlangen, Bavaria, Germany, 91054
      • Nektar Investigative Site
  • Lower Saxony
    • Bad Bentheim, Lower Saxony, Germany, 48455
      • Nektar Investigative Site
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, 55131
      • Nektar Investigative Site
  • Saxony
    • Leipzig, Saxony, Germany, 4103
      • Nektar Investigative Site
• Hungary
  • Bekes County
    • Gyula, Bekes County, Hungary, 5700
      • Nektar Investigative Site
• Poland
  • Częstochowa, Poland, 42-202
    • Nektar Investigative Site
  • Iława, Poland, 14-200
    • Nektar Investigative Site
  • Katowice, Poland, 40-040
    • Nektar Investigative Site
  • Krakow, Poland, 30-033
    • Nektar Investigator Site
  • Krakow, Poland, 30-727
    • Nektar Investigative Site
  • Krakow, Poland, 31-011
    • Nektar Investigative Site
  • Lodz, Poland, 90-127
    • Nektar Investigative Site
  • Lodz, Poland, 90-436
    • Nektar Investigative Site
  • Poznan, Poland, 60-702
    • Nektar Investigative Site
  • Szczecin, Poland, 71-500
    • Nektar Investigative Site
  • Tarnów, Poland, 33-100
    • Nektar Investigative Site
  • Warsaw, Poland, 01-142
    • Nektar Investigative Site
  • Warsaw, Poland, 02-507
    • Nektar Investigative Site
  • Warsaw, Poland, 02-962
    • Nektar Investigative Site
  • Wroclaw, Poland, 50-566
    • Nektar Investigative Site
  • Wroclaw, Poland, 51-503
    • Nektar Investigative Site
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 50-220
      • Nektar Investigative Site
    • Wroclaw, Lower Silesian Voivodeship, Poland, 50-381
      • Nektar Investigative Site
    • Wroclaw, Lower Silesian Voivodeship, Poland, 51-685
      • Nektar Investigative Site
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 00-874
      • Nektar Investigative Site
    • Warsaw, Masovian Voivodeship, Poland, 02-672
      • Nektar Investigative Site
    • Warsaw, Masovian Voivodeship, Poland, 02-953
      • Nektar Investigative Site
  • Podkarpackie Voivodeship
    • Rzeszów, Podkarpackie Voivodeship, Poland, 35-055
      • Nektar Investigative Site
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-382
      • Nektar Investigative Site
    • Gdansk, Pomeranian Voivodeship, Poland, 80-546
      • Nektar Investigative Site
    • Gdynia, Pomeranian Voivodeship, Poland, 81-537
      • Nektar Investigative Site
• Spain
  • Alicante, Spain, 3010
    • Nektar Investigative Site
  • Córdoba, Spain, 14004
    • Nektar Investigative Site
  • Granada, Spain, 18014
    • Nektar Investigative Site
  • Seville, Spain, 41009
    • Nektar Investigative Site
  • Zaragoza, Spain, 50009
    • Nektar Investigative Site
• United States
  • Arkansas
    • Bryant, Arkansas, United States, 72022
      • Nektar Investigative Site
  • California
    • Fountain Valley, California, United States, 92708
      • Nektar Investigative Site
    • Los Angeles, California, United States, 90017
      • Nektar Investigative Site
    • Los Angeles, California, United States, 90025
      • Nektar Investigative Site
    • Los Angeles, California, United States, 90057
      • Nektar Investigative Site
    • Santa Monica, California, United States, 90404
      • Nektar Investigative Site
  • Florida
    • Hialeah, Florida, United States, 33016
      • Nektar Investigative Site
    • Hollywood, Florida, United States, 33021
      • Nektar Investigative Site
    • Miami, Florida, United States, 33173
      • Nektar Investigative Site
    • Miami Lakes, Florida, United States, 33014
      • Nektar Investigative Site
    • St. Petersburg, Florida, United States, 33705
      • Nektar Investigative Site
    • Tampa, Florida, United States, 33615
      • Nektar Investigative Site
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Nektar Investigative Site
  • Indiana
    • Clarksville, Indiana, United States, 47129
      • Nektar Investigative Site
    • Indianapolis, Indiana, United States, 46202
      • Nektar Investigative Site
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Nektar Investigative Site
