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

JRCT ID: jRCT2031210693

Registered date:15/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: chronic spontaneous urticaria
• Date of first enrollment: 28/06/2022
• Target sample size: 120
• Study type: Interventional
• Intervention(s): Oral administration of TAS5315 0.25 to 4 mg, QD

Outcome(s)

• Primary Outcome: Mean change from baseline in weekly Urticaria Activity Score (UAS7) at week 12
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Ali Nasermoaddeli