Managed Access Program (Map) Cohort Treatment Plan Clou064a2002m To Provide Access To Remibrutinib For Adult Patients With Chronic Spontaneous Urticaria (Csu)
Posted Date: Jan 27, 2025
- Investigator: Yashu Dhamija
- Specialties: Allergy, Immunology
- Type of Study: Drug
CSU is an unpredictable and severe disease of the skin, affecting 0.5-1% of the global population at any time (1). It is characterized by the development of itchy, painful wheals (hives), swelling (angioedema), or both, lasting for at least 6 weeks and occurring with no known cause (2). CSU can be challenging or frustrating for patients due to the severity and unpredictable nature (3). Available evidence indicates that all forms of chronic urticaria can substantially affect patients’ quality of life (QoL), ability to perform daily tasks, and mental health. Patients with chronic urticaria experience substantial health-related quality of life (HRQoL) and productivity impairments and increased psychological comorbidities relative to patients without chronic urticaria (4). Results from a phase 2 study in subjects with moderate to severe CSU, demonstrated clinically meaningful reductions in UAS7 score in subjects treated with remibrutinib. The remibrutinib 25 mg b.i.d. dose was considered the optimal dose based on the efficacy data and the fact that remibrutinib was safe and well tolerated with no dose dependent safety signal in the study. The purpose of this Managed Access Program (MAP) Cohort Treatment Plan is to provide guidance to the Physician for the treatment and monitoring of patients in the Cohort MAP. The Physician should follow the suggested treatment guidelines. Furthermore, the Physician must comply with the MAP Agreement Letter and applicable local laws and regulations. Prior to inclusion of a patient in the Cohort, the requesting Physician must submit a request for access to the product in GEMS (Grants, External Requests and Managed Access System) accessible through https://www.novartis.com/our-focus/healthcare-professionals/managed-access-programs providing the rationale for the request and relevant medical history of the patient. The request is then assessed against the MAP and Cohort inclusion/exclusion criteria by the medical team experienced with the product and indication. Upon the required approvals, the patient is included in the Cohort.
Criteria:
Patients Eligible For Inclusion In This Treatment Plan Have To Meet All Of The Following Criteria: 1. Adult Male And Female Subjects (= 18 Years) Who Are Able And Willing To Provide Written Informed Consent Prior To Enrolling In The Cohort. 2. Csu Diagnosis For = 6 Months (Defined As Onset Of Csu With Supporting Documentation). 3. Diagnosis Of Csu Refractory To H1-Ah At Locally Label Approved Doses And To Omalizumab (Where Applicable), As Assessed By The Treating Physician, Using One Of The Following Tools: Uas7, Uct Or Dlqi 4. Not Eligible Or Able To Enroll In A Clinical Trial Or No Relevant Clinical Trials Available
Keywords:
Hives, Remibrutinib
For More Information:
Yashu Dhamija
5138880664
dhamijyu@ucmail.kuc.edu