A Phase 2 interventional study of Rezpegaldesleukin and Placebo in Moderate to Severe Atopic Dermatitis, sponsored by Nektar Therapeutics. Active, not recruiting at 107 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Nektar Therapeutics · Phase 2, Interventional, and Treatment
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.
AD disease severity at screening and randomization:
Exclusion Criteria:
Rezpegaldesleukin Dose Regimen A every 2 weeks during the induction period
Drug: Rezpegaldesleukin
Rezpegaldesleukin Dose Regimen A every 4 weeks during the maintenance period
Drug: Rezpegaldesleukin
Rezpegaldesleukin Dose Regimen A every 12 weeks during the maintenance period
Drug: Rezpegaldesleukin · Drug: Placebo
Rezpegaldesleukin Dose Regimen B every 4 weeks during the induction period
Drug: Rezpegaldesleukin · Drug: Placebo
Rezpegaldesleukin Dose Regimen B every 4 weeks during the maintenance period
Drug: Rezpegaldesleukin
Rezpegaldesleukin Dose Regimen B every 12 weeks during the maintenance period
Drug: Rezpegaldesleukin · Drug: Placebo
Rezpegaldesleukin Dose Regimen C every 2 weeks during the induction period
Drug: Rezpegaldesleukin
Rezpegaldesleukin Dose Regimen C every 4 weeks during the maintenance period
Drug: Rezpegaldesleukin
Rezpegaldesleukin Dose Regimen C every 12 weeks during the maintenance period
Drug: Rezpegaldesleukin · Drug: Placebo
Placebo every 2 weeks during the induction period
Drug: Placebo
Placebo every 4 weeks during the maintenance period
Drug: Placebo
Rezpegaldesleukin Dose Regimen A every 2 weeks during the maintenance period
Drug: Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Also known as: NKTR-358, REZPEG, LY3471851 (formerly)
Pharmaceutical form: Injection solution Route of administration: subcutaneous
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.
Time frame: Week 0 and Week 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
The vIGA-AD scale ranges from 0 to 4, with higher score indicating more severe atopic dermatitis.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: From Week 0 through Week 104
Rezpegaldesleukin plasma concentration assessed throughout the study
Time frame: Through end of study (week 104)
Incidence of Serious Adverse Events (SAEs)
Time frame: Through end of study (week 104)
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Through end of study (week 104)
Showing the first 100 of 107 sites across 10 countries.
Plan to share: No
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Nektar Therapeutics