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

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

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

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