NCT04886258

Study of Efficacy, Safety and Tolerability of DFV890 in Patients With Knee Osteoarthritis

A Randomized, Two-arm, Placebo-controlled, Participant and Investigator-blinded Study Investigating the Efficacy, Safety and Tolerability of DFV890 in Patients With Symptomatic Knee Osteoarthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This was a double-blinded, two-arm, phase 2a study to assess efficacy, safety and tolerability of DFV890 in participants with symptomatic knee osteoarthritis.

Detailed description

The purpose of the Phase 2a proof of concept study was to evaluate the safety and tolerability of DFV890 in participants with symptomatic knee OA, and to determine the efficacy of DFV890 in reducing knee pain as evidenced by change in KOOS (knee injury and osteoarthritis outcome score). The study had a screening period up to 45 days, a treatment period of 12 weeks and a 4-week follow-up period. At most, the study duration was 21 weeks.

Conditions

• Symptomatic Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	DFV890	DFV890 was administered orally twice per day, 10 mg during 2 weeks and 25 mg during the next 10 weeks.
DRUG	Placebo	Matching Placebo was administered orally twice per day during 12 weeks.

Timeline

• Start date: 2021-09-20
• Primary completion: 2024-12-14
• Completion: 2024-12-23
• First posted: 2021-05-14
• Last updated: 2026-03-31
• Results posted: 2026-01-28

Locations

31 sites across 8 countries: United States, Argentina, Czechia, Germany, Hungary, Romania, Slovakia, Spain

Regulatory

• FDA-regulated drug study