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

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)

ClinicalTrials.gov Identifier: NCT04868968

Novartis Reference Number: CDFV890A12201

Last Update: May 16, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This is an open-label, single-arm, multiple dose, phase II study to assess safety, tolerability and clinical efficacy of DFV890 in participants with FCAS.

The study includes a screening period, a treatment period and a follow-up period. At most, the study will last approximately 4 months.

Condition 
Familial Cold Autoinflammatory Syndrome
Phase 
Phase 2
Overall status 
Recruiting
Start date 
Sep 20, 2021
Completion date 
Aug 18, 2022
Gender 
All
Age(s)
18 Years - 80 Years (Adult, Older Adult)

Interventions

Drug
DFV890
DFV890

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

Participants currently being treated with anti-rejection and/or immunomodulatory drugs and the treatment cannot be discontinued or switched to a different medication
Clinically significant, suspected active or chronic bacterial (including Mycobacterium tuberculosis), viral or fungal infection within 30 days prior to dosing.
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 dosing
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

Study Locations

United States
Novartis Investigative Site
Recruiting
La Jolla, 92093
California
United States
France
Novartis Investigative Site
Recruiting
Paris, 75020
-
France
Germany
Novartis Investigative Site
Recruiting
Tübingen, 72076
-
Germany

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]