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

StatusRecruiting
PhasePhase 1
Started2025-07-19
View on ClinicalTrials.gov ↗

Amendment history

2026-09-03
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v9
Sponsor refiled this as recruiting (was completed)
Primary completion date2026-04-16→2026-11-30
Completion date2026-04-16→2026-11-30
Enrollment target34→58
Study sites8→9
Study arms2→3
Lead sponsorBeiGene→BeOne Medicines
InterventionsBGB-16673 (Drug), Placebo (Drug)→Placebo (Drug), Tacabrutideg (Drug)
Eligibility criteria+222 characters
Inclusion Criteria: Part A Participants must be diagnosed with chronic spontaneous urti [...] t have been documented within 3 months before randomization Part B Participants must be 18 to 55 years of age and healthy, with no clinically relevant abnormalities. Body Mass Index (BMI) of 18 to 32 kg/m^2; and a total body weight > 50 kg (110 lbs). Exclusion Criteria: Part A Participants who have a clearly defined, predominating or so [...] d, dermatitis herpetiformis, senile pruritus, or psoriasis. All Participants Any uncontrolled disease state, including asthma or inflamma [...]
Secondary endpoints8 entries, revised
Part A: Change from Baseline in Weekly Urticaria Activity Score (UAS7) Part A: Change from baseline in weekly Itch Severity Score (ISS7) Part A: Change from baseline in weekly Hives Severity Score (HSS7) Part A: Change from baseline in weekly Angioedema Activity Score (AAS7) Part A: Change from baseline in 7-day recall period version of the Urticaria Control Test (UCT7) Part A: Percentage of participants with complete absence of hives and itch, assessed as UAS7 = 0 Part A: Percentage of participants with UAS7 ≤ 6 response Part A: Levels of Bruton tyrosine kinase (BTK) protein
Primary endpoints10 to 11 entries
Part A: Accumulation Ratio of AUC for BGB-16673tacabrutideg Part A: Accumulation Ratio of Cmax for BGB-16673tacabrutideg Part A: Apparent oral clearance (CL/F) of BGB-16673tacabrutideg Part A: Apparent terminal elimination half life (t1/2) of BGB-16673tacabrutideg Part A: Apparent volume of distribution (Vz/F) of BGB-16673tacabrutideg Part A: Area under the curve (AUC) of BGB-16673tacabrutideg Part A: Maximum observed plasma concentration (Cmax) of BGB-16673tacabrutideg Part A: Minimum observed plasma concentration (Cmin) of BGB-16673tacabrutideg Part A: Number of participants with adverse eve [...] [...]
Study title+43 characters
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of Tacabrutideg (BGB-16673) in Adults With Chronic Spontaneous Urticaria and in Healthy Participants
2026-06-17
Study Status v8
Trial completed
Primary completion dateestimated 2026-04-17→confirmed 2026-04-16
Completion dateestimated 2026-04-17→confirmed 2026-04-16
2026-01-30
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v7
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2026-09-22→2026-04-17
Completion date2026-09-22→2026-04-17
Enrollment targetestimated 27→confirmed 34
Study sitesdetails revised at 8 of 8 sites
2025-11-14
Study Identification, Study Status, Contacts/Locations v6
Study sites10→8
2025-09-19
Study Status, Contacts/Locations v5
Study sites11→10
Show 4 earlier versions
2025-09-11
Study Status, Contacts/Locations v4
Study sitesdetails revised at 1 of 11 sites
2025-08-05
Study Status, Contacts/Locations v3
Study sites10→11
2025-07-24
Study Status v2
Start dateestimated 2025-07→confirmed 2025-07-19
2025-07-03
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2025-06→2025-07
Study sites0→10
2025-06-03
Original filing
This is a Phase 1b study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of multiple-ascending doses of tacabrutideg in adults with chronic spontaneous urticaria (CSU) and in healthy participants.
Trial Details
NCT Number NCT07005713
Lead Sponsor BeOne Medicines
Conditions Chronic Spontaneous Urticaria
Enrollment 58 participants
Start Date 2025-07-19
Primary Completion 2026-11-30 (estimated)
Study Completion 2026-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-09