A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of BGB-16673 in Adults With Chronic Spontaneous Urticaria

Last updated: June 17, 2026
Sponsor: BeiGene
Overall Status: Completed

Phase

1

Condition

Hives (Urticaria)

Urticaria

Treatment

Placebo

BGB-16673

Clinical Study ID

NCT07005713
BGB-16673-107
  • Ages 18-70
  • All Genders

Study Summary

This study is a Phase 1b, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of multiple-ascending doses of BGB-16673 in adults with chronic spontaneous urticaria (CSU).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must be diagnosed with chronic spontaneous urticaria (CSU) for ≥ 6months before randomization.

  • The presence of itch and hives for ≥6 consecutive weeks at any time prior torandomization 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 7days before randomization

  • Presence of hives must have been documented within 3 months before randomization

Exclusion

Exclusion Criteria:

  • Participants who have a clearly defined, predominating or sole trigger for theirchronic 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 theinvestigators opinion the study evaluations and results, eg, atopic dermatitis,bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or psoriasis.

  • Any uncontrolled disease state, including asthma or inflammatory bowel disease whereflares 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.

Study Design

Total Participants: 34
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
July 19, 2025
Estimated Completion Date:
April 16, 2026

Connect with a study center

  • Peking University Third Hospital

    Beijing, Beijing Municipality 100000
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality 630014
    China

    Site Not Available

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong
    China

    Site Not Available

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • Dermatology Hospital of Southern Medical University

    Guangzhou 1809858, Guangdong 1809935
    China

    Site Not Available

  • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)

    Guangzhou 1809858, Guangdong 1809935 510000
    China

    Site Not Available

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei 430022
    China

    Site Not Available

  • Xiangya Hospital of Central South University

    Changsha, Hunan 410008
    China

    Site Not Available

  • Chengdu Second Peoples Hospital

    Chengdu, Sichuan 610021
    China

    Site Not Available

  • Hangzhou First Peoples Hospital

    Hangzhou, Zhejiang 310006
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

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