Status:
COMPLETED
A Phase 2a Study of TAS5315 in Patients With Chronic Spontaneous Urticaria
Lead Sponsor:
Taiho Pharmaceutical Co., Ltd.
Conditions:
Chronic Spontaneous Urticaria
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2023
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT05335499
Start Date
June 28 2022
End Date
December 22 2023
Last Update
August 7 2024
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
A site selected by Taiho Pharmaceutical Co., Ltd.
Ehime, Japan
2
A site selected by Taiho Pharmaceutical Co., Ltd.
Fukuoka, Japan
3
A site selected by Taiho Pharmaceutical Co., Ltd.
Gunma, Japan
4
A site selected by Taiho Pharmaceutical Co., Ltd.
Hiroshima, Japan