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NCT Number: NCT06136741

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Moderate to Severe Atopic Dermatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nektar Investigative Site, Darlinghurst, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rezpegaldesleukin

Drug

Pharmaceutical form: Injection solution Route of administration: subcutaneous

Other names: NKTR-358, REZPEG, LY3471851 (formerly)

Placebo

Drug

Pharmaceutical form: Injection solution Route of administration: subcutaneous

Primary outcomes

  1. Mean percent change in the Eczema Area and Severity Index (EASI) from baseline at Week 16

    Time frame: Week 0 and Week 16

    The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.

Secondary outcomes

  1. 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

    Time frame: Week 0 and Week 16

    The vIGA-AD scale ranges from 0 to 4, with higher score indicating more severe atopic dermatitis.

  2. Proportion of patients at week 16 achieving a Eczema Area and Severity Index reduction of 75% relative to their baseline score (EASI-75)

    Time frame: Week 0 and Week 16

    The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.

  3. Proportion of patients at week 16 achieving a Eczema Area and Severity Index reduction of 90% relative to their baseline score (EASI-90)

    Time frame: Week 0 and Week 16

    The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.

  4. Proportion of patients at week 16 achieving a Eczema Area and Severity Index reduction of 50% relative to their baseline score (EASI-50)

    Time frame: Week 0 and Week 16

    The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.

  5. 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

    Time frame: Week 0 and Week 16

    The itch NRS goes from 0 to 10, with higher score indicating more severe itch.

  6. Proportion of patients at week 16 achieving a SCORing Atopic Dermatitis Index (SCORAD) reduction of 75% from their baseline value

    Time frame: Week 0 and Week 16

    The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.

  7. Proportion of patients at week 16 achieving a SCORAD reduction of 50% from their baseline value

    Time frame: Week 0 and Week 16

    The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.

  8. Mean change from baseline over the period between week 0 and week 104 in Eczema Area and Severity Index (EASI)

    Time frame: From Week 0 through Week 104

    The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.

  9. Mean percent change from baseline over the period between week 0 and week 104 in Eczema Area and Severity Index (EASI)

    Time frame: From Week 0 through Week 104

    The EASI scores range from 0 to 72, with higher score indicating more severe atopic dermatitis.

  10. Mean change from baseline over the period between week 0 and week 104 in SCORAD

    Time frame: From Week 0 through Week 104

    The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.

  11. Mean percent change from baseline over the period between week 0 and week 104 in SCORAD

    Time frame: From Week 0 through Week 104

    The SCORAD scores range from 0 to 103, with a higher score indicating more severe atopic dermatitis.

  12. Mean change from baseline over the period between week 0 and week 104 in body surface area (BSA) involvement

    Time frame: From Week 0 through Week 104

  13. Mean percent change from baseline over the period between week 0 and week 104 in body surface area (BSA) involvement

    Time frame: From Week 0 through Week 104

  14. Rezpegaldesleukin plasma concentration assessed throughout the study

    Time frame: Through end of study (week 104)

  15. Incidence of Serious Adverse Events (SAEs)

    Time frame: Through end of study (week 104)

  16. Incidence of Treatment Emergent Adverse Events (TEAEs)

    Time frame: Through end of study (week 104)

Sponsors and collaborators

Lead sponsor

Nektar Therapeutics

Industry

Registry information

Official study 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)

Acronym: REZOLVE-AD

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 18, 2023
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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