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

February 7, 2024 updated by: Taiho Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Ehime, Japan
        • Recruiting
        • A site selected by Taiho Pharmaceutical Co., Ltd.
      • Fukuoka, Japan
        • Recruiting
        • A site selected by Taiho Pharmaceutical Co., Ltd.
      • Gunma, Japan
        • Recruiting
        • A site selected by Taiho Pharmaceutical Co., Ltd.
      • Hiroshima, Japan
        • Recruiting
        • A site selected by Taiho Pharmaceutical Co., Ltd.
      • Ishikawa, Japan
        • Recruiting
        • A site selected by Taiho Pharmaceutical Co., Ltd.
      • Kagawa, Japan
        • Recruiting
        • A site selected by Taiho Pharmaceutical Co., Ltd.
      • Kumamoto, Japan
        • Recruiting
        • A site selected by Taiho Pharmaceutical Co., Ltd.
      • Obihiro, Japan
        • Recruiting
        • A site selected by Taiho Pharmaceutical Co., Ltd.
      • Osaka, Japan
        • Recruiting
        • A site selected by Taiho Pharmaceutical Co., Ltd.
      • Sapporo, Japan
        • Recruiting
        • A site selected by Taiho Pharmaceutical Co., Ltd.
      • Tokyo, Japan
        • Recruiting
        • A site selected by Taiho Pharmaceutical Co., Ltd.
      • Yokohama, Japan
        • Recruiting
        • A site selected by Taiho Pharmaceutical Co., Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Aged 18 to 75 years
  • Diagnosis of chronic spontaneous urticaria (CSU)
  • Presence of itch and hives for at least 6 consecutive weeks prior to screening in spite of use of non-sedating H1-antihistamines for CSU
  • UAS7 score ≥ 16 and HSS7 score ≥ 8 during 7 days prior to study entry
  • In-clinic UAS ≥ 4 on study entry
  • Willing and able to complete and Participate Daily for the duration of the study

Key Exclusion Criteria

  • Diseases other than CSU with symptoms of urticaria or angioedema, including urticarial vasculitis, erythema multiforme, mastocytosis, or hereditary or acquired angioedema
  • Atopic dermatitis, psoriasis, ichthyosis, or other skin disease associated with chronic itching
  • Bleeding diathesis
  • Uncontrolled hypertension disease states
  • Treatment with omalizumab or other humanized anti-human IgE monoclonal antibody therapies used to treat CSU within 4 months prior to screening
  • Nonresponse to omalizumab or other humanized anti-human IgE monoclonal antibody therapies
  • Have been treated with other Bruton's Tyrosine Kinase inhibitors
  • Pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
  • Screening period: oral administration for 2 weeks, QD
  • Treatment period: oral administration for 12 weeks, QD
Experimental: TAS5315 Dose 1
Drug: TAS5315 Dose 1
Treatment period: oral administration for 12 weeks, QD
Experimental: TAS5315 Dose 2
Drug: TAS5315 Dose 2
Treatment period: oral administration for 12 weeks, QD
Experimental: TAS5315 Dose 3
Drug: TAS5315 Dose 3
Treatment period: oral administration for 12 weeks, QD
Experimental: AS5315 Dose 4
Drug: TAS5315 Dose 4
Treatment period: oral administration for 12 weeks, QD
Experimental: TAS5315 Dose 5
Drug: TAS5315 Dose 5
Treatment period: oral administration for 12 weeks, QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline in weekly Urticaria Activity Score (UAS7) at week 12
Time Frame: Week 12

The UAS7 is the sum of the HSS7 score (weekly Hives Severity Sore) and the ISS7 score (weekly Itch Severity Score). The range of the UAS7 score is 0 - 42.

(Zuberbier et al. 1995; Zuberbier et al., 2014)
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete absence of hives and itch (UAS7=0)
Time Frame: Over time from week 1 to week 12
Over time from week 1 to week 12
Disease control (UAS7<=6)
Time Frame: Over time from week 1 to week 12
Over time from week 1 to week 12
Mean change from baseline in weekly Angioedema Activity Score (AAS7)
Time Frame: Over time from week 1 to week 12
The AAS is a validated tool to assess occurrence of episodes of angioedema. The AAS7 is a weekly AAS score (AAS7). Minimum and maximum possible AAS7 scores are 0-105.
Over time from week 1 to week 12
Mean change from baseline in Dermatology life quality index (DLQI)
Time Frame: Over time from week 1 to week 12
DLQI is a 10-item dermatology-specific quality of life (QoL) measure. The range of the DLQI score is 0 - 30.
Over time from week 1 to week 12
Mean change from baseline in Urticaria control test (UCT)
Time Frame: Over time from week 1 to week 12
UCT is 4-item measure, which assesses symptoms, quality of life, treatment effectiveness. The range of the UCT score is 0 - 16.
Over time from week 1 to week 12
Mean change from baseline in pharmacodynamics marker
Time Frame: Over time from week 1to week 12
Pharmacodynamics marker are IgG, IgM, IgA, IgE, CRP and D-dimer.
Over time from week 1to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taiho Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Taiho Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2022

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

April 12, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 19, 2022

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10063040

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Taiho provides a platform for accepting researchers' requests for sharing anonymized, patient-level, analyzable datasets from articles published in peer-reviewed journals about the primary results from Taiho-sponsored interventional clinical trials in patients in which the medicine and the indication has received marketing approval from regulatory authorities in the United States, the European Union, and/or Japan on or after January 15, 2018.

IPD Sharing Time Frame

https://www.taiho.co.jp/en/science/policy/clinical_trial_information_disclosure_policy/index.html

IPD Sharing Access Criteria

Access to the clinical trial data is contingent upon approval of a proposed study protocol by an independent review panel and the execution of a data-sharing agreement with the researcher.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Spontaneous Urticaria

Clinical Trials on TAS5315 Dose 1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe