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

BeOne Medicines

Status and phase: Enrolling; Phase 1

Conditions: Chronic Spontaneous Urticaria

Treatments: Drug: Tacabrutideg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07005713

BGB-16673-107

Details and patient eligibility

About

This is a Phase 1b study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of multiple-ascending doses of tacabrutideg in adults with chronic spontaneous urticaria (CSU) and in healthy participants.

Enrollment: 58 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Part A

• 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

Part B

• Participants must be 18 to 55 years of age and healthy, with no clinically relevant abnormalities.
• Body Mass Index (BMI) of 18 to 32 kg/m^2; and a total body weight > 50 kg (110 lbs).

Exclusion criteria

Part A

• 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.

All Participants

• 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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58 participants in 3 patient groups, including a placebo group

Part A (CSU): Tacabrutideg

Experimental group

Description:

Sequential cohorts of increasing dose levels of tacabrutideg will be evaluated in participants with CSU.

Treatment:

Drug: Tacabrutideg

Part A (CSU): Placebo

Placebo Comparator group

Description:

Participants with CSU will receive matching placebo orally for 28 days and then crossover to receive tacabrutideg.

Treatment:

Drug: Placebo

Drug: Tacabrutideg

Part B (Healthy Participants): Tacabrutideg

Experimental group

Description:

Sequential cohorts of increasing dose levels of tacabrutideg will be evaluated in healthy participants.

Treatment:

Drug: Tacabrutideg