Skip to main content
OpenTrials
Completed

NCT Number: NCT05335499

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Spontaneous Urticaria Chronic Disease Chronic Urticaria Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

A site selected by Taiho Pharmaceutical Co., Ltd., Ehime, Japan

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAS5315 Dose 1

Drug

Treatment period: oral administration for 12 weeks, QD

TAS5315 Dose 2

Drug

Treatment period: oral administration for 12 weeks, QD

TAS5315 Dose 3

Drug

Treatment period: oral administration for 12 weeks, QD

TAS5315 Dose 4

Drug

Treatment period: oral administration for 12 weeks, QD

TAS5315 Dose 5

Drug

Treatment period: oral administration for 12 weeks, QD

Placebo

Drug
  • Screening period: oral administration for 2 weeks, QD
  • Treatment period: oral administration for 12 weeks, QD

Primary outcomes

  1. 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)

Secondary outcomes

  1. Complete absence of hives and itch (UAS7=0)

    Time frame: Over time from week 1 to week 12

  2. Disease control (UAS7<=6)

    Time frame: Over time from week 1 to week 12

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Taiho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2022
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.