NCT05335499

A Phase 2a Study of TAS5315 in Patients With Chronic Spontaneous Urticaria

A Phase 2a, Randomized, Double-blind, Study of TAS5315 in Chronic Spontaneous Urticaria Patients With an Inadequate Response to H1-antihistamines

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Taiho Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of TAS5315 in chronic spontaneous urticaria patients with an inadequate response to H1-antihistamines

Detailed description

The main purpose of this study is to assess the efficacy of TAS5315 in chronic spontaneous urticaria patients with an inadequate response to H1-antihistamines compared with placebo as measured by the change from baseline in weekly Urticaria Activity Score (UAS7) at week 12

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
DRUG	TAS5315 Dose 1	Treatment period: oral administration for 12 weeks, QD
DRUG	TAS5315 Dose 2	Treatment period: oral administration for 12 weeks, QD
DRUG	TAS5315 Dose 3	Treatment period: oral administration for 12 weeks, QD
DRUG	TAS5315 Dose 4	Treatment period: oral administration for 12 weeks, QD
DRUG	TAS5315 Dose 5	Treatment period: oral administration for 12 weeks, QD
DRUG	Placebo	* Screening period: oral administration for 2 weeks, QD * Treatment period: oral administration for 12 weeks, QD

Timeline

• Start date: 2022-06-28
• Primary completion: 2023-12-22
• Completion: 2023-12-22
• First posted: 2022-04-19
• Last updated: 2024-08-07

Locations

12 sites across 1 country: Japan