Sponsor Decision

The study duration for an individual subject includes screening (14 days), the treatment period (28 days) and the observational follow-up period of 28 days, in total 70 days ± 6 days. All subjects will receive IMP for 28 days followed by one End of Study (EOS) visit, 4 weeks after EOT visit.

Inclusion Criteria:

• Signed informed consent.
• Subjects must be 18 years or older at the time of signing the informed consent.

Exclusion Criteria:

• Subjects with known severe or life-threatening hypersensitivity reaction to any other CSU/HS treatment according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE).

• Subjects who have any other skin disease that may interfere with assessment of CSU or HS.

• Subjects who have an active infection or history of infection(s) as follows:

  1. Any infection requiring systemic treatment within 14 days prior to baseline.
  2. A history of opportunistic, recurrent, or chronic infections that, in the opinion of the Investigator, might cause this study to be detrimental to the subject.

• Subjects with known progressed liver disease (Child-Pugh B or C)