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Novartis (RECLAIM) Chronic Spontaneous Urticaria (CSU) Study
If you are interested in participating and believe you meet the requirements, please contact our research staff to learn more at 502.368.0732.
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- Novartis (RECLAIM) Chronic Spontaneous Urticaria (CSU) Study
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 Criteria:
- 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 Criteria:
- 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.
Interested in This Research Study?
If you’d like to learn more or see whether you may be eligible to participate, please complete the brief interest form below. A member of our research team will follow up with next steps.
Research Study Interest Form
To learn more or express interest in this study, please complete the form below or contact our research team at 502-368-0732.