A Phase 2a Study of TAS5315 in Patients With Chronic Spontaneous Urticaria

Chronic Spontaneous Urticaria Clinical Trial

Official title:

A Phase 2a, Randomized, Double-blind, Study of TAS5315 in Chronic Spontaneous Urticaria Patients With an Inadequate Response to H1-antihistamines

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05335499
• Other study ID #: 10063040
• Status: Recruiting
• Phase: Phase 2
• Start date: June 28, 2022
• Est. completion date: March 2024

Study information

• Verified date: February 2024
• Source: Taiho Pharmaceutical Co., Ltd.
• Contact: Drug Information Center
• Phone: +81-3-3294-4527
• Email: th-tas5315_clinical[@]taiho.co.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Spontaneous Urticaria
• Chronic Urticaria
• Urticaria

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Japan	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

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Complete absence of hives and itch (UAS7=0)		Over time from week 1 to week 12
Secondary	Disease control (UAS7<=6)		Over time from week 1 to week 12
Secondary	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.	Over time from week 1 to week 12
Secondary	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
Secondary	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
Secondary	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

External Links

•   Copyright for UAS: Global Allergy and Asthma European Network (GA²LEN).