NCT07690371 A Phase 3 Study of Rezpegaldesleukin (NKTR-358) for Patients ≥ 12 Years of Age With Moderate-to-Severe Atopic Dermatitis
| NCT ID | NCT07690371 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Nektar Therapeutics |
| Condition | Moderate-to-Severe Atopic Dermatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 510 participants |
| Start Date | 2026-07 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 510 participants in total. It began in 2026-07 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Male or female patients, ≥ 12 years of age on the day of signing the informed consent form and weighing ≥ 40 kg prior to randomization at Baseline * 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 * Patients must meet the following AD severity criteria: * IGA score ≥ 3 (scale of 0 to 4) at Screening and Baseline * ≥ 10.0% of BSA involvement at Screening and Baseline * EASI ≥ 16.0 at Screening and Baseline * Are candidates for systemic therapy and have history, documented by a physician and/or the Investigator, of inadequate response to existing topical medications within 6 months preceding Screening, or history of intolerance to a topical therapy * Provide written, informed consent to participate in the study and follow the study procedures, including compliance with the use of highly effective contraceptives Exclusion Criteria: * Are currently experiencing or have a history of concomitant skin conditions other than AD, including skin infection in the area affected by the patient's AD that requires treatment with systemic antimicrobial therapy * Are currently experiencing or have a history of unstable course of AD * History of chronic idiopathic urticaria at any time or urticaria from other causes within 4 weeks prior to randomization at the Baseline Visit. * Have a history of TCS use suggestive of a high risk for topical corticosteroid (TCS) withdrawal * Have received any of the following treatments at any time before Screening: aldesleukin; investigational IL-2 analog; systemic biologic; oral JAKi; or any prior investigational agent for AD * Have a current or recent acute, active infection
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07690371 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Moderate-to-Severe Atopic Dermatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07690371 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 510 participants.
Is NCT07690371 currently recruiting?
Yes, NCT07690371 is actively recruiting participants. Contact the research team at StudyInquiry@nektar.com for enrollment information.
Where is the NCT07690371 trial being conducted?
This trial is being conducted at St. Petersburg, United States.
Who is sponsoring the NCT07690371 clinical trial?
NCT07690371 is sponsored by Nektar Therapeutics. The trial plans to enroll 510 participants.
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