A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple- Ascending Doses of BGB-16673 in Patients With Chronic Spontaneous Urticaria
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Participants must be diagnosed with chronic spontaneous urticaria (CSU) for ≥ 6 months before randomization.
• The presence of itch and hives for ≥6 consecutive weeks at any time prior to randomization 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 7 days before randomization
• Presence of hives must have been documented within 3 months before randomization
Locations
Other Locations
China
Peking University Third Hospital
RECRUITING
Beijing
Xiangya Hospital of Central South University
RECRUITING
Changsha
Chengdu Second Peoples Hospital
RECRUITING
Chengdu
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Dermatology Hospital of Southern Medical University
RECRUITING
Guangzhou
Hangzhou First Peoples Hospital
RECRUITING
Hangzhou
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Study Director
clinicaltrials@beigene.com
1-877-828-5568
Time Frame
Start Date:2025-07-19
Estimated Completion Date:2026-09-22
Participants
Target number of participants:27
Treatments
Experimental: BGB-16673
Participants will receive BGB-16673 orally
Placebo_comparator: Placebo
Participants will receive placebo orally for 28 days and then crossover to receive BGB-16673.