Clinical trial NCT07005713: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of BGB-16673 in Adults With Chronic Spontaneous Urticaria
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Chronic Spontaneous Urticaria
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2025-06-05
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to approximately 4 months
measure: Maximum observed plasma concentration (Cmax) of BGB-16673
timeFrame: Up to approximately 10 weeks
measure: Minimum observed plasma concentration (Cmin) of BGB-16673
timeFrame: Up to approximately 10 weeks
measure: Time to reach maximum observed plasma concentration (Tmax) of BGB-16673
timeFrame: Up to approximately 10 weeks
measure: Apparent terminal elimination half life (t1/2) of BGB-16673
timeFrame: Up to approximately 10 weeks
measure: Area under the curve (AUC) of BGB-16673
timeFrame: Up to approximately 10 weeks
measure: Apparent oral clearance (CL/F) of BGB-16673
timeFrame: Up to approximately 10 weeks
measure: Apparent volume of distribution (Vz/F) of BGB-16673
timeFrame: Up to approximately 10 weeks
measure: Accumulation Ratio of AUC for BGB-16673
timeFrame: Up to approximately 10 weeks
measure: Accumulation Ratio of Cmax for BGB-16673
timeFrame: Up to approximately 10 weeks
Secondary outcomes:
measure: Change from Baseline in Weekly Urticaria Activity Score (UAS7)
timeFrame: Baseline and up to approximately 3 months
measure: Change from baseline in weekly Itch Severity Score (ISS7)
timeFrame: Baseline and up to approximately 3 months
measure: Change from baseline in weekly Hives Severity Score (HSS7)
timeFrame: Baseline and up to approximately 3 months
measure: Change from baseline in weekly Angioedema Activity Score (AAS7)
timeFrame: Baseline and up to approximately 3 months
measure: Change from baseline in 7-day recall period version of the Urticaria Control Test (UCT7)
timeFrame: Baseline and up to approximately 3 months
measure: Percentage of participants with complete absence of hives and itch, assessed as UAS7 = 0
timeFrame: Up to approximately 3 months
measure: Percentage of participants with UAS7 ≤ 6 response
timeFrame: Up to approximately 3 months
measure: Levels of Bruton tyrosine kinase (BTK) protein
timeFrame: Up to approximately 3 months
Other outcomes:
Locations:
Study officials:
affiliation: BeiGene
name: Study Director
role: STUDY_DIRECTOR
References: