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Interleukin

Rezpegaldesleukin for Atopic Dermatitis (REZOLVE-AD Trial)

Phase 2

Recruiting

Research Sponsored by Nektar Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

AD disease severity at screening and randomization: EASI of 16 or higher, IGA of 3 or 4, BSA of 10% or more

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from week 0 through week 54

Awards & highlights

REZOLVE-AD Trial Summary

This trial is testing a new drug to treat moderate to severe atopic dermatitis in adults, lasting up to 378 days.

Who is the study for?

Adults aged 18-70 with moderate-to-severe atopic dermatitis (AD) for over a year, who haven't responded well to topical treatments. Participants must have an EASI score of 16+, IGA of 3 or 4, and BSA involvement of 10%+. Exclusions include other skin conditions, certain infections like HIV/Hepatitis, cancer history within the last five years (with exceptions), pregnancy/breastfeeding women, recent live vaccines, immune suppression issues, prior AD biologic treatments or severe illnesses.Check my eligibility

What is being tested?

The trial is testing Rezpegaldesleukin (Rezpeg), a pegylated form of interleukin-2 for treating AD. It's randomized and double-blind with four parallel groups: some get Rezpeg while others receive a placebo. The study includes initial treatment up to day 280 followed by safety follow-up until approximately day 378.See study design

What are the potential side effects?

Potential side effects are not specified here but may include reactions typical to immunomodulating therapies such as injection site reactions, flu-like symptoms including fever and chills, fatigue, rash or worsening eczema.

REZOLVE-AD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My eczema is severe, covering 10% or more of my body.

REZOLVE-AD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from week 0 through week 54

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from week 0 through week 54

This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 0 through week 54 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean percent change in the Eczema Area and Severity Index (EASI) from baseline at Week 16

Secondary outcome measures

Incidence of Serious Adverse Events (SAEs)

Incidence of Treatment Emergent Adverse Events (TEAEs)

Mean change from baseline over the period between week 0 and week 54 in Eczema Area and Severity Index (EASI)

+13 more

REZOLVE-AD Trial Design

12Treatment groups

Experimental Treatment

Placebo Group

Group I: Escape Therapy (open-label)Experimental Treatment1 Intervention

Rezpegaldesleukin Dose Regimen A every 2 weeks during the maintenance period

Group II: Arm C2Experimental Treatment2 Interventions

Rezpegaldesleukin Dose Regimen C every 12 weeks during the maintenance period

Group III: Arm C1Experimental Treatment1 Intervention

Rezpegaldesleukin Dose Regimen C every 4 weeks during the maintenance period

Group IV: Arm CExperimental Treatment1 Intervention

Rezpegaldesleukin Dose Regimen C every 2 weeks during the induction period

Group V: Arm B2Experimental Treatment2 Interventions

Rezpegaldesleukin Dose Regimen B every 12 weeks during the maintenance period

Group VI: Arm B1Experimental Treatment1 Intervention

Rezpegaldesleukin Dose Regimen B every 4 weeks during the maintenance period

Group VII: Arm BExperimental Treatment2 Interventions

Rezpegaldesleukin Dose Regimen B every 4 weeks during the induction period

Group VIII: Arm A2Experimental Treatment2 Interventions

Rezpegaldesleukin Dose Regimen A every 12 weeks during the maintenance period

Group IX: Arm A1Experimental Treatment1 Intervention

Rezpegaldesleukin Dose Regimen A every 4 weeks during the maintenance period

Group X: Arm AExperimental Treatment1 Intervention

Rezpegaldesleukin Dose Regimen A every 2 weeks during the induction period

Group XI: Arm D1Placebo Group1 Intervention

Placebo every 4 weeks during the maintenance period

Group XII: Arm DPlacebo Group1 Intervention

Placebo every 2 weeks during the induction period

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nektar TherapeuticsLead Sponsor

58 Previous Clinical Trials

9,946 Total Patients Enrolled

Study DirectorStudy DirectorNektar Therapeutics

1,211 Previous Clinical Trials

488,876 Total Patients Enrolled

4 Trials studying Eczema

544 Patients Enrolled for Eczema

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many study participants are involved in this investigation?

"Nektar Therapeutics needs 396 participants that meet the criteria to conduct this trial. The study is being run at Clinical Science Institute in Santa Monica, Georgia and Marietta Dermatology & The Skin cancer Center - Marietta in Marietta, Pennsylvania."

Answered by AI

For whom is this clinical trial appropriate?

"This clinical trial is designed to assess the efficacy of a potential eczema treatment, and will enroll 396 individuals between 18-70 years old."

Answered by AI

Are there any available vacancies in this clinical trial for participants?

"Affirmative. As confirmed by the clinicaltrials.gov website, this medical research was initially published on October 23rd 2023 and has been actively recruiting since then. Specifically, 396 patients need to be sourced from 5 different clinics for the trial to move forward."

Answered by AI

Has Arm A acquired the necessary regulatory approvals from the FDA?

"Our analysis yielded a safety rating of 2 for Arm A, due to the lack of efficacy data available from its Phase 2 trial."

Answered by AI

In how many locations is this research endeavor taking place?

"For this trial, Clinical Science Institute in Santa Monica, Georgia Marietta Dermatology & The Skin cancer Center - Marietta in Marietta, Pennsylvania and DermDox Centers for Dermatology in Camp Hill Washington are among the 8 recruitment sites."

Answered by AI

Are octogenarians eligible for enrollment in this particular research project?

"According to the specified eligibility requirements, patients aged 18-70 are invited to participate in this trial. There is an additional 95 trials for minors and 180 for participants older than 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis

2023. "A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06136741.

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