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

Conditions

• Moderate-to-Severe Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Rezpegaldesleukin — DRUG
  Pharmaceutical form: Injection solution Route of administration: subcutaneous
• Placebo — DRUG
  Pharmaceutical form: Injection solution Route of administration: subcutaneous

Study Details

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.

Key Dates

First listed

Jul 8, 2026

Start date

Jul 31, 2026

Status verified

Jul 2026

Primary completion

May 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

510 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Blinded Induction Period: Rezpegaldesleukin every 2 weeks
  Rezpegaldesleukin every 2 weeks during the induction period
• Placebo Comparator: Blinded Induction Period: Placebo
  Placebo every 2 weeks during the induction period
• Experimental: Blinded Maintenance Period: Rezpegaldesleukin every 4 weeks
  Rezpegaldesleukin every 4 weeks during the maintenance period
• Experimental: Blinded Maintenance Period: Rezpegaldesleukin every 12 weeks
  Rezpegaldesleukin every 12 weeks during the maintenance period
• Placebo Comparator: Blinded Maintenance Period: Placebo
  Placebo every 4 weeks during the maintenance period
• Experimental: Open-Label Escape
  Rezpegaldesleukin at a frequency determined by the investigator during the open-label escape

Primary Outcome Measure

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 [ Time Frame: Week 0 and Week 24 ]

Central Contacts

• Nektar Recruitment
  855-482-8676
  [email protected]

Locations (1)

Find similar trials in St. Petersburg, FL