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NCT Number: NCT07005713

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

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.

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Key information

Conditions

Chronic Spontaneous Urticaria Chronic Disease Chronic Urticaria Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University Third Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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 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.
  • Significant bleeding risk or coagulopathy.
  • Prior exposure to any BTK inhibitors or protein degraders.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

Tacabrutideg

Drug

Administered orally

Other names: BGB-16673

Placebo

Drug

Administered orally

Primary outcomes

  1. Part A: Number of participants with adverse events (AEs)

    Time frame: 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.

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

    Time frame: Up to approximately 6 weeks

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

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

    Time frame: Up to approximately 10 weeks

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

    Time frame: Up to approximately 10 weeks

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

    Time frame: Up to approximately 10 weeks

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

    Time frame: Up to approximately 10 weeks

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

    Time frame: Up to approximately 10 weeks

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

    Time frame: Up to approximately 10 weeks

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

    Time frame: Up to approximately 10 weeks

  10. Part A: Accumulation Ratio of AUC for tacabrutideg

    Time frame: Up to approximately 10 weeks

  11. Part A: Accumulation Ratio of Cmax for tacabrutideg

    Time frame: Up to approximately 10 weeks

Secondary outcomes

  1. Part A: Change from Baseline in Weekly Urticaria Activity Score (UAS7)

    Time frame: 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.

  2. Part A: Change from baseline in weekly Itch Severity Score (ISS7)

    Time frame: 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.

  3. Part A: Change from baseline in weekly Hives Severity Score (HSS7)

    Time frame: 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.

  4. Part A: Change from baseline in weekly Angioedema Activity Score (AAS7)

    Time frame: 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.

  5. Part A: Change from baseline in 7-day recall period version of the Urticaria Control Test (UCT7)

    Time frame: 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.

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

    Time frame: Up to approximately 3 months

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

    Time frame: Up to approximately 3 months

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

    Time frame: Up to approximately 3 months

Interested in participating?

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Sponsors and collaborators

Lead sponsor

BeOne Medicines

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2025
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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