510 Participants NeededMy employer runs this trial

Rezpegaldesleukin for Eczema

(ZENITH AD-2 Trial)

Recruiting at 12 trial locations
NR
Overseen ByNektar Recruitment
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called Rezpegaldesleukin for individuals with moderate to severe eczema (also known as atopic dermatitis). The study will compare Rezpegaldesleukin to a placebo (a dummy treatment) to evaluate its effectiveness over approximately 15 months. Participants will receive the treatment at varying intervals to determine the most effective schedule. Individuals who have experienced eczema for over a year, with frequent flare-ups and difficulty finding relief with creams, might be suitable candidates for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to the potential availability of a new treatment.

Is there any evidence suggesting that Rezpegaldesleukin is likely to be safe for humans?

Research has shown that rezpegaldesleukin is generally safe for people with moderate to severe eczema. One study found serious side effects were rare, occurring in only about 2% of participants, with no deaths reported during the first 16 weeks. Over a longer 36-week period, participants tolerated the treatment well, and no new safety issues emerged. Additionally, a review of nine different studies demonstrated that rezpegaldesleukin was safe and well-tolerated, even among healthy individuals and those with long-term inflammatory conditions. Overall, these findings suggest that rezpegaldesleukin is a promising option for managing eczema with a good safety record.12345

Why do researchers think this study treatment might be promising for eczema?

Rezpegaldesleukin is unique because it targets eczema differently than standard treatments like topical corticosteroids and calcineurin inhibitors. It works by modulating the immune system with a specific focus on reducing inflammation through the activation of regulatory T cells. Researchers are excited about its potential for longer-lasting effects, as the treatment is administered every 2 to 12 weeks, which could mean fewer applications compared to daily treatments. This innovative approach might offer more sustained relief with less frequent dosing, making it an attractive option for those seeking alternatives to current therapies.

What evidence suggests that Rezpegaldesleukin might be an effective treatment for eczema?

Research has shown that Rezpegaldesleukin may help treat moderate to severe atopic dermatitis, also known as eczema. In earlier studies, patients who took Rezpegaldesleukin experienced significantly better skin improvements than those who took a placebo, a harmless pill with no active medicine. These improvements included a decrease in the severity and spread of eczema symptoms. Rezpegaldesleukin works by adjusting the immune system, which is believed to reduce the inflammation that causes eczema. Early results suggest it can lead to clearer skin and relief from itching, major concerns for people with eczema. Overall, the evidence supports the potential of Rezpegaldesleukin in managing eczema symptoms.

Who Is on the Research Team?

SD

Study Director

Principal Investigator

Nektar Therapeutics

Are You a Good Fit for This Trial?

This trial is for people aged 12 and older who have moderate to severe atopic dermatitis (eczema). Participants should be generally healthy aside from their eczema. Those with certain other medical conditions or recent use of specific treatments may not be eligible.

Inclusion Criteria

Provide written, informed consent to participate in the study and follow the study procedures, including compliance with the use of highly effective contraceptives
I am at least 12 years old and weigh at least 40 kg.
I have had atopic dermatitis symptoms for at least 12 months.
See 4 more

Exclusion Criteria

Have a history of TCS use suggestive of a high risk for topical corticosteroid (TCS) withdrawal
I have had chronic hives or recent hives from any cause.
I have a current or recent active infection.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Blinded Induction Period

Participants receive Rezpegaldesleukin or placebo every 2 weeks during the induction period

12 weeks
6 visits (in-person)

Blinded Maintenance Period

Participants receive Rezpegaldesleukin or placebo every 4 to 12 weeks during the maintenance period

12 weeks
3-6 visits (in-person)

Open-Label Escape

Participants may receive Rezpegaldesleukin at a frequency determined by the investigator

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Rezpegaldesleukin

Trial Overview

The study compares Rezpegaldesleukin, a new medication, to a placebo in treating moderate-to-severe eczema. Participants are randomly assigned to one of the two groups and neither they nor the researchers know which treatment they're getting.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Placebo Group

Group I: Open-Label EscapeExperimental Treatment1 Intervention
Group II: Blinded Maintenance Period: Rezpegaldesleukin every 4 weeksExperimental Treatment1 Intervention
Group III: Blinded Maintenance Period: Rezpegaldesleukin every 12 weeksExperimental Treatment1 Intervention
Group IV: Blinded Induction Period: Rezpegaldesleukin every 2 weeksExperimental Treatment1 Intervention
Group V: Blinded Induction Period: PlaceboPlacebo Group1 Intervention
Group VI: Blinded Maintenance Period: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nektar Therapeutics

Lead Sponsor

Trials
59
Recruited
9,900+

Howard W. Robin

Nektar Therapeutics

Chief Executive Officer since 2007

B.S. in Accounting and Finance from Fairleigh Dickinson University

Dr. Dimitry Nuyten

Nektar Therapeutics

Chief Medical Officer since 2022

MD

Citations

Nektar Announces Publication in The Lancet of Positive ...

Safety data for rezpegaldesleukin. Serious adverse events were rare (2%), with no deaths reported during the 16-week induction period and no ...

two randomized, double-blind, placebo-controlled phase 1b ...

Here, in two phase lb trials, the authors show that rezpegaldesleukin, a Treg-selective pegylated IL-2, is safe and improves symptoms in patients with atopic ...

NCT06136741 | A Phase 2b Study to Evaluate ...

a data safety and monitoring board, Rezpegaldesleukin. The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.

REZOLVE-AD Trial Results Show Promise for ...

Rezpegaldesleukin showed significant efficacy in improving EASI scores and itch relief in atopic dermatitis patients, meeting primary and ...

New REZOLVE-AD Maintenance Data in Atopic Dermatitis ...

Rezpegaldesleukin was well-tolerated with no new safety concerns identified during the 36-week maintenance and escape periods. The ...