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NOVARTIS (RECLAIM) AGE Greater than 18 YEARS AND OLDER (CSU STUDY)
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NOVARTIS (RECLAIM) AGE Greater than 18 YEARS AND OLDER (CSU STUDY)
- The purpose of the study is to evaluate the efficacy of remibrutinib when compared to dupilumab at early timepoints in adults with chronic spontaneous urticaria inadequately controlled by second generation H1-antihistamines.
- Remibrutinib is a low molecular weight compound for oral administration that covalently binds and inhibits BTK (Bruton’s tyrosine kinase (BTK).
- Dupilumab is a fully human monoclonal antibody directed against the shared IL-4 receptor subunit α of IL-4 and IL-13 receptors.
- Duration: 24 weeks.
Key Inclusion
- CSU duration for ≥ 6 months prior to screening
- Documentation of hives within three months before randomization
- Male and female adult participants ≥ 18 years of age
- History of > 1 exacerbation(s) in the previous year before V1.
Key Exclusion:
- Previous use of dupilumab (Dupixent).
- Sole trigger of their chronic urticaria (i.e., chronic inducible urticaria), including symptomatic dermographism.
- 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.
Explore More About These Research Trials
An easy way to track when your study milestones, treatments, or updates are expected.
Interested in hearing more about these Research Trials?
Please contact one of our staff at 502.368.0732 or fill out the form below: