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Taking peoplePhase 1

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

Key facts

Who runs it
BeOne Medicines
Where
China9 sites in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
Phase
Phase 1
People taking part
58 people, planned
Started
19 Jul 2025
Expected to end
30 Nov 2026
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Tacabrutideg
  • Placebo
Record updated
9 September 2026

Who can take part

Age
18 years to 70 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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)

Who cannot take part

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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 70 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Part A (CSU): TacabrutidegTreatment being tested

    Sequential cohorts of increasing dose levels of tacabrutideg will be evaluated in participants with CSU.

    Treatment: Tacabrutideg

  • Part A (CSU): PlaceboPlacebo, for comparison

    Participants with CSU will receive matching placebo orally for 28 days and then crossover to receive tacabrutideg.

    Treatment: Tacabrutideg and Placebo

  • Part B (Healthy Participants): TacabrutidegTreatment being tested

    Sequential cohorts of increasing dose levels of tacabrutideg will be evaluated in healthy participants.

    Treatment: Tacabrutideg

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Fit questions
Built from NCT07005713, who can take part
Record updated
9 September 2026