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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 screening and treatment (day 4): 1 hour pre and 2, 3, 5, 9 and 24 hours post. scheduled time refers to the time post-meal (screening) and to the time post-dose (treatment). the start of the cold challenge is at 1 hour post and the duration is 45 minutes.
Awards & highlights
No Placebo-Only Group

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening and treatment (day 4): 1 hour pre and 2, 3, 5, 9 and 24 hours post. scheduled time refers to the time post-meal (screening) and to the time post-dose (treatment). the start of the cold challenge is at 1 hour post and the duration is 45 minutes.
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening and treatment (day 4): 1 hour pre and 2, 3, 5, 9 and 24 hours post. scheduled time refers to the time post-meal (screening) and to the time post-dose (treatment). the start of the cold challenge is at 1 hour post and the duration is 45 minutes. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ratio of Fold Change From Pre-challenge to the Highest Post-challenge Value of White Cell Count (WCC) Between Treatment and Screening Period
Secondary study objectives
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Patient's Global Assessment of Disease Activity
Physician Global Assessment of Autoinflammatory Disease Activity
+1 more

Side effects data

From 2020 Phase 2 trial • 143 Patients • NCT04382053
7%
Anaemia
6%
Respiratory failure
6%
Diabetes mellitus
6%
Hyperglycaemia
3%
COVID-19 pneumonia
1%
Sepsis
1%
Shock haemorrhagic
1%
Pulmonary embolism
1%
Polyneuropathy
1%
Renal failure
1%
Dyspnoea
1%
Multiple organ dysfunction syndrome
1%
Condition aggravated
1%
Septic shock
1%
Pneumonia
1%
Amylase increased
1%
Peripheral artery thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
DFV890 + SoC
Total
Standard of Care (SoC)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,913 Previous Clinical Trials
4,253,159 Total Patients Enrolled
~1 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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