A phase 2a study of TAS5315 in patients with chronic spontaneous urticaria
- Conditions
- chronic spontaneous urticaria
- Registration Number
- JPRN-jRCT2031210693
- Lead Sponsor
- Ali Nasermoaddeli
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
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
- 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
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method