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.
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
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.
Sequential
Tacabrutideg
DrugAdministered orally
Placebo
DrugAdministered orally
Part A: 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.
Part B: Number of participants with adverse events (AEs)
Number of participants with TEAEs and SAEs, including findings from laboratory tests and electrocardiogram results.
Part A: Maximum observed plasma concentration (Cmax) of tacabrutideg
Part A: Minimum observed plasma concentration (Cmin) of tacabrutideg
Part A: Change from Baseline in Weekly Urticaria Activity Score (UAS7)
The UAS7 consists of an assessment of both hives and itch severity to provide a measure of disease activity. The UAS7 is the sum of the weekly Hives Severity Score (HSS7) and the weekly Itch Severity Score (ISS7) and ranges between 0 and 42. A UAS7 score of 0 signifies that the patient is symptom free, and high UAS7 scores indicate severe symptoms.
Part A: Change from baseline in weekly Itch Severity Score (ISS7)
The Itch Severity Score (ISS) is a measure of itching. Daily scores range from 0 (no itching) to 3 (intense itching). The ISS7 is a weekly score derived by adding up the daily ISS scores of the past 7 days and ranges from 0 to 21.
Part A: Change from baseline in weekly Hives Severity Score (HSS7)
The Hives Severity Score (HSS) is a measure of the number of hives present recorded by the participant. Daily scores range from 0 (no hives) to 3 (intense/severe hives). HSS7 is the sum of the daily HSS scores over the past 7 days and ranges from 0 to 21.
Part A: Change from baseline in weekly Angioedema Activity Score (AAS7)
The Angioedema Activity Score (AAS) is a validated tool designed and verified to measure disease activity, assess response to treatment, and optimize the treatment plan for patients with recurrent angioedema. Responses are filled out prospectively and daily, evaluating five main factors related to angioedema: duration, physical discomfort caused, impact on daily activities, effect on appearance, and overall severity, each scored between 0 and 3. Daily AAS scores can range daily from 0 to 15, and weekly (AAS7) from 0 to 105. Higher AAS scores indicate frequent and severe attacks. Lower scores indicate well-controlled symptoms.
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