NCT05129423

A Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot and Dose-Ranging Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This pilot and dose-ranging study will evaluate the efficacy, safety, and pharmacokinetics of MTPS9579A compared with placebo in participants with chronic spontaneous urticaria (CSU) refractory to antihistamines. This study comprises two parts. In Part 1, participants will be randomized to receive MTPS9579A or placebo. On the basis of positive results from Part 1, a dose-ranging Part 2 may be opened, where participants will be randomized to receive one of four MTPS9579A doses or placebo.

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
DRUG	MTPS9579A	MTPS9579A will be administered.
DRUG	Placebo	Placebo matched with MTPS9579A will be administered.

Timeline

• Start date: 2022-07-31
• Primary completion: 2024-07-31
• Completion: 2024-08-31
• First posted: 2021-11-22
• Last updated: 2022-11-18

Regulatory

• FDA-regulated drug study