Chronic Spontaneous Urticaria
Conditions
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
Interventions
DRUGTAS5315 Dose 1
Treatment period: oral administration for 12 weeks, QD
DRUGTAS5315 Dose 2
Treatment period: oral administration for 12 weeks, QD
DRUGTAS5315 Dose 3
Treatment period: oral administration for 12 weeks, QD
DRUGTAS5315 Dose 4
Treatment period: oral administration for 12 weeks, QD
DRUGTAS5315 Dose 5
Treatment period: oral administration for 12 weeks, QD
DRUGPlacebo
* Screening period: oral administration for 2 weeks, QD * Treatment period: oral administration for 12 weeks, QD
Sponsors
Taiho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Complete absence of hives and itch (UAS7=0) | Over time from week 1 to week 12 | — |
| 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. |
| 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. |
Countries
Japan
Outcome results
None listed