A phase 2a study of TAS5315 in patients with chronic spontaneous urticaria

Completed

• Conditions: chronic spontaneous urticaria

• Registration Number: jRCT2031210693
• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-15
• Study Start: 2022-06-28
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 120

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

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 & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
-		Mean change from baseline in weekly Urticaria Activity Score (UAS7) at week 12

Secondary Outcome Measures

Name	Time	Method
UAS7		percentage of the complete absence of hives and itch (UAS7=0) and disease control (UAS7<=6)