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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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