NCT04827589

Study to Evaluate the Efficacy, Safety, and Tolerability of Tirabrutinib in Participants With Antihistamine-Resistant Chronic Spontaneous Urticaria

A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of Tirabrutinib in Subjects With Antihistamine-Resistant Chronic Spontaneous Urticaria

• Status: Withdrawn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

Summary

The primary objective of this study is to evaluate the efficacy of tirabrutinib in reducing disease activity in participants with chronic spontaneous urticaria (CSU) with respect to change from baseline in urticaria activity score over 7 days (UAS7) at Week 8 when added to standard of care.

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
DRUG	Tirabrutinib	Tablets administered orally
DRUG	Placebo	Tablets administered orally

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-04-01
• Completion: 2022-09-01
• First posted: 2021-04-01
• Last updated: 2021-07-28

Regulatory

• FDA-regulated drug study