chronic spontaneous urticaria
Conditions
Interventions
Oral administration of TAS5315 0.25 to 4 mg, QD
Sponsors
Ali Nasermoaddeli
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in weekly Urticaria Activity Score (UAS7) at week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of UAS7(percentage of the complete absence of hives and itch (UAS7=0) and disease control (UAS7<=6)), ISS7, HSS7, UCT, DLQI, UAS (by physician), and AAS7 | — |
Contacts
Public ContactNagaoka Makoto
Taiho Pharmaceutical Co., Ltd.
Outcome results
None listed