JPRN-jRCT2031210693RecruitingPhase 2
A Phase 2a, randomized, double-blind, study of TAS5315 in chronic spontaneous urticaria patients with an inadequate response to H1-antihistamines
Ali Nasermoaddeli0 sites120 target enrollmentStarted: April 15, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 18age old to <= 75age old (—)
- Sex
- All
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
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