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

NCT06136741 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 23-358-05
• Study Type: interventional
• Target: 396
• Locations: 10 countries
• Sites: 107

Brief 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.

Conditions

Moderate to Severe Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• 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

  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)

  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)

  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)

  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

  Week 0 and Week 16

Study Arms (12)

Arm A

EXPERIMENTAL

Rezpegaldesleukin Dose Regimen A every 2 weeks during the induction period

Drug: Rezpegaldesleukin

Arm A1

EXPERIMENTAL

Rezpegaldesleukin Dose Regimen A every 4 weeks during the maintenance period

Drug: Rezpegaldesleukin

Arm A2

EXPERIMENTAL

Rezpegaldesleukin Dose Regimen A every 12 weeks during the maintenance period

Drug: Rezpegaldesleukin; Drug: Placebo

Arm B

EXPERIMENTAL

Rezpegaldesleukin Dose Regimen B every 4 weeks during the induction period

Drug: Rezpegaldesleukin; Drug: Placebo

Arm B1

EXPERIMENTAL

Rezpegaldesleukin Dose Regimen B every 4 weeks during the maintenance period

Drug: Rezpegaldesleukin

Arm B2

EXPERIMENTAL

Rezpegaldesleukin Dose Regimen B every 12 weeks during the maintenance period

Drug: Rezpegaldesleukin; Drug: Placebo

Arm C

EXPERIMENTAL

Rezpegaldesleukin Dose Regimen C every 2 weeks during the induction period

Drug: Rezpegaldesleukin

Arm C1

EXPERIMENTAL

Rezpegaldesleukin Dose Regimen C every 4 weeks during the maintenance period

Drug: Rezpegaldesleukin

Arm C2

EXPERIMENTAL

Rezpegaldesleukin Dose Regimen C every 12 weeks during the maintenance period

Drug: Rezpegaldesleukin; Drug: Placebo

Arm D

PLACEBO COMPARATOR

Placebo every 2 weeks during the induction period

Drug: Placebo

Arm D1

PLACEBO COMPARATOR

Placebo every 4 weeks during the maintenance period

Drug: Placebo

Escape Therapy (open-label)

EXPERIMENTAL

Rezpegaldesleukin Dose Regimen A every 2 weeks during the maintenance period

Drug: Rezpegaldesleukin

Interventions

Rezpegaldesleukin DRUG

Pharmaceutical form: Injection solution Route of administration: subcutaneous

Also known as: NKTR-358, REZPEG, LY3471851 (formerly)

Arm A; Arm A1; Arm A2; Arm B; Arm B1; Arm B2; Arm C; Arm C1; Arm C2; Escape Therapy (open-label)

Placebo DRUG

Pharmaceutical form: Injection solution Route of administration: subcutaneous

Arm A2; Arm B; Arm B2; Arm C2; Arm D; Arm D1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nektar Therapeutics: lead

Study Sites (107)