  • Michigan
    • Flint, Michigan, United States, 48532
      • Nektar Investigative Site
    • Troy, Michigan, United States, 48084
      • Nektar Investigative Site
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Nektar Investigative Site
  • New York
    • New York, New York, United States, 10075
      • Nektar Investigative Site
  • Ohio
    • Fairborn, Ohio, United States, 45324
      • Nektar Investigative Site
    • Mayfield Heights, Ohio, United States, 44124
      • Nektar Investigative Site
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130
      • Nektar Investigative Site
  • Texas
    • Bellaire, Texas, United States, 77401
      • Nektar Investigative Site
    • Cypress, Texas, United States, 77429
      • Nektar Investigative Site
    • Frisco, Texas, United States, 75034
      • Nektar Investigative Site
  • Washington
    • Spokane, Washington, United States, 99202-1461
      • Nektar Investigative Site
    • Spokane, Washington, United States, 99202
      • Nektar Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; Rezpegaldesleukin Dose Regimen A every 2 weeks during the induction period	Drug: Rezpegaldesleukin; Pharmaceutical form: Injection solution Route of administration: subcutaneous; Other Names: NKTR-358; REZPEG; LY3471851 (formerly)
Experimental: Arm A1; Rezpegaldesleukin Dose Regimen A every 4 weeks during the maintenance period	Drug: Rezpegaldesleukin; Pharmaceutical form: Injection solution Route of administration: subcutaneous; Other Names: NKTR-358; REZPEG; LY3471851 (formerly)
Experimental: Arm A2; Rezpegaldesleukin Dose Regimen A every 12 weeks during the maintenance period	Drug: Rezpegaldesleukin; Pharmaceutical form: Injection solution Route of administration: subcutaneous; Other Names: NKTR-358; REZPEG; LY3471851 (formerly); Drug: Placebo; Pharmaceutical form: Injection solution Route of administration: subcutaneous
Experimental: Arm B; Rezpegaldesleukin Dose Regimen B every 4 weeks during the induction period	Drug: Rezpegaldesleukin; Pharmaceutical form: Injection solution Route of administration: subcutaneous; Other Names: NKTR-358; REZPEG; LY3471851 (formerly); Drug: Placebo; Pharmaceutical form: Injection solution Route of administration: subcutaneous
Experimental: Arm B1; Rezpegaldesleukin Dose Regimen B every 4 weeks during the maintenance period	Drug: Rezpegaldesleukin; Pharmaceutical form: Injection solution Route of administration: subcutaneous; Other Names: NKTR-358; REZPEG; LY3471851 (formerly)
Experimental: Arm B2; Rezpegaldesleukin Dose Regimen B every 12 weeks during the maintenance period	Drug: Rezpegaldesleukin; Pharmaceutical form: Injection solution Route of administration: subcutaneous; Other Names: NKTR-358; REZPEG; LY3471851 (formerly); Drug: Placebo; Pharmaceutical form: Injection solution Route of administration: subcutaneous
Experimental: Arm C; Rezpegaldesleukin Dose Regimen C every 2 weeks during the induction period	Drug: Rezpegaldesleukin; Pharmaceutical form: Injection solution Route of administration: subcutaneous; Other Names: NKTR-358; REZPEG; LY3471851 (formerly)
Experimental: Arm C1; Rezpegaldesleukin Dose Regimen C every 4 weeks during the maintenance period	Drug: Rezpegaldesleukin; Pharmaceutical form: Injection solution Route of administration: subcutaneous; Other Names: NKTR-358; REZPEG; LY3471851 (formerly)
Experimental: Arm C2; Rezpegaldesleukin Dose Regimen C every 12 weeks during the maintenance period	Drug: Rezpegaldesleukin; Pharmaceutical form: Injection solution Route of administration: subcutaneous; Other Names: NKTR-358; REZPEG; LY3471851 (formerly); Drug: Placebo; Pharmaceutical form: Injection solution Route of administration: subcutaneous
Placebo Comparator: Arm D; Placebo every 2 weeks during the induction period	Drug: Placebo; Pharmaceutical form: Injection solution Route of administration: subcutaneous
Placebo Comparator: Arm D1; Placebo every 4 weeks during the maintenance period	Drug: Placebo; Pharmaceutical form: Injection solution Route of administration: subcutaneous
