A Phase 2a Study of TAS5315 in Patients With Chronic Spontaneous Urticaria
NCT ID: NCT05335499
Last Updated: 2024-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
126 participants
INTERVENTIONAL
2022-06-28
2023-12-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TAS5315 Dose 1
TAS5315 Dose 1
Treatment period: oral administration for 12 weeks, QD
TAS5315 Dose 2
TAS5315 Dose 2
Treatment period: oral administration for 12 weeks, QD
TAS5315 Dose 3
TAS5315 Dose 3
Treatment period: oral administration for 12 weeks, QD
AS5315 Dose 4
TAS5315 Dose 4
Treatment period: oral administration for 12 weeks, QD
TAS5315 Dose 5
TAS5315 Dose 5
Treatment period: oral administration for 12 weeks, QD
Placebo
Placebo
* Screening period: oral administration for 2 weeks, QD
* Treatment period: oral administration for 12 weeks, QD
Interventions
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TAS5315 Dose 1
Treatment period: oral administration for 12 weeks, QD
TAS5315 Dose 2
Treatment period: oral administration for 12 weeks, QD
TAS5315 Dose 3
Treatment period: oral administration for 12 weeks, QD
TAS5315 Dose 4
Treatment period: oral administration for 12 weeks, QD
TAS5315 Dose 5
Treatment period: oral administration for 12 weeks, QD
Placebo
* Screening period: oral administration for 2 weeks, QD
* Treatment period: oral administration for 12 weeks, QD
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Taiho Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Taiho Pharmaceutical Co., Ltd.
Role: STUDY_DIRECTOR
Taiho Pharmaceutical Co., Ltd.
Locations
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A site selected by Taiho Pharmaceutical Co., Ltd.
Ehime, , Japan
A site selected by Taiho Pharmaceutical Co., Ltd.
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
Countries
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References
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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.
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.
Other Identifiers
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10063040
Identifier Type: -
Identifier Source: org_study_id
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