Active — Not RecruitingPhase 3

Study on the Treatment of Prurigo Nodularis With Stapokibart Injection

China200 participantsStarted 2024-06-25

Plain-language summary

This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of Stapokibart Injection in the treatment of subjects with prurigo nodularis, and observe pharmacokinetic characteristics, pharmacological effects, and immunogenicity.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Able to understand and agree to comply with the experimental process of this study and voluntarily sign the informed consent form. * 18 ≤ Age ≤ 75 years old. * Received at least 2 weeks of moderate or more potent topical corticosteroid therapy with insufficient efficacy. Exclusion Criteria: * With drug-induced prurigo nodularis. * With clinically significant diseases. * With severe liver and kidney function damage at the screening. * With malignant tumors within the first 5 years before the screening. * Plan to undergo major surgical procedures during this study.

What they're measuring

Proportion of subjects improved by ≥ 4 points from baseline on the Worst Itch Numerical Rating Scale (WI-NRS) at week 24 of treatment.

Timeframe: Up to week 24

Trial details

NCT IDNCT06424470

SponsorKeymed Biosciences Co.Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-30

View on ClinicalTrials.gov More Prurigo Nodularis trials