A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of BGB-16673 in Adults With Chronic Spontaneous Urticaria

Launched by BEIGENE · Jun 3, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to test a new medication called BGB-16673 in adults who have a condition known as chronic spontaneous urticaria (CSU), which causes persistent itching and hives. The main goals of the study are to see if the medication is safe, how well it is tolerated, and how it works in the body. This study will involve several groups of participants who will receive different doses of the medication or a placebo (a non-active treatment) to compare the effects.

To be eligible for this trial, participants need to have been diagnosed with chronic spontaneous urticaria for at least six months and have experienced itching and hives for at least six consecutive weeks despite taking other allergy medications. Participants will be closely monitored during the study, and their symptoms will be documented. It’s important to note that individuals with specific triggers for their hives or other skin diseases may not be able to join the study. If you or someone you know is interested in participating, you’ll get more information about what to expect throughout the trial, including visits for assessments and monitoring.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • Participants who have a clearly defined, predominating or sole trigger for their chronic 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 the investigators 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 where flares 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.