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

Taiho Pharma

Status and phase: Completed; Phase 2

Conditions: Chronic Spontaneous Urticaria

Treatments: Drug: Placebo; Drug: TAS5315 Dose 4; Drug: TAS5315 Dose 3; Drug: TAS5315 Dose 2; Drug: TAS5315 Dose 5; Drug: TAS5315 Dose 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT05335499

10063040

Details and patient eligibility

About

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

Full 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

Enrollment: 126 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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126 participants in 6 patient groups, including a placebo group

TAS5315 Dose 1

Experimental group

Treatment:

Drug: TAS5315 Dose 1

TAS5315 Dose 2

Experimental group

Treatment:

Drug: TAS5315 Dose 2

TAS5315 Dose 3

Experimental group

Treatment:

Drug: TAS5315 Dose 3

AS5315 Dose 4

Experimental group

Treatment:

Drug: TAS5315 Dose 4

TAS5315 Dose 5

Experimental group

Treatment:

Drug: TAS5315 Dose 5

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo