A Phase 2a Study of TAS5315 in Patients With Chronic Spontaneous Urticaria
Primary Purpose
Chronic Spontaneous Urticaria
Status
Recruiting
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
TAS5315 Dose 1
TAS5315 Dose 2
TAS5315 Dose 3
TAS5315 Dose 4
TAS5315 Dose 5
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Spontaneous Urticaria
Eligibility 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
Sites / Locations
- A site selected by Taiho Pharmaceutical Co., Ltd.Recruiting
- A site selected by Taiho Pharmaceutical Co., Ltd.Recruiting
- A site selected by Taiho Pharmaceutical Co., Ltd.Recruiting
- A site selected by Taiho Pharmaceutical Co., Ltd.Recruiting
- A site selected by Taiho Pharmaceutical Co., Ltd.Recruiting
- A site selected by Taiho Pharmaceutical Co., Ltd.Recruiting
- A site selected by Taiho Pharmaceutical Co., Ltd.Recruiting
- A site selected by Taiho Pharmaceutical Co., Ltd.Recruiting
- A site selected by Taiho Pharmaceutical Co., Ltd.Recruiting
- A site selected by Taiho Pharmaceutical Co., Ltd.Recruiting
- A site selected by Taiho Pharmaceutical Co., Ltd.Recruiting
- A site selected by Taiho Pharmaceutical Co., Ltd.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
TAS5315 Dose 1
TAS5315 Dose 2
TAS5315 Dose 3
AS5315 Dose 4
TAS5315 Dose 5
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Complete absence of hives and itch (UAS7=0)
Disease control (UAS7<=6)
Mean change from baseline in weekly Angioedema Activity Score (AAS7)
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)
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)
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
Pharmacodynamics marker are IgG, IgM, IgA, IgE, CRP and D-dimer.
Full Information
NCT ID
NCT05335499
First Posted
April 12, 2022
Last Updated
August 4, 2023
Sponsor
Taiho Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05335499
Brief Title
A Phase 2a Study of TAS5315 in Patients With Chronic Spontaneous Urticaria
Official Title
A Phase 2a, Randomized, Double-blind, Study of TAS5315 in Chronic Spontaneous Urticaria Patients With an Inadequate Response to H1-antihistamines
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Spontaneous Urticaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAS5315 Dose 1
Arm Type
Experimental
Arm Title
TAS5315 Dose 2
Arm Type
Experimental
Arm Title
TAS5315 Dose 3
Arm Type
Experimental
Arm Title
AS5315 Dose 4
Arm Type
Experimental
Arm Title
TAS5315 Dose 5
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TAS5315 Dose 1
Intervention Description
Treatment period: oral administration for 12 weeks, QD
Intervention Type
Drug
Intervention Name(s)
TAS5315 Dose 2
Intervention Description
Treatment period: oral administration for 12 weeks, QD
Intervention Type
Drug
Intervention Name(s)
TAS5315 Dose 3
Intervention Description
Treatment period: oral administration for 12 weeks, QD
Intervention Type
Drug
Intervention Name(s)
TAS5315 Dose 4
Intervention Description
Treatment period: oral administration for 12 weeks, QD
Intervention Type
Drug
Intervention Name(s)
TAS5315 Dose 5
Intervention Description
Treatment period: oral administration for 12 weeks, QD
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Screening period: oral administration for 2 weeks, QD
Treatment period: oral administration for 12 weeks, QD
Primary Outcome Measure Information:
Title
Mean change from baseline in weekly Urticaria Activity Score (UAS7) at week 12
Description
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)
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Complete absence of hives and itch (UAS7=0)
Time Frame
Over time from week 1 to week 12
Title
Disease control (UAS7<=6)
Time Frame
Over time from week 1 to week 12
Title
Mean change from baseline in weekly Angioedema Activity Score (AAS7)
Description
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.
Time Frame
Over time from week 1 to week 12
Title
Mean change from baseline in Dermatology life quality index (DLQI)
Description
DLQI is a 10-item dermatology-specific quality of life (QoL) measure. The range of the DLQI score is 0 - 30.
Time Frame
Over time from week 1 to week 12
Title
Mean change from baseline in Urticaria control test (UCT)
Description
UCT is 4-item measure, which assesses symptoms, quality of life, treatment effectiveness. The range of the UCT score is 0 - 16.
Time Frame
Over time from week 1 to week 12
Title
Mean change from baseline in pharmacodynamics marker
Description
Pharmacodynamics marker are IgG, IgM, IgA, IgE, CRP and D-dimer.
Time Frame
Over time from week 1to week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Drug Information Center
Phone
+81-3-3294-4527
Email
th-tas5315_clinical@taiho.co.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taiho Pharmaceutical Co., Ltd.
Organizational Affiliation
Taiho Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
A site selected by Taiho Pharmaceutical Co., Ltd.
City
Ehime
Country
Japan
Individual Site Status
Recruiting
Facility Name
A site selected by Taiho Pharmaceutical Co., Ltd.
City
Fukuoka
Country
Japan
Individual Site Status
Recruiting
Facility Name
A site selected by Taiho Pharmaceutical Co., Ltd.
City
Gunma
Country
Japan
Individual Site Status
Recruiting
Facility Name
A site selected by Taiho Pharmaceutical Co., Ltd.
City
Hiroshima
Country
Japan
Individual Site Status
Recruiting
Facility Name
A site selected by Taiho Pharmaceutical Co., Ltd.
City
Ishikawa
Country
Japan
Individual Site Status
Recruiting
Facility Name
A site selected by Taiho Pharmaceutical Co., Ltd.
City
Kagawa
Country
Japan
Individual Site Status
Recruiting
Facility Name
A site selected by Taiho Pharmaceutical Co., Ltd.
City
Kumamoto
Country
Japan
Individual Site Status
Recruiting
Facility Name
A site selected by Taiho Pharmaceutical Co., Ltd.
City
Obihiro
Country
Japan
Individual Site Status
Recruiting
Facility Name
A site selected by Taiho Pharmaceutical Co., Ltd.
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Name
A site selected by Taiho Pharmaceutical Co., Ltd.
City
Sapporo
Country
Japan
Individual Site Status
Recruiting
Facility Name
A site selected by Taiho Pharmaceutical Co., Ltd.
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
A site selected by Taiho Pharmaceutical Co., Ltd.
City
Yokohama
Country
Japan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
https://www.taiho.co.jp/en/science/policy/clinical_trial_information_disclosure_policy/index.html
IPD Sharing Access Criteria
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.
IPD Sharing URL
https://vivli.org/
Citations:
PubMed Identifier
8651031
Citation
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.
Results Reference
background
PubMed Identifier
24785199
Citation
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.
Results Reference
background
Links:
URL
http://www.ga2len.net
Description
Copyright for UAS: Global Allergy and Asthma European Network (GA²LEN).
Learn more about this trial
A Phase 2a Study of TAS5315 in Patients With Chronic Spontaneous Urticaria
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