Nektar Investigative Site

Bryant, Arkansas, 72022, United States

Location

Nektar Investigative Site

Fountain Valley, California, 92708, United States

Location

Nektar Investigative Site

Los Angeles, California, 90017, United States

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Nektar Investigative Site

Los Angeles, California, 90025, United States

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Nektar Investigative Site

Los Angeles, California, 90057, United States

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Nektar Investigative Site

Santa Monica, California, 90404, United States

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Nektar Investigative Site

Hialeah, Florida, 33016, United States

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Nektar Investigative Site

Hollywood, Florida, 33021, United States

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Nektar Investigative Site

Miami, Florida, 33173, United States

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Nektar Investigative Site

Miami Lakes, Florida, 33014, United States

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Nektar Investigative Site

St. Petersburg, Florida, 33705, United States

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Nektar Investigative Site

Tampa, Florida, 33615, United States

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Nektar Investigative Site

Marietta, Georgia, 30060, United States

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Nektar Investigative Site

Clarksville, Indiana, 47129, United States

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Nektar Investigative Site

Indianapolis, Indiana, 46202, United States

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Nektar Investigative Site

Louisville, Kentucky, 40241, United States

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Nektar Investigative Site

Flint, Michigan, 48532, United States

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Nektar Investigative Site

Troy, Michigan, 48084, United States

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Nektar Investigative Site

Las Vegas, Nevada, 89106, United States

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Nektar Investigative Site

New York, New York, 10075, United States

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Nektar Investigative Site

Fairborn, Ohio, 45324, United States

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Nektar Investigative Site

Mayfield Heights, Ohio, 44124, United States

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Nektar Investigative Site

Murfreesboro, Tennessee, 37130, United States

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Nektar Investigative Site

Bellaire, Texas, 77401, United States

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Nektar Investigative Site

Cypress, Texas, 77429, United States

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Nektar Investigative Site

Frisco, Texas, 75034, United States

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Nektar Investigative Site

Spokane, Washington, 99202-1461, United States

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Nektar Investigative Site

Spokane, Washington, 99202, United States

Location

Nektar Investigative Site

Darlinghurst, New South Wales, 2010, Australia

Location

Nektar Investigative Site

Kogarah, New South Wales, 2217, Australia

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Nektar Investigative Site

Westmead, New South Wales, 2145, Australia

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Nektar Investigative Site

Woolloongabba, Queensland, 4102, Australia

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Nektar Investigative Site

Campbelltown, South Australia, 5074, Australia

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Nektar Investigative Site

East Melbourne, Victoria, 3002, Australia

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Nektar Investigative Site

Melbourne, Victoria, 3004, Australia

Location

Nektar Investigative Site

Sevlievo, Gabrovo, 5400, Bulgaria

Location

Nektar Investigative Site

Dupnitsa, Kyustendil, 2600, Bulgaria

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Nektar Investigative Site

Sofia, Sofia-Grad, 1407, Bulgaria

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Nektar Investigative Site

Sofia, Sofia-Grad, 1431, Bulgaria

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Nektar Investigative Site

Sofia, Sofia-Grad, 1592, Bulgaria

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Nektar Investigative Site

Sofia, Sofia-Grad, 1784, Bulgaria

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Nektar Investigative Site

Lovech, 5500, Bulgaria

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Nektar Investigative Site

Pleven, 5800, Bulgaria

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Nektar Investigative Site

Sofia, 1463, Bulgaria

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Nektar Investigative Site

Sofia, 1510, Bulgaria

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Nektar Investigative Site

Calgary, Alberta, T2J 7E1, Canada

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Nektar Investigative Site

Edmonton, Alberta, T6H 4J8, Canada

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Nektar Investigative Site

Kelowna, British Columbia, V1W 4V5, Canada

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Nektar Investigative Site

Surrey, British Columbia, V3V 0C6, Canada

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Nektar Investigative Site

Barrie, Ontario, L4M 7G1, Canada

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Nektar Investigative Site

Markham, Ontario, L3P 1X3, Canada

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Nektar Investigative Site

Peterborough, Ontario, K9J 5K2, Canada

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Nektar Investigative Site

Richmond Hill, Ontario, L4B 1A5, Canada

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Nektar Investigative Site

Toronto, Ontario, M3H 5Y8, Canada

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Nektar Investigative Site

Toronto, Ontario, M4W 2N2, Canada

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Nektar Investigative Site

Québec, Quebec, G1W 4R4, Canada

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Nektar Investigative Site 5701

Zagreb, City of Zagreb, 10000, Croatia

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Nektar Investigative Site 5703

