Loading clinical trials...

A Proof-of-concept Study to Examine QUC398 in Participants With Knee OA | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

NCT05462990•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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

Locations (14)

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

Key Dates

Start Date

November 9, 2022

Primary Completion Date

August 2, 2024

Completion Date

April 8, 2025

Last Updated

January 28, 2026

Enrollment

101

ACTUAL participants

Conditions

Osteoarthritis, Knee

Interventions

QUC398

DRUG

Placebo

DRUG

Probiotic Supplements in Osteoarthritis

NCT07364578

Osteoarthritis, Knee

View study

RECRUITINGPHASE3

Rehabilitation for Arthritis of The Knee: mainTaining Improvement for Veterans

NCT06488144

Osteoarthritis, Knee

View study

RECRUITINGNA

Nurse-Led Telehealth vs In-Person Follow-Up After Total Knee Replacement

NCT07058623

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Probiotic Supplements in Osteoarthritis

Rehabilitation for Arthritis of The Knee: mainTaining Improvement for Veterans

Nurse-Led Telehealth vs In-Person Follow-Up After Total Knee Replacement

Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty

Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1

Effects of Movement Retraining on Knee Loading in Individuals With Knee Osteoarthritis