NCT06136741

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

A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis (REZOLVE-AD)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 396 (estimated)
• Sponsor: Nektar Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 4-arm study to assess the effect of pegylated-recombinant-human interleukin-2 (rezpegaldesleukin) in adult participants with moderate to severe atopic dermatitis. The estimated duration is 15-35 days for screening, an Induction Period of 16 weeks, a Maintenance Period from Week 16-Week 52, and a Posttreatment Follow-Up Period for an additional year up to approximately Week 104 for all patients. Patients with a response at Week 16 (end of induction therapy) will be re-randomized for the maintenance therapy period.

Conditions

• Moderate to Severe Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Rezpegaldesleukin	Pharmaceutical form: Injection solution Route of administration: subcutaneous
DRUG	Placebo	Pharmaceutical form: Injection solution Route of administration: subcutaneous

Timeline

• Start date: 2023-11-15
• Primary completion: 2025-05-06
• Completion: 2026-12-31
• First posted: 2023-11-18
• Last updated: 2026-03-31

Locations

107 sites across 10 countries: United States, Australia, Bulgaria, Canada, Croatia, Czechia, Germany, Hungary, Poland, Spain

Regulatory

• FDA-regulated drug study