Status:
COMPLETED
Study of Safety, Tolerability and Efficacy of DFV890 in Participants With Familial Cold Auto-inflammatory Syndrome (FCAS)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Familial Cold Autoinflammatory Syndrome
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this phase II study was to assess the safety, tolerability and efficacy of DFV890 in participants with FCAS.
Detailed Description
This was an open-label, single-arm, multiple dose, phase II study to assess safety, tolerability and clinical efficacy of DFV890 in participants with FCAS who showed evidence of inflammatory activity ...
Eligibility Criteria
Inclusion
- Written informed consent must be obtained before any study-specific assessment is performed
- Body mass index within the range of 18-35 kg/m2
- Patients with a genetic diagnosis of FCAS
- Patients with a clinical history and investigations consistent with FCAS
Exclusion
- Anti-rejection and/or immunomodulatory drugs must be discontinued (please, see protocol for further details)
- Clinically significant, suspected active or chronic bacterial (including Mycobacterium tuberculosis), viral or fungal infection within 30 days prior to Day 1.
- Patients with innate (e.g. TLR immunodeficiencies, defects in IFN-γ signaling) or acquired immune deficiencies (e.g. AIDS).
- Presence of human immunodeficiency virus (HIV) infection, hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti-HBc), or hepatitis C antibodies at screening.
- Live vaccines within 4 weeks of Day 1
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential unless they are using highly effective methods of contraception.
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
September 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2023
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04868968
Start Date
September 20 2021
End Date
May 5 2023
Last Update
October 9 2024
Active Locations (3)
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1
Novartis Investigative Site
La Jolla, California, United States, 92093
2
Novartis Investigative Site
Paris, France, 75970
3
Novartis Investigative Site
Tübingen, Germany, 72076