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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

RecruitingPhase 1Ages 18 Years - 70 YearsAllBeOne Medicines
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Part A * Participants must be diagnosed with chronic spontaneous urticaria (CSU) for โ‰ฅ 6 months before randomization. * The presence of itch and hives for โ‰ฅ6 consecutive weeks at any time prior to randomization despite the use of second-generation H1-antihistamines * UAS7โ‰ฅ16 and HSS7โ‰ฅ8 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.
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What it tests

  • Tacabrutideg
  • Placebo
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Where

9 sites
Peking University Third Hospital
Beijing, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Dermatology Hospital of Southern Medical University
Guangzhou, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Xiangya Hospital of Central South University
Changsha, China
The Affiliated Hospital of Qingdao University Branch West Coast
Qingdao, China
Chengdu Second Peoples Hospital
Chengdu, China
Hangzhou First Peoples Hospital
Hangzhou, China

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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