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

Phase 3RecruitingNCT07711418

Nektar Therapeutics510 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

510

Conditions

Moderate-to-Severe Atopic Dermatitis

Interventions

RezpegaldesleukinDRUG

Pharmaceutical form: Injection solution Route of administration: subcutaneous

PlaceboDRUG

Pharmaceutical form: Injection solution Route of administration: subcutaneous

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (13)

Nektar Investigative Site

Birmingham, Alabama, United States

RECRUITING

Nektar Investigative Site

Oxnard, California, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Nektar Recruitment

CONTACT

855-482-8676 StudyInquiry@nektar.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

Nektar Investigative Site

Metairie, Louisiana, United States

RECRUITING

Nektar Investigative Site

Kirksville, Missouri, United States

RECRUITING

Nektar Investigative Site

Lee's Summit, Missouri, United States

RECRUITING

Nektar Investigative Site

Las Vegas, Nevada, United States

RECRUITING

...and 3 more locations

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