A Phase 3 test of Rezpegaldesleukin (NKTR-358) for moderate-to-severe atopic dermatitis in patients 12 years and older

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, parallel-group trial evaluating the effect of Rezpegaldesleukin versus placebo in participants 12 years and older with moderate-to-severe atopic dermatitis. Eligible participants must have a history of chronic AD, meet specific severity criteria, and have inadequate response or intolerance to topical therapies. The study uses a systemic treatment approach and plans for about 15 months of participant involvement. The lead sponsor is Nektar Therapeutics, with three investigative sites in California and Alabama.

Why it matters

Who can join: the full rules

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

Where it's running

• Nektar Investigative Site
  Birmingham, Alabama, United States Recruiting
• Nektar Investigative Site
  Oxnard, California, United States Recruiting
• Nektar Investigative Site
  Palmdale, California, United States Recruiting
• Nektar Investigative Site
  Sacramento, California, United States Recruiting
• Nektar Investigative Site
  Tamarac, Florida, United States Recruiting
• Nektar Investigative Site
  Savannah, Georgia, United States Recruiting

Study contacts

• Study coordinator: Nektar Recruitment
• Email: StudyInquiry@nektar.com
• Phone: 855-482-8676

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Rezpegaldesleukin for moderate-to-severe atopic dermatitis in people 12 and older

  This study tests whether Rezpegaldesleukin helps people aged 12 and up with moderate-to-severe atopic dermatitis compared with a placebo.

  Recruiting at 20 sites Phase 3 Nektar Therapeutics · Phoenix, Arizona and 19 other locations · NCT07690371

• Nemolizumab for infants with moderate-to-severe atopic dermatitis

  This study tests whether nemolizumab can be safely given to infants aged 6 to under 24 months to help manage moderate-to-severe eczema when topical treatments alone aren’t enough.

  Recruiting Phase 2 Galderma R&D · San Antonio, Texas · NCT07660835

• SYX-5219 in healthy adults and adults with moderate-to-severe atopic dermatitis

  This trial will test oral SYX-5219 in healthy adults and in adults with moderate-to-severe atopic dermatitis to see if it is safe, well tolerated, and how the drug is processed in the body.

  Recruiting at 12 sites Phase 1 Sitryx Therapeutics Ltd · Arkansas City, Arkansas and 13 other locations · NCT07558668

• Oral LW402 for moderate-to-severe atopic dermatitis

  This phase 3 study tests whether oral LW402 tablets can help adults with moderate-to-severe atopic dermatitis compared with a placebo.

  Recruiting Phase 3 Shanghai Longwood Biopharmaceuticals Co., Ltd. · Beijing · NCT07370909

• SHR-1905 treatment for moderate-to-severe atopic dermatitis

  This trial will test whether SHR-1905 injections help adults aged 18–75 who have moderate-to-severe atopic dermatitis.

  Recruiting Phase 2 Guangdong Hengrui Pharmaceutical Co., Ltd · Guangzhou, Guangdong · NCT07211542

• TRB-061 injections for healthy adults and people with moderate-to-severe atopic dermatitis

  This trial will test subcutaneous TRB-061 injections in healthy adults and adults with moderate-to-severe atopic dermatitis to check safety, dosing, and how the drug acts in the body.

  Recruiting at 18 sites Phase 1 TRex Bio, Inc. · Deakin, Australian Capital Territory and 18 other locations · NCT06934252

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.