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

NCT05335499 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2024-08-07

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Taiho Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Taiho Pharmaceutical Co., Ltd. · Taiho Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-28
Primary Completion
2023-12-22
Completion
2023-12-22

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05335499 on ClinicalTrials.gov