Back to search results

Phase 3 Study of Rezpegaldesleukin for Moderate-to-Severe Atopic Dermatitis

This Phase 3 study is testing an investigational medicine called Rezpegaldesleukin for people aged 12 and older who have moderate-to-severe atopic dermatitis (eczema). You would receive either Rezpegaldesleukin or a placebo (an inactive substance) through an injection under the skin. Researchers want to see if Rezpegaldesleukin can improve your eczema symptoms, specifically looking at how clear your skin becomes and how much your Eczema Area and Severity Index (EASI) score improves by Week 24. The study aims to enroll 510 participants, but the current recruitment status is unclear.

Study design
This is a Phase 3, randomized, double-blind study comparing Rezpegaldesleukin to a placebo in approximately 510 participants.
What's involved
Your participation in this study is expected to last about 15 months. You will have assessments at Week 0 and Week 24 to measure your eczema symptoms.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at Week 24, but the overall study duration is approximately 15 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07711418

A Phase 3 Study of Rezpegaldesleukin (NKTR-358) for Patients ≥ 12 Years of Age With Moderate-to-Severe Atopic Dermatitis

Recruiting
PHASE3Ages 12+InterventionalTreatment
Nektar Therapeutics
~510 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:RezpegaldesleukinPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over Week 0 and Week 24
+2 more outcomes measured

Conditions

Moderate-to-Severe Atopic Dermatitis

Explore related trials

Atopic Dermatitis

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Study Director · STUDY_DIRECTOR · Nektar Therapeutics

Who to contact

Nektar Recruitment
[email protected]
855-482-8676
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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
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

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

What this trial measures

  • 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 24Week 0 and Week 24

    The IGA scale ranges from 0 to 4, with higher score indicating more severe disease.

  • Non-US regions only: Number of participants with an Investigator's Global Assessment (IGA) score of 0 or 1 at Week 24Week 0 and Week 24

    The IGA scale ranges from 0 to 4, with higher score indicating more severe disease.

  • 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)Week 0 and Week 24

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