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

NCT ID: NCT05462990

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-09
• Study Completion Date: 2025-04-08

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

QUC398 300 mg

QUC398 was administered subcutaneous every 4 weeks during 48 weeks.

Group Type: EXPERIMENTAL

QUC398

Intervention Type: DRUG

QUC398 150 mg/mL, solution for subcutaneous (s.c) injection (1 mL). 2 injections were administered to complete 300 mg.

Placebo

Placebo was administered subcutaneous every 4 weeks during 48 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo solution for s.c. injection (1 mL). 2 injections were administered per dose to ensure blinding.

Interventions

QUC398

QUC398 150 mg/mL, solution for subcutaneous (s.c) injection (1 mL). 2 injections were administered to complete 300 mg.

Intervention Type: DRUG

Placebo

Matching Placebo solution for s.c. injection (1 mL). 2 injections were administered per dose to ensure blinding.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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

Countries

United States; Australia; Denmark; France; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2021-002795-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-509274-28-00

Identifier Type: OTHER

Identifier Source: secondary_id

CQUC398A12201

Identifier Type: -

Identifier Source: org_study_id