NCT05462990

A Proof-of-concept Study to Examine QUC398 in Participants With Knee OA

A Randomized, Two-arm, Placebo-controlled, Participant, Investigator and Sponsor-blinded, Proof-of-concept Study Investigating the Efficacy, Safety and Tolerability of QUC398 in Patients With Symptomatic Knee Osteoarthritis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study was to find out if the investigational treatment named QUC398 had beneficial effects on osteoarthritis (OA) knee pain and knee cartilage, and if it was safe and tolerated.

Detailed description

This was a non-confirmatory study using a randomized, placebo-controlled, parallel-group, participant, investigator and sponsor-blinded design to investigate efficacy, safety and tolerability of subcutaneous injections of QUC398 300 mg vs placebo every 4 weeks (q4w) in participants with symptomatic knee OA.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	QUC398	QUC398 150 mg/mL, solution for subcutaneous (s.c) injection (1 mL). 2 injections were administered to complete 300 mg.
DRUG	Placebo	Matching Placebo solution for s.c. injection (1 mL). 2 injections were administered per dose to ensure blinding.

Timeline

• Start date: 2022-11-09
• Primary completion: 2024-08-02
• Completion: 2025-04-08
• First posted: 2022-07-18
• Last updated: 2026-03-31
• Results posted: 2026-01-28

Locations

14 sites across 5 countries: United States, Australia, Denmark, France, Spain

Regulatory

• FDA-regulated drug study