Clinical trial NCT05335499: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Spontaneous Urticaria
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-19
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Mean change from baseline in weekly Urticaria Activity Score (UAS7) at week 12
timeFrame: Week 12
Secondary outcomes:
measure: Complete absence of hives and itch (UAS7=0)
timeFrame: Over time from week 1 to week 12
measure: Disease control (UAS7<=6)
timeFrame: Over time from week 1 to week 12
measure: Mean change from baseline in weekly Angioedema Activity Score (AAS7)
timeFrame: Over time from week 1 to week 12
measure: Mean change from baseline in Dermatology life quality index (DLQI)
timeFrame: Over time from week 1 to week 12
measure: Mean change from baseline in Urticaria control test (UCT)
timeFrame: Over time from week 1 to week 12
measure: Mean change from baseline in pharmacodynamics marker
timeFrame: Over time from week 1to week 12
Other outcomes:
Locations:
city: Ehime
country: Japan
facility: A site selected by Taiho Pharmaceutical Co., Ltd.
city: Fukuoka
country: Japan
facility: A site selected by Taiho Pharmaceutical Co., Ltd.
city: Gunma
country: Japan
facility: A site selected by Taiho Pharmaceutical Co., Ltd.
city: Hiroshima
country: Japan
facility: A site selected by Taiho Pharmaceutical Co., Ltd.
city: Ishikawa
country: Japan
facility: A site selected by Taiho Pharmaceutical Co., Ltd.
city: Kagawa
country: Japan
facility: A site selected by Taiho Pharmaceutical Co., Ltd.
city: Kumamoto
country: Japan
facility: A site selected by Taiho Pharmaceutical Co., Ltd.
city: Obihiro
country: Japan
facility: A site selected by Taiho Pharmaceutical Co., Ltd.
city: Osaka
country: Japan
facility: A site selected by Taiho Pharmaceutical Co., Ltd.
city: Sapporo
country: Japan
facility: A site selected by Taiho Pharmaceutical Co., Ltd.
city: Tokyo
country: Japan
facility: A site selected by Taiho Pharmaceutical Co., Ltd.
city: Yokohama
country: Japan
facility: A site selected by Taiho Pharmaceutical Co., Ltd.
Study officials:
affiliation: Taiho Pharmaceutical Co., Ltd.
name: Taiho Pharmaceutical Co., Ltd.
role: STUDY_DIRECTOR
References:
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.
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.