Zagreb, City of Zagreb, 10000, Croatia

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Nektar Investigative Site

Ivanić-Grad, 10310, Croatia

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Nektar Investigative Site

Brno, 602 00, Czechia

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Nektar Investigative Site

Pardubice, 530 02, Czechia

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Nektar Investigative Site

Prague, 100 34, Czechia

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Nektar Investigative Site

Prague, 150 00, Czechia

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Nektar Investigative Site

Augsburg, Bavaria, 86150, Germany

Location

Nektar Investigator Site

Augsburg, Bavaria, 86179, Germany

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Nektar Investigative Site

Erlangen, Bavaria, 91054, Germany

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Nektar Investigative Site

Bad Bentheim, Lower Saxony, 48455, Germany

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Nektar Investigative Site

Mainz, Rhineland-Palatinate, 55131, Germany

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Nektar Investigative Site

Leipzig, Saxony, 4103, Germany

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Nektar Investigative Site

Berlin, 10789, Germany

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Nektar Investigative Site

Berlin, 13353, Germany

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Nektar Investigative Site

Darmstadt, 64283, Germany

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Nektar Investigative Site

Frankfurt, 60590, Germany

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Nektar Investigative Site

Lübeck, 23538, Germany

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Nektar Investigator Site

München, 80337, Germany

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Nektar Investigative Site

Gyula, Bekes County, 5700, Hungary

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Nektar Investigative Site

Wroclaw, Lower Silesian Voivodeship, 50-220, Poland

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Nektar Investigative Site

Wroclaw, Lower Silesian Voivodeship, 50-381, Poland

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Nektar Investigative Site

Wroclaw, Lower Silesian Voivodeship, 51-685, Poland

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Nektar Investigative Site

Warsaw, Masovian Voivodeship, 00-874, Poland

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Nektar Investigative Site

Warsaw, Masovian Voivodeship, 02-672, Poland

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Nektar Investigative Site

Warsaw, Masovian Voivodeship, 02-953, Poland

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Nektar Investigative Site

Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

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Nektar Investigative Site

Gdansk, Pomeranian Voivodeship, 80-382, Poland

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Nektar Investigative Site

Gdansk, Pomeranian Voivodeship, 80-546, Poland

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Nektar Investigative Site

Gdynia, Pomeranian Voivodeship, 81-537, Poland

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Nektar Investigative Site

Częstochowa, 42-202, Poland

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Nektar Investigative Site

Iława, 14-200, Poland

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Nektar Investigative Site

Katowice, 40-040, Poland

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Nektar Investigator Site

Krakow, 30-033, Poland

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Nektar Investigative Site

Krakow, 30-727, Poland

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Nektar Investigative Site

Krakow, 31-011, Poland

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Nektar Investigative Site

Lodz, 90-127, Poland

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Nektar Investigative Site

Lodz, 90-436, Poland

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Nektar Investigative Site

Poznan, 60-702, Poland

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Nektar Investigative Site

Szczecin, 71-500, Poland

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Nektar Investigative Site

Tarnów, 33-100, Poland

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Nektar Investigative Site

Warsaw, 01-142, Poland

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Nektar Investigative Site

Warsaw, 02-507, Poland

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Nektar Investigative Site

Warsaw, 02-962, Poland

Location

Nektar Investigative Site

Wroclaw, 50-566, Poland

Location

Nektar Investigative Site

Wroclaw, 51-503, Poland

Location

Nektar Investigative Site

Alicante, 3010, Spain

Location

Nektar Investigative Site

Córdoba, 14004, Spain

Location

Nektar Investigative Site

Granada, 18014, Spain

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Nektar Investigative Site

Seville, 41009, Spain

Location

Nektar Investigative Site

Zaragoza, 50009, Spain

Location

MeSH Terms

Interventions

rhoA GTP-Binding Protein

Intervention Hierarchy (Ancestors)

rho GTP-Binding Proteins; Monomeric GTP-Binding Proteins; GTP-Binding Proteins; GTP Phosphohydrolases; Acid Anhydride Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Intracellular Signaling Peptides and Proteins

Study Officials

• Study Director

  Nektar Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be randomized initially to 1 of 4 groups (A dose regimen, B dose regimen, C dose regimen, or D dose regimen \[placebo\]) for the blinded induction period. At Week 16, the start of the blinded maintenance period, patients who responded well to treatment will be re-randomized within their previously assigned groups to either maintenance regimen 1 or maintenance regimen 2. At Week 16, patients without an adequate response during the blinded induction period may be assigned to receive open label escape therapy through the maintenance period of the study (up to Week 52); however, patients receiving escape therapy with inadequate improvement in disease severity will be discontinued from the study therapy at Week 32. Any patients enrolled into the blinded maintenance period with acute exacerbation of atopic dermatitis may be eligible to receive open label escape therapy instead.

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: November 15, 2023
• Primary Completion: May 6, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1); US (28); CR (3); BU (10); CZ (4); DE (12); ES (5); CA (11); PL (26); AU (7)