Study of Safety, Tolerability and Efficacy of DFV890 in Participants With Familial Cold Auto-infl… (NCT04868968) | Clinical Trial Compass
CompletedPhase 2
Study of Safety, Tolerability and Efficacy of DFV890 in Participants With Familial Cold Auto-inflammatory Syndrome (FCAS)
United States, France, Germany4 participantsStarted 2021-09-20
Plain-language summary
The purpose of this phase II study was to assess the safety, tolerability and efficacy of DFV890 in participants with FCAS.
Who can participate
Age range18 Years – 80 Years
SexALL
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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:
* 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.
What they're measuring
1
Ratio of Fold Change From Pre-challenge to the Highest Post-challenge Value of White Cell Count (WCC) Between Treatment and Screening Period
Timeframe: Screening period and treatment period (Day 4): pre cold challenge and up to 8 hours post cold challenge. The duration of the cold challenge was 45 minutes.