A Phase 3 interventional study of Rezpegaldesleukin and Placebo in Moderate-to-Severe Atopic Dermatitis, sponsored by Nektar Therapeutics. Recruiting at 13 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Nektar Therapeutics · Phase 3, Interventional, and Treatment
This is an interventional, randomized, parallel group, treatment, Phase 3, double blind study to assess the effect of Rezpegaldesleukin in participants 12 years of age or older with moderate to severe atopic dermatitis, as compared to placebo.
The estimated participant overall duration is approximately 15 months.
Chronic atopic dermatitis (AD) defined as onset of AD signs and symptoms
≥ 12 months prior to Screening as determined by the Investigator through patient interview and/or review of medical history at the Screening Visit
Exclusion Criteria:
Rezpegaldesleukin every 2 weeks during the induction period
Drug: Rezpegaldesleukin
Placebo every 2 weeks during the induction period
Drug: Placebo
Rezpegaldesleukin every 4 weeks during the maintenance period
Drug: Rezpegaldesleukin
Rezpegaldesleukin every 12 weeks during the maintenance period
Drug: Rezpegaldesleukin
Placebo every 4 weeks during the maintenance period
Drug: Placebo
Rezpegaldesleukin at a frequency determined by the investigator during the open-label escape
Drug: Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Also known as: NKTR-358
Pharmaceutical form: Injection solution Route of administration: subcutaneous
US only: Number of participants with an Investigator's Global Assessment (IGA) score of 0 or 1 and reduction ≥ 2 points from baseline at Week 24
The IGA scale ranges from 0 to 4, with higher score indicating more severe disease.
Time frame: Week 0 and Week 24
Non-US regions only: Number of participants with an Investigator's Global Assessment (IGA) score of 0 or 1 at Week 24
The IGA scale ranges from 0 to 4, with higher score indicating more severe disease.
Time frame: Week 0 and Week 24
Non-US regions only: Number of participants with a ≥ 75% reduction in Eczema Area and Severity Index (EASI) score from baseline at Week 24 (EASI-75)
The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.
Time frame: Week 0 and Week 24
US only: Number of participants with a ≥ 75% reduction in EASI score from baseline at Week 24 (EASI-75)
The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.
Time frame: Week 0 and Week 24
Number of participants with a ≥ 90% reduction in EASI score from baseline at Week 24 (EASI-90)
The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.
Time frame: Week 0 and Week 24
Number of participants at week 6 achieving a 4-point or greater improvement in Itch numerical rating scale (NRS) in the subset of participants 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 6
Number of participants at week 24 achieving a 4-point or greater improvement in Itch numerical rating scale (NRS) in the subset of participants 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 24
Number of participants at week 6 achieving a 4-point or greater improvement in Skin Pain numerical rating scale (NRS) in the subset of participants with a 4-point or greater Skin Pain NRS at baseline
The Skin Pain NRS goes from 0 to 10, with higher score indicating more severe pain.
Time frame: Week 0 and Week 6
Number of participants at week 24 achieving a 4-point or greater improvement in Skin Pain numerical rating scale (NRS) in the subset of participants with a 4-point or greater Skin Pain NRS at baseline
The Skin Pain NRS goes from 0 to 10, with higher score indicating more severe pain.
Time frame: Week 0 and Week 24
Number of participants at week 6 achieving a 1.25-point or greater improvement in Atopic Dermatitis Sleep Scale Question 1 (ADSS Q1) in the subset of participants with a 1.25-point or greater ADSS Q1 at baseline
The ADSS Q1 goes from 0 to 4, with higher score indicating more difficulty sleeping.
Time frame: Week 0 and Week 6
Number of participants at week 24 achieving a 1.25-point or greater improvement in ADSS Q1 in the subset of participants with a 1.25-point or greater ADSS Q1 at baseline
The ADSS Q1 goes from 0 to 4, with higher score indicating more difficulty sleeping.
Time frame: Week 0 and Week 24
Change in Asthma Control Questionnaire-5 (ACQ-5) score from baseline at Week 24 in the subpopulation of patients with a 0.5-point or greater ACQ-5 at baseline
The ACQ-5 goes from 0 to 6, with higher score indicating worse asthma control.
Time frame: Week 0 and Week 24
Number of participants at week 24 achieving a 0.5-point or greater improvement in ACQ-5 in the subset of participants with a 0.5-point or greater ACQ-5 at baseline
The ACQ-5 goes from 0 to 6, with higher score indicating worse asthma control.
Time frame: Week 0 and Week 24
Change in Sino-Nasal Outcome Test (SNOT-22) score from baseline at Week 24 in the subpopulation of patients with an 8.9-point or greater SNOT-22 at baseline
The SNOT-22 scores range from 0 to 110, with a higher score indicating more severe symptoms
Time frame: Week 0 and Week 24
Number of participants at Week 24 achieving a 8.9-point or greater reduction from baseline in SNOT-22 in the subpopulation of patients with an 8.9-point or greater SNOT-22 at baseline
The SNOT-22 scores range from 0 to 110, with a higher score indicating more severe symptoms
Time frame: Week 0 and Week 24
Number of participants at week 24 achieving an Adapted Investigator's Global Assessment (aIGA) response of 0 or 1
The aIGA scale ranges from 0 to 1, with a lower score indicating improvement in atopic dermatitis.
Time frame: Week 0 and Week 24
Number of participants with treatment emergent adverse events (TEAEs)
Time frame: Through participant study completion, approximately Week 56
Number of participants with treatment emergent serious adverse events
Time frame: Through participant study completion, approximately Week 56
Number of participants with treatment related serious adverse events
Time frame: Through participant study completion, approximately Week 56
Number of participants with treatment emergent adverse events of special interest
Time frame: Through participant study completion, approximately Week 56
Number of participants with treatment related adverse events of special interest
Time frame: Through participant study completion, approximately Week 56
Number of participants with TEAEs leading to treatment discontinuation
Time frame: Through participant study completion, approximately Week 56
Number of participants with TEAEs leading to dose hold
Time frame: Through participant study completion, approximately Week 56
Number of participants with TEAEs leading to dose modifications
Time frame: Through participant study completion, approximately Week 56
Plan to share: No
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Nektar Therapeutics