Trial intelligence / Profile preview

Benralizumab in Chronic Prurigo

NCT05528913Phase 2

Key facts

Status: Withdrawn
Start: Oct 2023
Primary completion: Oct 2023
Countries: 1
Sponsor: Charité – Universitätsmedizin Berlin
Modality: Monoclonal Antibodies

Drugs: benralizumab
Conditions: chronic prurigo (CPG)

Overview

Phase 2, randomised, double-blind trial in chronic prurigo (CPG) comparing Benralizumab with Placebo (2 arms). Primary endpoint: Worst Itch Numerical Rating Scale at 12 weeks. Planned start Oct 2023; status: withdrawn.

Design

2 arms

Study design: RandomizedDouble-blind

Benralizumab
Fasenra 60mg s.c. administration
Placebo
Placebo s.c. administration

Who it enrols

Adult patients with a clinical diagnosis of Chronic Prurigo for at least 6 months, severe pruritus (WI-NRS >= 6), and at least 20 lesions. Patients with active COVID-19, HIV, active liver disease, or recent malignancy are excluded.

Endpoints

Primary

Worst Itch Numerical Rating Scale12 weeks

Secondary

Responder rates12 weeks
Prurigo Activity Score12 weeks
Prurigo Control Test12 weeks
Investigator Global Assessment12 weeks
Investigator Global Assessment-stage12 weeks
Quality of Life12 weeks
Numerical Rating Scale of Sleep Disturbance12 weeks

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