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).

Conditions

Atopic Dermatitis

Brief summary

Mean percent change in EASI from baseline at Week 16

Detailed description

Proportion of patients from baseline at Week 16 achieving • vIGA AD of 0 or 1 and at least a 2-point reduction. • EASI-75 • EASI 90 • EASI-50 • ≥ 4-point improvement from baseline in Itch NRS in the subset of patients with ≥ 4-point Itch NRS at baseline. • SCORAD-75 • SCORAD-50, Mean change from baseline over the period between Week 0 and Week 104 in • EASI • SCORAD • BSA involvement, Mean percent change from baseline over the period between Week 0 and Week 104 in • EASI • SCORAD • BSA involvement, In addition, all of the above efficacy assessments will be further evaluated at other time points during induction therapy, maintenance therapy, and follow-up - Rezpegaldesleukin plasma concentrations at various time points assessed throughout the study. - Incidence of • Serious adverse events (SAEs) • Treatment-emergent adverse events (TEAEs)

Related papers

No related papers found yet.

Interventions

DRUGNKTR-358

DRUGSodium Chloride 0.9% solution

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Mean percent change in EASI from baseline at Week 16	—

Secondary

Measure	Time frame
Proportion of patients from baseline at Week 16 achieving • vIGA AD of 0 or 1 and at least a 2-point reduction. • EASI-75 • EASI 90 • EASI-50 • ≥ 4-point improvement from baseline in Itch NRS in the subset of patients with ≥ 4-point Itch NRS at baseline. • SCORAD-75 • SCORAD-50, Mean change from baseline over the period between Week 0 and Week 104 in • EASI • SCORAD • BSA involvement, Mean percent change from baseline over the period between Week 0 and Week 104 in • EASI • SCORAD • BSA involvement, In addition, all of the above efficacy assessments will be further evaluated at other time points during induction therapy, maintenance therapy, and follow-up - Rezpegaldesleukin plasma concentrations at various time points assessed throughout the study. - Incidence of • Serious adverse events (SAEs) • Treatment-emergent adverse events (TEAEs)	—

Measure

Time frame

Proportion of patients from baseline at Week 16 achieving • vIGA AD of 0 or 1 and at least a 2-point reduction. • EASI-75 • EASI 90 • EASI-50 • ≥ 4-point improvement from baseline in Itch NRS in the subset of patients with ≥ 4-point Itch NRS at baseline. • SCORAD-75 • SCORAD-50, Mean change from baseline over the period between Week 0 and Week 104 in • EASI • SCORAD • BSA involvement, Mean percent change from baseline over the period between Week 0 and Week 104 in • EASI • SCORAD • BSA involvement, In addition, all of the above efficacy assessments will be further evaluated at other time points during induction therapy, maintenance therapy, and follow-up - Rezpegaldesleukin plasma concentrations at various time points assessed throughout the study. - Incidence of • Serious adverse events (SAEs) • Treatment-emergent adverse events (TEAEs)

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Countries

Bulgaria, Croatia, Czechia, Germany, Hungary, Poland, Spain

Outcome results

None listed