NCT04513548

Study of Mechanism of Action of Ligelizumab (QGE031) in Patients With Chronic Urticaria

A Two-part Exploratory Study Combining a Pilot Study in Healthy Subjects and Chronic Spontaneous Urticaria Patients (Part 1) and a Randomized, Subject, Investigator and Sponsor-blinded, Placebo Controlled, Study (Part 2) to Assess the MechAniSm of acTion of ligElizumab (QGE031) in Patients With Chronic uRticaria (MASTER)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to investigate the mechanism of action for ligelizumab (QGE031) treatment in patients with chronic urticaria. The study has two parts. The study population will consist of approximately 68 male and female healthy volunteers and patients. In Part 1, approximately 20 healthy volunteers and patients with chornic urticaria will be enrolled. In Part 2 approximately 48 patients with chronic urticaria (spontaneous chronic urticaria, cholinergic urticaria or cold urticaria). Part 1 consists of a screening period up 2 weeks and a visit with skin tests; there is no treatment taken in Part 1. Part 2 is randomized, subject, investigator and sponsor blinded. It consists of a screening period up to 4 weeks, a 16 week treatment period and a 12-week follow-up period after last treatment. A follow-up call at Week 32 will be performed via telephone.

Detailed description

There are 58 patients out of 68 participants (10 are Healthy Volunteers)

Conditions

• Chronic Spontaneous Urticaria
• Cholinergic Urticaria
• Cold Urticaria

Interventions

Type	Name	Description
DRUG	Ligelizumab	One injection every four weeks
DRUG	Placebo	One injection every four weeks

Timeline

• Start date: 2020-08-05
• Primary completion: 2022-07-19
• Completion: 2022-07-19
• First posted: 2020-08-14
• Last updated: 2024-06-18

Locations

1 site across 1 country: Germany