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DFV890 for Familial Cold Autoinflammatory Syndrome (DFV890-FCAS Trial)

Phase 2

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, approximately 4 months

Awards & highlights

DFV890-FCAS Trial Summary

This trial is testing a new drug to see if it is safe and effective for people with FCAS. It will last up to 7 months.

Eligible Conditions

Familial Cold Autoinflammatory Syndrome

DFV890-FCAS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, approximately 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, approximately 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Ratio of fold change from baseline for white cell count (WCC)

Secondary outcome measures

Change from pre-baseline to post-baseline in Patient's global assessment of disease activity

Change from pre-baseline to post-baseline in Physician global assessment of autoinflammatory disease activity

Change from pre-baseline to post-baseline in Physician's severity assessment of autoinflammatory disease signs and symptoms

+1 more

Side effects data

From 2020 Phase 2 trial • 143 Patients • NCT04382053

Anaemia

Respiratory failure

Diabetes mellitus

Hyperglycaemia

COVID-19 pneumonia

Pulmonary embolism

Sepsis

Shock haemorrhagic

Polyneuropathy

Renal failure

Dyspnoea

Multiple organ dysfunction syndrome

Condition aggravated

Septic shock

Pneumonia

Amylase increased

Peripheral artery thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

DFV890 + SoC

Total

Standard of Care (SoC)

DFV890-FCAS Trial Design

1Treatment groups

Experimental Treatment

Group I: DFV890Experimental Treatment1 Intervention

DFV890

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DFV890

2021

Completed Phase 2

~150

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,197,346 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are being recruited for this research project?

"That is correct. The trial, which began recruitment on September 20th, 2021, is still looking for 6 patients at 1 location according to the latest update from clinicaltrials.gov"

Answered by AI

To what type of patients does this research apply?

"This study is only admitting six people who have muckle-wells syndrome and are between 18 and 80 years old."

Answered by AI

Can people below the age of 20 years old participate in this research project?

"The age range that is able to participate in this research begins at 18 years old and culminates at 80 years old."

Answered by AI

Are investigators looking for new participants at this time?

"This study, as indicated on clinicaltrials.gov, is looking for more participants. The trial was originally posted on September 20th, 2021 and the most recent update was on November 2nd, 2022."

Answered by AI

What is the Federal Drug Administration's opinion of DFV890?

"DFV890's safety is based on Phase 2 trial data, which means that while there is some evidence to support its safety, there is no clinical data yet demonstrating its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Study of Safety, Tolerability and Efficacy of DFV890 in Participants With Familial Cold Auto-inflammatory Syndrome (FCAS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04868968.