A Phase 2a Study of TAS5315 in Patients With Chronic Spontaneous Urticaria
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TAS5315 Dose 1
|
Drug: TAS5315 Dose 1
Treatment period: oral administration for 12 weeks, QD
|
| Experimental: TAS5315 Dose 2
|
Drug: TAS5315 Dose 2
Treatment period: oral administration for 12 weeks, QD
|
| Experimental: TAS5315 Dose 3
|
Drug: TAS5315 Dose 3
Treatment period: oral administration for 12 weeks, QD
|
| Experimental: AS5315 Dose 4
|
Drug: TAS5315 Dose 4
Treatment period: oral administration for 12 weeks, QD
|
| Experimental: TAS5315 Dose 5
|
Drug: TAS5315 Dose 5
Treatment period: oral administration for 12 weeks, QD
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Screening period: oral administration for 2 weeks, QD
Treatment period: oral administration for 12 weeks, QD
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | A site selected by Taiho Pharmaceutical Co., Ltd. | Fukuoka | Japan | ||
| 2 | A site selected by Taiho Pharmaceutical Co., Ltd. | Kumamoto | Japan | ||
| 3 | A site selected by Taiho Pharmaceutical Co., Ltd. | Sapporo | Japan | ||
| 4 | A site selected by Taiho Pharmaceutical Co., Ltd. | Tokyo | Japan | ||
| 5 | A site selected by Taiho Pharmaceutical Co., Ltd. | Yokohama | Japan |
Sponsors and Collaborators
- Taiho Pharmaceutical Co., Ltd.
Investigators
- Study Director: Taiho Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Zuberbier T, Aberer W, Asero R, Bindslev-Jensen C, Brzoza Z, Canonica GW, Church MK, Ensina LF, Giménez-Arnau A, Godse K, Gonçalo M, Grattan C, Hebert J, Hide M, Kaplan A, Kapp A, Abdul Latiff AH, Mathelier-Fusade P, Metz M, Nast A, Saini SS, Sánchez-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.
- 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.
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