Phase
Condition
Hives (Urticaria)
Urticaria
Treatment
Placebo
BGB-16673
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must be diagnosed with chronic spontaneous urticaria (CSU) for ≥ 6months before randomization.
The presence of itch and hives for ≥6 consecutive weeks at any time prior torandomization despite the use of second-generation H1-antihistamines
UAS7≥16 and HSS7≥8 during the 7 days before randomization
Participants must not have had any missing UAS7 entry (ISS7 and HSS7) during the 7days before randomization
Presence of hives must have been documented within 3 months before randomization
Exclusion
Exclusion Criteria:
Participants who have a clearly defined, predominating or sole trigger for theirchronic urticaria (chronic inducible urticaria), including urticaria factitia (symptomatic dermographism) or cold, heat, solar, pressure, delayed pressure,aquagenic, cholinergic, or contact urticaria.
Other diseases with symptoms of urticaria or angioedema
Any other skin disease associated with chronic itching that might influence in theinvestigators opinion the study evaluations and results, eg, atopic dermatitis,bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or psoriasis.
Any uncontrolled disease state, including asthma or inflammatory bowel disease whereflares are commonly treated with oral or parenteral corticosteroids.
Significant bleeding risk or coagulopathy.
Prior exposure to any BTK inhibitors or protein degraders.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Connect with a study center
Peking University Third Hospital
Beijing, Beijing Municipality 100000
ChinaSite Not Available
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality 630014
ChinaSite Not Available
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong
ChinaSite Not Available
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong 510515
ChinaSite Not Available
Dermatology Hospital of Southern Medical University
Guangzhou 1809858, Guangdong 1809935
ChinaSite Not Available
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)
Guangzhou 1809858, Guangdong 1809935 510000
ChinaSite Not Available
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei 430022
ChinaSite Not Available
Xiangya Hospital of Central South University
Changsha, Hunan 410008
ChinaSite Not Available
Chengdu Second Peoples Hospital
Chengdu, Sichuan 610021
ChinaSite Not Available
Hangzhou First Peoples Hospital
Hangzhou, Zhejiang 310006
ChinaSite Not Available
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang 325000
ChinaSite Not Available

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