A phase 2B, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of Rezpegaldesleukin in the treatment of severe to very severe alopecia areata in adult patients (Rezolve AA)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509981-39-00

Acronym

23-358-06

Enrollment

Registered

2024-11-18

Start date

2024-11-20

Completion date

Unknown

Last updated

2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia Areata

Brief summary

Percent change from baseline in Severity of Alopecia Tool (SALT) score at Week 36

Detailed description

Percent change from baseline in SALT score at Weeks 12, 16, 20, 24, 28 and 32, Proportion of patients achieving improvement in SALT (≥50%, ≥75%, and ≥90%) relative to their baseline score (SALT50, SALT75 and SALT90) at Weeks 12, 16, 20, 24, 28, 32, and 36, Proportion of patients achieving an absolute SALT score ≤10, ≤20, ≤30, ≤50 relative to their baseline score at Weeks 12, 16, 20, 24, 28, 32, and 36

Interventions

DRUGNKTR-358

DRUGPlacebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change from baseline in Severity of Alopecia Tool (SALT) score at Week 36	—

Secondary

Measure	Time frame
Percent change from baseline in SALT score at Weeks 12, 16, 20, 24, 28 and 32, Proportion of patients achieving improvement in SALT (≥50%, ≥75%, and ≥90%) relative to their baseline score (SALT50, SALT75 and SALT90) at Weeks 12, 16, 20, 24, 28, 32, and 36, Proportion of patients achieving an absolute SALT score ≤10, ≤20, ≤30, ≤50 relative to their baseline score at Weeks 12, 16, 20, 24, 28, 32, and 36	—

Measure

Time frame

—

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026