NCT04868968

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this phase II study was to assess the safety, tolerability and efficacy of DFV890 in participants with FCAS.

Detailed description

This was an open-label, single-arm, multiple dose, phase II study to assess safety, tolerability and clinical efficacy of DFV890 in participants with FCAS who showed evidence of inflammatory activity after the cold challenge performed during screening. The study included a screening period, a treatment period and a follow-up period.

Conditions

• Familial Cold Autoinflammatory Syndrome

Interventions

Type	Name	Description
DRUG	DFV890	100 mg of DFV890 film coated tablets twice daily (b.i.d.). for 3 days starting in the morning of Day 1 and 100 mg of DFV890 in the morning on the fourth day.

Timeline

• Start date: 2021-09-20
• Primary completion: 2022-12-13
• Completion: 2023-05-05
• First posted: 2021-05-03
• Last updated: 2024-10-09
• Results posted: 2024-05-03

Locations

3 sites across 3 countries: United States, France, Germany

Regulatory

• FDA-regulated drug study