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Chronic Spontaneous UrticariaPhase 1NCT07005713

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

A Phase 1 study testing Tacabrutideg in people with Chronic Spontaneous Urticaria, run by BeOne Medicines at 9 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Spontaneous Urticaria
What is being tested?
Tacabrutideg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
58 participants
Where
9 sitesChina
Study dates
19 Jul 2025to 30 Nov 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Part A
  • 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
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  • 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).

Who cannot join

  • Part A
  • 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.
  • All Participants
  • Any uncontrolled disease state, including asthma or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids.
Show all 9Show fewer
  • Significant bleeding risk or coagulopathy.
  • Prior exposure to any BTK inhibitors or protein degraders.
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Study Director contact

1-877-828-5568

clinicaltrials@beonemed.com

9 sites in 1 country

China9 sites, 1 recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100000

    Completed

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

    Completed

  • Chengdu Second Peoples Hospital

    Chengdu, Sichuan, 610021

    Completed

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 630014

    Completed

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong

    Completed

  • Hangzhou First Peoples Hospital

    Hangzhou, Zhejiang, 310006

    Completed

  • The Affiliated Hospital of Qingdao University Branch West Coast

    Qingdao, Shandong, 266555

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Completed

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

    Completed

Other trials in China

About this study

Official title: A Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple- Ascending Doses of BGB-16673 in Patients With Chronic Spontaneous Urticaria and in Healthy Participants

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.

Being tested
Tacabrutideg, Placebo
Medical subject headings
Chronic Urticaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TacabrutidegDrug

    Also called BGB-16673

    Administered orally

  • PlaceboDrug

    Administered orally

Study groups in NCT07005713
Study groupRoleWhat they receive
Part A (CSU): TacabrutidegExperimentalSequential cohorts of increasing dose levels of tacabrutideg will be evaluated in participants with CSU.
Receives: Drug: Tacabrutideg
Part A (CSU): PlaceboPlacebo comparatorParticipants with CSU will receive matching placebo orally for 28 days and then crossover to receive tacabrutideg.
Receives: Drug: Tacabrutideg; Drug: Placebo
Part B (Healthy Participants): TacabrutidegExperimentalSequential cohorts of increasing dose levels of tacabrutideg will be evaluated in healthy participants.
Receives: Drug: Tacabrutideg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to approximately 4 months

  2. Part B: Number of participants with adverse events (AEs)

    Number of participants with TEAEs and SAEs, including findings from laboratory tests and electrocardiogram results.

    Measured: Up to approximately 6 weeks

  3. Part A: Maximum observed plasma concentration (Cmax) of tacabrutideg

    Measured: Up to approximately 10 weeks

  4. Part A: Minimum observed plasma concentration (Cmin) of tacabrutideg

    Measured: Up to approximately 10 weeks

  5. Part A: Time to reach maximum observed plasma concentration (Tmax) of tacabrutideg

    Measured: Up to approximately 10 weeks

  6. Part A: Apparent terminal elimination half life (t1/2) of tacabrutideg

    Measured: Up to approximately 10 weeks

  7. Part A: Area under the curve (AUC) of tacabrutideg

    Measured: Up to approximately 10 weeks

  8. Part A: Apparent oral clearance (CL/F) of tacabrutideg

    Measured: Up to approximately 10 weeks

  9. Part A: Apparent volume of distribution (Vz/F) of tacabrutideg

    Measured: Up to approximately 10 weeks

  10. Part A: Accumulation Ratio of AUC for tacabrutideg

    Measured: Up to approximately 10 weeks

  11. Part A: Accumulation Ratio of Cmax for tacabrutideg

    Measured: Up to approximately 10 weeks

Secondary outcomes (8)

  1. 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.

    Measured: Baseline and up to approximately 3 months

  2. 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.

    Measured: Baseline and up to approximately 3 months

  3. 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.

    Measured: Baseline and up to approximately 3 months

  4. 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.

    Measured: Baseline and up to approximately 3 months

  5. 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.

    Measured: Baseline and up to approximately 3 months

  6. Part A: Percentage of participants with complete absence of hives and itch, assessed as UAS7 = 0

    Measured: Up to approximately 3 months

  7. Part A: Percentage of participants with UAS7 ≤ 6 response

    Measured: Up to approximately 3 months

  8. Part A: Levels of Bruton tyrosine kinase (BTK) protein

    Measured: Up to approximately 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2025
  2. Study start19 Jul 2025
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Part A is a double-blinded, placebo-controlled study to evaluate tacabrutideg in adults with moderate to severe CSU. Part B is an open-label study of tacabrutideg in healthy participants.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07005713
Sponsor's protocol ID
BGB-16673-107
Status last verified
Sep 2026
First submitted
22 May 2025
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tacabrutideg in people with Chronic Spontaneous Urticaria, run by BeOne Medicines at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Director (1-877-828-5568, clinicaltrials@beonemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Number of participants with adverse events (AEs) (time frame: Up to approximately 4 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07005713.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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