This study is a Phase 1b, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of multiple-ascending doses of BGB-16673 in adults with chronic spontaneous urticaria (CSU).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
34
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Number of participants with adverse events (AEs)
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including findings from laboratory tests and electrocardiogram results.
Time frame: Up to approximately 4 months
Maximum observed plasma concentration (Cmax) of BGB-16673
Time frame: Up to approximately 10 weeks
Minimum observed plasma concentration (Cmin) of BGB-16673
Time frame: Up to approximately 10 weeks
Time to reach maximum observed plasma concentration (Tmax) of BGB-16673
Time frame: Up to approximately 10 weeks
Apparent terminal elimination half life (t1/2) of BGB-16673
Time frame: Up to approximately 10 weeks
Area under the curve (AUC) of BGB-16673
Time frame: Up to approximately 10 weeks
Apparent oral clearance (CL/F) of BGB-16673
Time frame: Up to approximately 10 weeks
Apparent volume of distribution (Vz/F) of BGB-16673
Time frame: Up to approximately 10 weeks
Accumulation Ratio of AUC for BGB-16673
Time frame: Up to approximately 10 weeks
Accumulation Ratio of Cmax for BGB-16673
Time frame: Up to approximately 10 weeks
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Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Chengdu Second Peoples Hospital
Chengdu, Sichuan, China
Hangzhou First Peoples Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Change from Baseline in Weekly Urticaria Activity Score (UAS7)
The UAS7 consists of an assessment of both hives and itch severity to provide a measure of disease activity. The UAS7 is the sum of the weekly Hives Severity Score (HSS7) and the weekly Itch Severity Score (ISS7) and ranges between 0 and 42. A UAS7 score of 0 signifies that the patient is symptom free, and high UAS7 scores indicate severe symptoms.
Time frame: Baseline and up to approximately 3 months
Change from baseline in weekly Itch Severity Score (ISS7)
The Itch Severity Score (ISS) is a measure of itching. Daily scores range from 0 (no itching) to 3 (intense itching). The ISS7 is a weekly score derived by adding up the daily ISS scores of the past 7 days and ranges from 0 to 21.
Time frame: Baseline and up to approximately 3 months
Change from baseline in weekly Hives Severity Score (HSS7)
The Hives Severity Score (HSS) is a measure of the number of hives present recorded by the participant. Daily scores range from 0 (no hives) to 3 (intense/severe hives). HSS7 is the sum of the daily HSS scores over the past 7 days and ranges from 0 to 21.
Time frame: Baseline and up to approximately 3 months
Change from baseline in weekly Angioedema Activity Score (AAS7)
The Angioedema Activity Score (AAS) is a validated tool designed and verified to measure disease activity, assess response to treatment, and optimize the treatment plan for patients with recurrent angioedema. Responses are filled out prospectively and daily, evaluating five main factors related to angioedema: duration, physical discomfort caused, impact on daily activities, effect on appearance, and overall severity, each scored between 0 and 3. Daily AAS scores can range daily from 0 to 15, and weekly (AAS7) from 0 to 105. Higher AAS scores indicate frequent and severe attacks. Lower scores indicate well-controlled symptoms.
Time frame: Baseline and up to approximately 3 months
Change from baseline in 7-day recall period version of the Urticaria Control Test (UCT7)
UCT7 is a validated questionnaire used to measure the quality of life of patients with chronic urticaria and angioedema. It contains 4 questions, each of which inquires about the extent of impairment in the previous 7 days, with 5 options for answers ranging from "not at all" to "very much." The first question asks about the frequency of all symptoms combined (itching, hives, and/or swelling). The second question asks about the overall impact on quality of life. The third question asks how often treatment has been insufficient to control symptoms, and the final question asks about how well the disease has been controlled. Answers are scored from 0 to 4 (the total score will range from 0 to 16), with higher scores representing milder and better-controlled urticaria and angioedema. The recall period for this questionnaire is 7 days.
Time frame: Baseline and up to approximately 3 months
Percentage of participants with complete absence of hives and itch, assessed as UAS7 = 0
Time frame: Up to approximately 3 months
Percentage of participants with UAS7 ≤ 6 response
Time frame: Up to approximately 3 months
Levels of Bruton tyrosine kinase (BTK) protein
Time frame: Up to approximately 3 months