Study of Safety, Tolerability and Efficacy of DFV890 in Participants With Familial Cold Auto-inflammatory Syndrome (FCAS)

Completed · Phase 2

Conditions studied: Familial Cold Autoinflammatory Syndrome

In brief

The purpose of this phase II study was to assess the safety, tolerability and efficacy of DFV890 in participants with FCAS.

Key facts

Study ID

NCT04868968

Run by

Novartis Pharmaceuticals

People needed

4

Starts

2021-09-20

Expected to finish

2023-05-05

Last updated by the study team

2024-10-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — La Jolla, California, United States
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Tübingen, Germany

Full record on ClinicalTrials.gov

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