A Phase 3 interventional study of Rezpegaldesleukin and Placebo in Moderate-to-Severe Atopic Dermatitis, sponsored by Nektar Therapeutics. Recruiting at 20 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
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.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 510 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Nektar Therapeutics is the lead sponsor of 39 studies on the registry; 2 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 13 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Rezpegaldesleukin