Ensayos clínicos

Inclusion Criteria:

- Signed informed consent must be obtained prior to participation in the study.

- Male and female adult participants ≥18 years of age at the time of screening.

- CSU duration for ≥ 6 months prior to screening (defined as the onset of CSU determined
by the investigator based on all available supporting documentation).

- Diagnosis of CSU inadequately controlled by second generation H1-antihistamines at the
time of randomization defined as:

- The presence of itch and hives for ≥6 consecutive weeks prior to screening despite the
use of second generation H1-antihistamines during this time period

- UAS7 score (range 0-42) ≥16, ISS7 score (range 0-21) ≥ 6 and HSS7 score (range 0-21) ≥
6 during the 7 days prior to randomization (Day 1)

- Documentation of hives within three months before randomization (either at screening
and/or at randomization; or documented in the participants medical history).

- Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration
of the study and adhere to the study protocol.

- Participants must not have had more than one missing UPDD entry (either morning or
evening) in the 7 days prior to randomization (Day 1).

Exclusion Criteria:

- Participants having a clearly defined predominant or sole trigger of their chronic
urticaria (CU) (chronic inducible urticaria (CINDU)) including urticaria factitia
(symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-,
aquagenic-, cholinergic-, or contact-urticaria

- Other diseases with symptoms of urticaria or angioedema, including but not limited to
urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis,
hereditary urticaria, or drug-induced urticaria

- Any other skin disease associated with chronic itching that might influence in the
investigator's opinion the study evaluations and results, e.g. atopic dermatitis,
bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis

- Evidence of clinically significant cardiovascular (such as but not limited to
myocardial infarction, unstable ischemic heart disease, New York heart association
(NYHA) Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension
within 12 months prior to Visit 1), neurological, psychiatric, pulmonary, renal,
hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or
immunodeficiency that, in the investigator's opinion, would compromise the safety of
the participant, interfere with the interpretation of the study results or otherwise
preclude participation or protocol adherence of the participant

- Significant bleeding risk or coagulation disorders

- History of gastrointestinal bleeding, e.g. in association with use of nonsteroidal
anti-inflammatory drugs (NSAID), that was clinically relevant (e.g. requiring
hospitalization or blood transfusion)

- Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100
mg/d or clopidogrel. The use of dual anti-platelet therapy (e.g. acetylsalicylic acid
+ clopidogrel) is prohibited.

- Requirement for anticoagulant medication (for example, warfarin or Novel Oral
Anti-Coagulants (NOAC))

- History or current hepatic disease including but not limited to acute or chronic
hepatitis, cirrhosis or hepatic failure or Aspartate Aminotransferase (AST)/ Alanine
Aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) or
International Normalized Ratio (INR) of more than 1.5 at screening

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

Eligibility last updated 9/15/22. Questions regarding updates should be directed to the study team contact.