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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Osteoarthritis, Knee

In brief

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.

Key facts

Study ID

NCT05462990

Run by

Novartis Pharmaceuticals

People needed

101

Starts

2022-11-09

Expected to finish

2025-04-08

Last updated by the study team

2026-03-31

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Weight ≥ 50 kg and body mass index 18 -35 kg/m2 at Screening 1
• Kellgren-Lawrence grade 2 to 4 in the tibio-femoral compartment in the target knee confirmed by radiography in standing weight-bearing fixed flexion position and posterior-anterior view, at Screening 1
• mJSN 1-2 in the medial tibiofemoral compartment of the target knee, confirmed with Xray by central reader at Screening 1
• Symptomatic OA with moderate to severe pain (corresponding to Pain NRS ≥ 5 to ≤ 9) in the target knee for the majority of days in the last 3 months prior to Screening 1, as per participant's judgement
• Symptomatic OA with moderate to severe pain (corresponding to Pain NRS ≥ 5 to ≤ 9) in the target knee at Screening 1 and 2
• Moderate to severe OA pain (corresponding to Pain NRS ≥5 to ≤9) in the target knee during the last 7 days prior to Screening 3, confirmed by:
• Completed pain diary for at least 6 of the last 7 days prior to Screening 3, AND Diary reported Pain NRS ≥5 to ≤9 for at least 6 of the last 7 days prior to Screening 3
• KOOS pain subscale ≤ 60 in the target knee at Screening 1, Screening 2, and Screening 3

You may not qualify if…

• Painful ipsilateral hip OA defined as a Pain NRS ≥3 on the majority of days in the last 3 months prior to Screening 1, as reported by the patient
• Symptomatic, patello-femoral pain in the target knee as per investigator's examination at Screening 1
• Severe malalignment > 7.5º in the target knee (either varus or valgus), measured using standardized knee X-ray at Screening 1
• Patient unable or unwilling to undergo MRI or presenting absolute contraindications to MRI
• Previous exposure to any ADAMTS-5 drug, including QUC398.
• History or current diagnosis of ECG abnormalities
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Clinical Research of West Florida Inc — Tampa, Florida, United States
• Boston Univ School of Medicine — Boston, Massachusetts, United States
• West Clinical Research — Morehead City, North Carolina, United States
• Novartis Investigative Site — Southport, Queensland, Australia
• Novartis Investigative Site — Christchurch, Australia
• Novartis Investigative Site — St Leonards, Australia
• Novartis Investigative Site — Herlev, Denmark
• Novartis Investigative Site — Vejle, Denmark
• Novartis Investigative Site — Nice, France
• Novartis Investigative Site — Orléans, France
• Novartis Investigative Site — Sabadell, Barcelona, Spain
• Novartis Investigative Site — Leganés, Madrid, Spain
• Novartis Investigative Site — A Coruña, Spain
• Novartis Investigative Site — Seville, Spain

Full record on ClinicalTrials.gov

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