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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

126

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jun 2022

Shorter than P25 for phase_2

Geographic Reach

1 country

12 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

First Submitted

Initial submission to the registry

April 12, 2022

Completed

7 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed

2 months until next milestone

Study Start

First participant enrolled

June 28, 2022

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2023

Completed

Last Updated

August 7, 2024

Status Verified

February 1, 2024

Enrollment Period

1.5 years

First QC Date

April 12, 2022

Last Update Submit

August 6, 2024

Conditions

Chronic Spontaneous Urticaria

Outcome Measures

Primary Outcomes (1)

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 Outcomes (6)

Complete absence of hives and itch (UAS7=0)
Over time from week 1 to week 12
Disease control (UAS7<=6)
Over time from week 1 to week 12
Mean change from baseline in weekly Angioedema Activity Score (AAS7)
Over time from week 1 to week 12
Mean change from baseline in Dermatology life quality index (DLQI)
Over time from week 1 to week 12
Mean change from baseline in Urticaria control test (UCT)
Over time from week 1 to week 12
+1 more secondary outcomes

Study Arms (6)

TAS5315 Dose 1

EXPERIMENTAL

Drug: TAS5315 Dose 1

TAS5315 Dose 2

EXPERIMENTAL

Drug: TAS5315 Dose 2

TAS5315 Dose 3

EXPERIMENTAL

Drug: TAS5315 Dose 3

AS5315 Dose 4

EXPERIMENTAL

Drug: TAS5315 Dose 4

TAS5315 Dose 5

EXPERIMENTAL

Drug: TAS5315 Dose 5

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TAS5315 Dose 1DRUG

Treatment period: oral administration for 12 weeks, QD

TAS5315 Dose 1

TAS5315 Dose 2DRUG

Treatment period: oral administration for 12 weeks, QD

TAS5315 Dose 2

TAS5315 Dose 3DRUG

Treatment period: oral administration for 12 weeks, QD

TAS5315 Dose 3

TAS5315 Dose 4DRUG

Treatment period: oral administration for 12 weeks, QD

AS5315 Dose 4

TAS5315 Dose 5DRUG

Treatment period: oral administration for 12 weeks, QD

TAS5315 Dose 5

PlaceboDRUG

* Screening period: oral administration for 2 weeks, QD * Treatment period: oral administration for 12 weeks, QD

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.