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Clinical trial

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

ID
Name
10063040
Description
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
Trial arms
Trial start
2022-06-28
Estimated PCD
2024-03-01
Trial end
2024-03-01
Status
Recruiting
Phase
Early phase I
Treatment
TAS5315 Dose 1
Treatment period: oral administration for 12 weeks, QD
Arms:
TAS5315 Dose 1
TAS5315 Dose 2
Treatment period: oral administration for 12 weeks, QD
Arms:
TAS5315 Dose 2
TAS5315 Dose 3
Treatment period: oral administration for 12 weeks, QD
Arms:
TAS5315 Dose 3
TAS5315 Dose 4
Treatment period: oral administration for 12 weeks, QD
Arms:
AS5315 Dose 4
TAS5315 Dose 5
Treatment period: oral administration for 12 weeks, QD
Arms:
TAS5315 Dose 5
Placebo
* Screening period: oral administration for 2 weeks, QD * Treatment period: oral administration for 12 weeks, QD
Arms:
Placebo
Size
120
Primary endpoint
Mean change from baseline in weekly Urticaria Activity Score (UAS7) at week 12
Week 12
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}
Updated at
2024-02-08

1 organization

2 products

1 indication

Product
TAS5315
Indication
Chronic Spontaneous Urticaria
Organization
Taiho Pharmaceutical
Product
Placebo