A Phase 1 interventional study of Tacabrutideg and Placebo in Chronic Spontaneous Urticaria, sponsored by BeOne Medicines. Recruiting at 9 sites in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by BeOne Medicines · Phase 1, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 34 studies in Chronic Urticaria with a site in China — 16 open to participants now, 20 under way, 5 of them phase 3. Chronic Urticaria · China.
Among the 34 studies in Chronic Urticaria with a site in China, this one is the 20th largest by planned enrollment of the 30 interventional ones that give a count, is one of 5 that started in 2025, is one of 7 in phase 1, reaches primary completion later than 5 of the 19 other live ones, and was the 19th registered.
196 studies on the registry are indexed under Chronic Urticaria; 48 are open to participants now.
Browse Chronic Urticaria studies →16 of the 34 studies in Chronic Urticaria with a site in China are open now. Recruiting first, the newest first:
Novelty Nobility, Inc. · Sites in China
Ages 18–75 · Healthy volunteers
Bambusa Therapeutics · Sites in China
Ages 18–75 · Healthy volunteers
Yuhan Corporation · Sites in China, Bulgaria, Poland and 1 more country
Ages 18–75
Jemincare · Sites in China
Ages 18+
Beijing InnoCare Pharma Tech Co., Ltd. · Sites in China
Ages 18–75
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 25 Chronic Urticaria studies recruiting now, 11 (44%) set no upper age limit and 10 (40%) stop at 75 or younger; 1 takes children under 18; 6 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
34 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 13 · Phase 3 10
First in 2013; this study’s year is marked. 5 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 58 is below the median of 80 across 147 interventional studies indexed under Chronic Urticaria.
Median enrollment 110 across the 30 interventional studies, 270 across the 4 observational. Of the 13 that completed or were terminated, 3 (23%) have results posted.
This tab as a report to print or save as PDF → With an account.
30 of 34 have an industry lead sponsor. The 10 most frequent:
BeOne Medicines is the lead sponsor of 69 studies on the registry; 49 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
BeOne Medicines has 1 study filed under Chronic Urticaria — fewer than ten, so there is no comparison to draw.
10 of the studies in Chronic Urticaria with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07402213Phase 3JemincareTrial of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria. | 2027-06-07 |
| NCT06604949Longbio PharmaA Study of Single Dose of LP-003 in Healthy Adult Subjects | 2026-11 |
| NCT07005713BeOne MedicinesA 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 | 2026-11-30 |
| NCT07613866Chengdu Suncadia Medicine Co., Ltd.A Clinical Trial of HRS-3095 in Patients With Chronic Spontaneous Urticaria | 2026-12 |
| NCT07219615PfizerA Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults. | 2026-12-25 |
Add all 10 to your calendar (.ics) → With an account.
Among the 34 studies in Chronic Urticaria with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Part A
Part B
Exclusion Criteria:
Part A
All Participants
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sequential cohorts of increasing dose levels of tacabrutideg will be evaluated in participants with CSU.
Drug: Tacabrutideg
Participants with CSU will receive matching placebo orally for 28 days and then crossover to receive tacabrutideg.
Drug: Tacabrutideg · Drug: Placebo
Sequential cohorts of increasing dose levels of tacabrutideg will be evaluated in healthy participants.
Drug: Tacabrutideg
Administered orally
Also known as: BGB-16673
Administered orally
Part A: Number of participants with adverse events (AEs)
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including findings from laboratory tests and electrocardiogram results.
Time frame: Up to approximately 4 months
Part B: Number of participants with adverse events (AEs)
Number of participants with TEAEs and SAEs, including findings from laboratory tests and electrocardiogram results.
Time frame: Up to approximately 6 weeks
Part A: Maximum observed plasma concentration (Cmax) of tacabrutideg
Time frame: Up to approximately 10 weeks
Part A: Minimum observed plasma concentration (Cmin) of tacabrutideg
Time frame: Up to approximately 10 weeks
Part A: Time to reach maximum observed plasma concentration (Tmax) of tacabrutideg
Time frame: Up to approximately 10 weeks
Part A: Apparent terminal elimination half life (t1/2) of tacabrutideg
Time frame: Up to approximately 10 weeks
Part A: Area under the curve (AUC) of tacabrutideg
Time frame: Up to approximately 10 weeks
Part A: Apparent oral clearance (CL/F) of tacabrutideg
Time frame: Up to approximately 10 weeks
Part A: Apparent volume of distribution (Vz/F) of tacabrutideg
Time frame: Up to approximately 10 weeks
Part A: Accumulation Ratio of AUC for tacabrutideg
Time frame: Up to approximately 10 weeks
Part A: Accumulation Ratio of Cmax for tacabrutideg
Time frame: Up to approximately 10 weeks
Part A: Change from Baseline in Weekly Urticaria Activity Score (UAS7)
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.
Time frame: Baseline and up to approximately 3 months
Part A: Change from baseline in weekly Itch Severity Score (ISS7)
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.
Time frame: Baseline and up to approximately 3 months
Part A: Change from baseline in weekly Hives Severity Score (HSS7)
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.
Time frame: Baseline and up to approximately 3 months
Part A: Change from baseline in weekly Angioedema Activity Score (AAS7)
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.
Time frame: Baseline and up to approximately 3 months
Part A: Change from baseline in 7-day recall period version of the Urticaria Control Test (UCT7)
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.
Time frame: Baseline and up to approximately 3 months
Part A: Percentage of participants with complete absence of hives and itch, assessed as UAS7 = 0
Time frame: Up to approximately 3 months
Part A: Percentage of participants with UAS7 ≤ 6 response
Time frame: Up to approximately 3 months
Part A: Levels of Bruton tyrosine kinase (BTK) protein
Time frame: Up to approximately 3 months
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Plan to share: Yes — BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See plan description
Access criteria: See plan description
Data sharing details ↗ · beonemedicines.com
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Nov 2026, 16 months after the start.
Of 15 phase 1 interventional studies under Chronic Urticaria, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 21. This study's planned 16 months is close to that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Tacabrutideg