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NCT04868968 · ClinicalTrials.gov registry record · Phase 2
Study of Safety, Tolerability and Efficacy of DFV890 in Participants With Familial Cold Auto-inflammatory Syndrome (FCAS)
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT04868968: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT04868968 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04868968, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
The purpose of this phase II study was to assess the safety, tolerability and efficacy of DFV890 in participants with FCAS.
Primary Outcome
A cold challenge was performed during the screening period and on Day 4 of the treatment period. Fold change from pre-challenge to highest post-challenge value of WCC was defined as the ratio of the highest post-challenge WCC value to the pre-challenge WCC value. The ratio of fold change was defined as treatment fold change divided by the screen fold change. A value of less than 1 for the ratio of fold change indicates a lower relative increase of WCC in the treatment than in the screening perio
Interventions
- DRUG DFV890
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2021-09-20 |
| Est. Completion | 2023-05-05 |
| Phase | Phase 2 |
What the finished NCT04868968 record still lists
NCT04868968 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which DFV890 is the first listed.
NCT04868968 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04868968 about?
NCT04868968 is a clinical study titled "Study of Safety, Tolerability and Efficacy of DFV890 in Participants With Familial Cold Auto-inflammatory Syndrome (FCAS)". The purpose of this phase II study was to assess the safety, tolerability and efficacy of DFV890 in participants with FCAS.
What is the current status of trial NCT04868968?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2021-09-20. Estimated completion is 2023-05-05.
What interventions are being tested in trial NCT04868968?
The interventions under investigation include: DFV890 (DRUG).
Who is sponsoring clinical trial NCT04868968?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04868968's enrollment target sits among peer trials
4 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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