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

BeiGene

Status and phase: Active, not recruiting; Phase 1

Conditions: Chronic Spontaneous Urticaria

Treatments: Drug: Placebo; Drug: BGB-16673

Study type: Interventional

Funder types: Industry

Identifiers

NCT07005713

BGB-16673-107

Details and patient eligibility

About

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).

Enrollment: 34 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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34 participants in 2 patient groups, including a placebo group

BGB-16673

Experimental group

Description:

Participants will receive BGB-16673 orally

Treatment:

Drug: BGB-16673

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: BGB-16673

Drug: Placebo