CompletedPhase 1

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

China34 participantsStarted 2025-07-19

Plain-language 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).

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this was a Phase 1 trial that has already completed, what safety signals or side effects showed up in the adverse event data for BGB-16673 that you think are most relevant to my situation with chronic spontaneous urticaria?
2This study was focused on how the drug moves through the body — things like how quickly it's absorbed and how long it stays in the system — so it wasn't primarily designed to test whether it actually reduces my hives or itching; does that mean there are still unanswered questions about whether BGB-16673 actually works, and are there later-phase trials I should know about?
3Given that this trial is now completed, would my doctor be able to access any of the results, and how does what was learned here compare to what's already known about approved treatments for chronic spontaneous urticaria like omalizumab?
4Since this was an early-phase dose-finding study, does the fact that it's finished mean the drug is moving into larger trials, and if so, would it make more sense for me to explore enrolling in one of those instead of trying a treatment that's still in early development?
5Are there standard-of-care options I haven't tried yet that might be a better fit for me right now, while research on BGB-16673 is still in early stages?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with adverse events (AEs)

Timeframe: Up to approximately 4 months

Maximum observed plasma concentration (Cmax) of BGB-16673

Timeframe: Up to approximately 10 weeks

Minimum observed plasma concentration (Cmin) of BGB-16673

Timeframe: Up to approximately 10 weeks

Time to reach maximum observed plasma concentration (Tmax) of BGB-16673

Timeframe: Up to approximately 10 weeks

Apparent terminal elimination half life (t1/2) of BGB-16673

Timeframe: Up to approximately 10 weeks

Area under the curve (AUC) of BGB-16673

Timeframe: Up to approximately 10 weeks

Apparent oral clearance (CL/F) of BGB-16673

Timeframe: Up to approximately 10 weeks

Trial details

NCT IDNCT07005713

SponsorBeiGene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-16

View on ClinicalTrials.gov More Chronic Spontaneous Urticaria trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of participants with adverse events (AEs)

Timeframe: Up to approximately 4 months

Maximum observed plasma concentration (Cmax) of BGB-16673

Timeframe: Up to approximately 10 weeks

Minimum observed plasma concentration (Cmin) of BGB-16673

Timeframe: Up to approximately 10 weeks

Time to reach maximum observed plasma concentration (Tmax) of BGB-16673

Timeframe: Up to approximately 10 weeks

Apparent terminal elimination half life (t1/2) of BGB-16673

Timeframe: Up to approximately 10 weeks

Area under the curve (AUC) of BGB-16673

Timeframe: Up to approximately 10 weeks

Apparent oral clearance (CL/F) of BGB-16673

Timeframe: Up to approximately 10 weeks