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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAS5315 Dose 1 | Experimental |
| |
| TAS5315 Dose 2 | Experimental |
| |
| TAS5315 Dose 3 | Experimental |
| |
| AS5315 Dose 4 | Experimental |
| |
| TAS5315 Dose 5 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAS5315 Dose 1 | Drug | Treatment period: oral administration for 12 weeks, QD |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in weekly Urticaria Activity Score (UAS7) at 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) | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Key Inclusion Criteria:
Key Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Taiho Pharmaceutical Co., Ltd. | Taiho Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A site selected by Taiho Pharmaceutical Co., Ltd. | Ehime | Japan | ||||
| A site selected by Taiho Pharmaceutical Co., Ltd. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8651031 | Background | Zuberbier T, Chantraine-Hess S, Hartmann K, Czarnetzki BM. Pseudoallergen-free diet in the treatment of chronic urticaria. A prospective study. Acta Derm Venereol. 1995 Nov;75(6):484-7. doi: 10.2340/0001555575484487. | |
| 24785199 | Background | Zuberbier T, Aberer W, Asero R, Bindslev-Jensen C, Brzoza Z, Canonica GW, Church MK, Ensina LF, Gimenez-Arnau A, Godse K, Goncalo M, Grattan C, Hebert J, Hide M, Kaplan A, Kapp A, Abdul Latiff AH, Mathelier-Fusade P, Metz M, Nast A, Saini SS, Sanchez-Borges M, Schmid-Grendelmeier P, Simons FE, Staubach P, Sussman G, Toubi E, Vena GA, Wedi B, Zhu XJ, Maurer M; European Academy of Allergy and Clinical Immunology; Global Allergy and Asthma European Network; European Dermatology Forum; World Allergy Organization. The EAACI/GA(2) LEN/EDF/WAO Guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update. Allergy. 2014 Jul;69(7):868-87. doi: 10.1111/all.12313. Epub 2014 Apr 30. |
| Label | URL |
|---|---|
| Copyright for UAS: Global Allergy and Asthma European Network (GA²LEN). | View source |
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Taiho provides a platform for accepting researchers' requests for sharing anonymized, patient-level, analyzable datasets from articles published in peer-reviewed journals about the primary results from Taiho-sponsored interventional clinical trials in patients in which the medicine and the indication has received marketing approval from regulatory authorities in the United States, the European Union, and/or Japan on or after January 15, 2018.
Access to the clinical trial data is contingent upon approval of a proposed study protocol by an independent review panel and the execution of a data-sharing agreement with the researcher.
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| TAS5315 Dose 2 |
| Drug |
Treatment period: oral administration for 12 weeks, QD |
|
| TAS5315 Dose 3 | Drug | Treatment period: oral administration for 12 weeks, QD |
|
| TAS5315 Dose 4 | Drug | Treatment period: oral administration for 12 weeks, QD |
|
| TAS5315 Dose 5 | Drug | Treatment period: oral administration for 12 weeks, QD |
|
| Placebo | Drug |
|
|
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. |
| Over time from week 1 to week 12 |
| Mean change from baseline in Dermatology life quality index (DLQI) | DLQI is a 10-item dermatology-specific quality of life (QoL) measure. The range of the DLQI score is 0 - 30. | Over time from week 1 to week 12 |
| Mean change from baseline in Urticaria control test (UCT) | UCT is 4-item measure, which assesses symptoms, quality of life, treatment effectiveness. The range of the UCT score is 0 - 16. | Over time from week 1 to week 12 |
| Mean change from baseline in pharmacodynamics marker | Pharmacodynamics marker are IgG, IgM, IgA, IgE, CRP and D-dimer. | Over time from week 1to week 12 |
| Fukuoka |
| Japan |
| A site selected by Taiho Pharmaceutical Co., Ltd. | Gunma | Japan |
| A site selected by Taiho Pharmaceutical Co., Ltd. | Hiroshima | Japan |
| A site selected by Taiho Pharmaceutical Co., Ltd. | Ishikawa | Japan |
| A site selected by Taiho Pharmaceutical Co., Ltd. | Kagawa | Japan |
| A site selected by Taiho Pharmaceutical Co., Ltd. | Kumamoto | Japan |
| A site selected by Taiho Pharmaceutical Co., Ltd. | Obihiro | Japan |
| A site selected by Taiho Pharmaceutical Co., Ltd. | Osaka | Japan |
| A site selected by Taiho Pharmaceutical Co., Ltd. | Sapporo | Japan |
| A site selected by Taiho Pharmaceutical Co., Ltd. | Tokyo | Japan |
| A site selected by Taiho Pharmaceutical Co., Ltd. | Yokohama | Japan |
| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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