* CDFV890A12201
Research type
Research Study
Full title
An open-label, single arm phase II study of DFV890 to assess the safety, tolerability and efficacy in participants with familial cold auto-inflammatory syndrome (FCAS)
IRAS ID
1004436
Contact name
Claus-Peter Danzer
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2020-005948-33
Clinicaltrials.gov Identifier
Research summary
The purpose of the study is to assess if treatment with DFV890 is safe and effective in the treatment of people with your health condition, Familial Cold Autoinflammatory Syndrome (FCAS). DFV890 has already been examined in one study in patients with COVID-19 (approximately 60 patients) . The safety and effectiveness of DFV890 has not been established in people with FCAS. The study includes a screening, a treatment period and a follow-up period and at most, the study will last approximately four months. Blood samples will be collected to measure the level of the study drug in your system as well as other disease markers or signals. This may potentially help understand how the body responds to the study drug, and allow for a better understanding about the disease. Six patients will join this study in several countries. \n1-2 people with FCAS aged 18 to 80 years inclusive are being invited to join this study in the United Kingdom. The pharmaceutical company named Novartis sponsors this study.
REC name
London - City & East Research Ethics Committee
REC reference
22/FT/0060
Date of REC Opinion
13 Jun 2022
REC opinion
Further Information Favourable Opinion