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

ACTIVE_NOT_RECRUITINGPHASE1

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

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple- Ascending Doses of BGB-16673 in Patients With Chronic Spontaneous Urticaria

NCT07005713•BeiGene

View on ClinicalTrials.gov

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

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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.
•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.

Locations (8)

Peking University Third Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China

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

Wuhan, Hubei, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

Chengdu Second Peoples Hospital

Chengdu, Sichuan, China

Hangzhou First Peoples Hospital

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Key Dates

Start Date

July 19, 2025

Primary Completion Date

April 17, 2026

Completion Date

April 17, 2026

Last Updated

February 3, 2026

Enrollment

ACTUAL participants

Conditions

Chronic Spontaneous Urticaria

Interventions

BGB-16673

DRUG

Placebo

DRUG

Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)

NCT06931405

Chronic Inducible UrticariaChronic Spontaneous Urticaria

View study

RECRUITINGPHASE2

Phase 2b Study of EVO756 in Adults With Moderate to Severe Chronic Spontaneous Urticaria (CSU)

NCT06873516

Chronic Spontaneous Urticaria

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)

Phase 2b Study of EVO756 in Adults With Moderate to Severe Chronic Spontaneous Urticaria (CSU)

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A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria