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

Phase 1

Not yet recruiting

• Conditions: Chronic Spontaneous Urticaria
• Interventions: Drug: BGB-16673; Drug: Placebo

• Registration Number: NCT07005713
• Lead Sponsor: BeiGene

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-22
• Status Verified: 2025-06
• Study Start: 2025-06
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-05
• Last Update Posted: 2025-06-05
• Primary Completion: 2026-09-22
• Study Completion: 2026-09-22

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
BGB-16673	BGB-16673	Participants will receive BGB-16673 orally
Placebo	BGB-16673	Participants will receive placebo orally for 28 days and then crossover to receive BGB-16673.
Placebo	Placebo	Participants will receive placebo orally for 28 days and then crossover to receive BGB-16673.

Primary Outcome Measures

Name	Time	Method
Apparent terminal elimination half life (t1/2) of BGB-16673	Up to approximately 10 weeks
Area under the curve (AUC) of BGB-16673	Up to approximately 10 weeks
Apparent oral clearance (CL/F) of BGB-16673	Up to approximately 10 weeks
Apparent volume of distribution (Vz/F) of BGB-16673	Up to approximately 10 weeks
Accumulation Ratio of AUC for BGB-16673	Up to approximately 10 weeks
Accumulation Ratio of Cmax for BGB-16673	Up to approximately 10 weeks
Number of participants with adverse events (AEs)	Up to approximately 4 months	Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including findings from laboratory tests and electrocardiogram results.
Maximum observed plasma concentration (Cmax) of BGB-16673	Up to approximately 10 weeks
Minimum observed plasma concentration (Cmin) of BGB-16673	Up to approximately 10 weeks
Time to reach maximum observed plasma concentration (Tmax) of BGB-16673	Up to approximately 10 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of participants with UAS7 ≤ 6 response	Up to approximately 3 months
Levels of Bruton tyrosine kinase (BTK) protein	Up to approximately 3 months
Change from Baseline in Weekly Urticaria Activity Score (UAS7)	Baseline and up to approximately 3 months	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.
Change from baseline in weekly Itch Severity Score (ISS7)	Baseline and up to approximately 3 months	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.
Change from baseline in weekly Hives Severity Score (HSS7)	Baseline and up to approximately 3 months	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.
Change from baseline in weekly Angioedema Activity Score (AAS7)	Baseline and up to approximately 3 months	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.
Change from baseline in 7-day recall period version of the Urticaria Control Test (UCT7)	Baseline and up to approximately 3 months	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.
Percentage of participants with complete absence of hives and itch, assessed as UAS7 = 0	Up to approximately 3 months