A Phase 2a Study of TAS5315 in Patients With Chronic Spontaneous Urticaria
- Conditions
- Chronic Spontaneous Urticaria
- Interventions
- Drug: TAS5315 Dose 2Drug: PlaceboDrug: TAS5315 Dose 1Drug: TAS5315 Dose 3Drug: TAS5315 Dose 4Drug: TAS5315 Dose 5
- Registration Number
- NCT05335499
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
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
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TAS5315 Dose 2 TAS5315 Dose 2 - Placebo Placebo - TAS5315 Dose 1 TAS5315 Dose 1 - TAS5315 Dose 3 TAS5315 Dose 3 - AS5315 Dose 4 TAS5315 Dose 4 - TAS5315 Dose 5 TAS5315 Dose 5 -
- Primary Outcome Measures
Name Time Method Mean change from baseline in weekly Urticaria Activity Score (UAS7) at week 12 Week 12 The UAS7 is the sum of the HSS7 score (weekly Hives Severity Sore) and the ISS7 score (weekly Itch Severity Score). The range of the UAS7 score is 0 - 42.
(Zuberbier et al. 1995; Zuberbier et al., 2014)
- Secondary Outcome Measures
Name Time Method Complete absence of hives and itch (UAS7=0) Over time from week 1 to week 12 Disease control (UAS7<=6) Over time from week 1 to week 12 Mean change from baseline in weekly Angioedema Activity Score (AAS7) Over time from week 1 to week 12 The AAS is a validated tool to assess occurrence of episodes of angioedema. The AAS7 is a weekly AAS score (AAS7). Minimum and maximum possible AAS7 scores are 0-105.
Mean change from baseline in Dermatology life quality index (DLQI) Over time from week 1 to week 12 DLQI is a 10-item dermatology-specific quality of life (QoL) measure. The range of the DLQI score is 0 - 30.
Mean change from baseline in Urticaria control test (UCT) Over time from week 1 to week 12 UCT is 4-item measure, which assesses symptoms, quality of life, treatment effectiveness. The range of the UCT score is 0 - 16.
Mean change from baseline in pharmacodynamics marker Over time from week 1to week 12 Pharmacodynamics marker are IgG, IgM, IgA, IgE, CRP and D-dimer.
Trial Locations
- Locations (1)
A site selected by Taiho Pharmaceutical Co., Ltd.
🇯🇵Yokohama, Japan