Experimental: Escape Therapy (open-label); Rezpegaldesleukin Dose Regimen A every 2 weeks during the maintenance period	Drug: Rezpegaldesleukin; Pharmaceutical form: Injection solution Route of administration: subcutaneous; Other Names: NKTR-358; REZPEG; LY3471851 (formerly)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean percent change in the Eczema Area and Severity Index (EASI) from baseline at Week 16	The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.	Week 0 and Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients at week 16 achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 and at least a 2-point reduction from their baseline value	The vIGA-AD scale ranges from 0 to 4, with higher score indicating more severe atopic dermatitis.	Week 0 and Week 16
Proportion of patients at week 16 achieving a Eczema Area and Severity Index reduction of 75% relative to their baseline score (EASI-75)	The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.	Week 0 and Week 16
Proportion of patients at week 16 achieving a Eczema Area and Severity Index reduction of 90% relative to their baseline score (EASI-90)	The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.	Week 0 and Week 16
Proportion of patients at week 16 achieving a Eczema Area and Severity Index reduction of 50% relative to their baseline score (EASI-50)	The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.	Week 0 and Week 16
Proportion of patients at week 16 achieving a 4-point or greater improvement in Itch numerical rating scale (NRS) in the subset of patients with a 4-point or greater Itch NRS at baseline	The itch NRS goes from 0 to 10, with higher score indicating more severe itch.	Week 0 and Week 16
Proportion of patients at week 16 achieving a SCORing Atopic Dermatitis Index (SCORAD) reduction of 75% from their baseline value	The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.	Week 0 and Week 16
Proportion of patients at week 16 achieving a SCORAD reduction of 50% from their baseline value	The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.	Week 0 and Week 16
Mean change from baseline over the period between week 0 and week 104 in Eczema Area and Severity Index (EASI)	The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.	From Week 0 through Week 104
Mean percent change from baseline over the period between week 0 and week 104 in Eczema Area and Severity Index (EASI)	The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.	From Week 0 through Week 104
Mean change from baseline over the period between week 0 and week 104 in SCORAD	The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.	From Week 0 through Week 104
Mean percent change from baseline over the period between week 0 and week 104 in SCORAD	The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.	From Week 0 through Week 104
Mean change from baseline over the period between week 0 and week 104 in body surface area (BSA) involvement		From Week 0 through Week 104
Mean percent change from baseline over the period between week 0 and week 104 in body surface area (BSA) involvement		From Week 0 through Week 104
Rezpegaldesleukin plasma concentration assessed throughout the study		Through end of study (week 104)
Incidence of Serious Adverse Events (SAEs)		Through end of study (week 104)
Incidence of Treatment Emergent Adverse Events (TEAEs)		Through end of study (week 104)

Collaborators and Investigators

• Sponsor: Nektar Therapeutics
• Investigators: Study Director: Study Director, Nektar Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Actual): May 6, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema; Amino Acids, Peptides, and Proteins; Proteins; Hydrolases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Carrier Proteins; rho GTP-Binding Proteins; Monomeric GTP-Binding Proteins; GTP-Binding Proteins; GTP Phosphohydrolases; Acid Anhydride Hydrolases; rhoA GTP-Binding Protein
• Other Study ID Numbers: 23-358-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No