Tacabrutideg (BGB-16673) for Chronic Spontaneous Urticaria: Safety and PK in Adults and Healthy Volunteers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1b study to examine the safety, tolerability, pharmacokinetics, and pharmacodynamics of escalating doses of tacabrutideg in adults with chronic spontaneous urticaria and in healthy participants. The trial compares tacabrutideg with placebo to understand dose-related effects. Key eligibility requires CSU patients with persistent symptoms despite second-generation antihistamines, and healthy adults meeting basic health and BMI criteria. Sites are in China, at three university-affiliated hospitals. The study aims to characterize how the drug behaves in the body and how it affects disease-related biology at different dose levels.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Affiliated Hospital of Qingdao University Branch West Coast
  Qingdao, Shandong, China Recruiting
• Peking University Third Hospital
  Beijing, Beijing Municipality, China Completed
• The First Affiliated Hospital of Chongqing Medical University
  Chongqing, Chongqing Municipality, China Completed
• Dermatology Hospital of Southern Medical University
  Guangzhou, Guangdong, China Completed
• Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Completed
• Xiangya Hospital of Central South University
  Changsha, Hunan, China Completed

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@beonemed.com
• Phone: 1-877-828-5568

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• JYB1904 Injection for Chronic Spontaneous Urticaria in Adults

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.