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

NCT07005713 | Active Not Recruiting Phase 1

• 1 other identifier: BGB-16673-107
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 8

Brief 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).

Conditions

Chronic Spontaneous Urticaria

Outcome Measures

Primary Outcomes (10)

• Number of participants with adverse events (AEs)

  Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including findings from laboratory tests and electrocardiogram results.

  Up to approximately 4 months

• Maximum observed plasma concentration (Cmax) of BGB-16673

  Up to approximately 10 weeks

• Minimum observed plasma concentration (Cmin) of BGB-16673

  Up to approximately 10 weeks

• Time to reach maximum observed plasma concentration (Tmax) of BGB-16673

  Up to approximately 10 weeks

• Apparent terminal elimination half life (t1/2) of BGB-16673

  Up to approximately 10 weeks

• Area under the curve (AUC) of BGB-16673

  Up to approximately 10 weeks

• Apparent oral clearance (CL/F) of BGB-16673

  Up to approximately 10 weeks

• Apparent volume of distribution (Vz/F) of BGB-16673

  Up to approximately 10 weeks

• Accumulation Ratio of AUC for BGB-16673

  Up to approximately 10 weeks

• Accumulation Ratio of Cmax for BGB-16673

  Up to approximately 10 weeks

Secondary Outcomes (8)

• Change from Baseline in Weekly Urticaria Activity Score (UAS7)

  Baseline and up to approximately 3 months

• Change from baseline in weekly Itch Severity Score (ISS7)

  Baseline and up to approximately 3 months

• Change from baseline in weekly Hives Severity Score (HSS7)

  Baseline and up to approximately 3 months

• Change from baseline in weekly Angioedema Activity Score (AAS7)

  Baseline and up to approximately 3 months

• Change from baseline in 7-day recall period version of the Urticaria Control Test (UCT7)

  Baseline and up to approximately 3 months

Study Arms (2)

BGB-16673

EXPERIMENTAL

Participants will receive BGB-16673 orally

Drug: BGB-16673

Placebo

PLACEBO COMPARATOR

Participants will receive placebo orally for 28 days and then crossover to receive BGB-16673.

Drug: BGB-16673; Drug: Placebo

Interventions

BGB-16673 DRUG

Administered orally

BGB-16673; Placebo

Placebo DRUG

Administered orally

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• BeiGene: lead

Study Sites (8)

Peking University Third Hospital

Beijing, Beijing Municipality, 100000, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 630014, China

Location

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

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

Wuhan, Hubei, 430022, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location

Chengdu Second Peoples Hospital

Chengdu, Sichuan, 610021, China

Location

Hangzhou First Peoples Hospital

Hangzhou, Zhejiang, 310006, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Study Director

  BeiGene

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 5, 2025
• Study Start: July 19, 2025
• Primary Completion: April 17, 2026
• Study Completion: April 17, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

CN (8)