QUC398 for Knee Osteoarthritis

Recruiting at 23 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Disqualifiers: Hip OA, Knee pain, Malalignment, MRI issues, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 13

Duration: 52 weeks

101 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

How is the drug QUC398 different from other treatments for knee osteoarthritis?

QUC398 is unique because it is being studied as a placebo (a treatment with no active ingredients) for knee osteoarthritis, which is different from other treatments like hyaluronic acid injections or vitamin D supplements that have active components aimed at reducing symptoms. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing a new treatment called QUC398 to see if it can help people with knee osteoarthritis. The study will check if QUC398 can reduce knee pain and protect the cartilage in the knee. Researchers also want to make sure it is safe and well-tolerated.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

This trial is for adults with knee osteoarthritis (OA) who weigh at least 50 kg, have a BMI of 18-35, and experience moderate to severe knee pain. They must have specific radiographic features in their knees confirming OA severity. Those with severe knee misalignment, patello-femoral pain, inability to undergo MRI scans, or previous use of ADAMTS-5 drugs like QUC398 cannot participate.

Inclusion Criteria

My knee X-ray shows moderate to severe arthritis.

Radiographic medial joint space width (mJSW) of 2 to 4 mm in men or 1.5 to 3.5 mm in women measured at the X=0.225 fixed point location within the medial tibio-femoral compartment of the target knee at Screening 1

I weigh at least 50 kg and my BMI is between 18 and 35.

Exclusion Criteria

History or current diagnosis of ECG abnormalities

I have knee pain diagnosed by a doctor.

I have never taken any ADAMTS-5 inhibitors, including QUC398.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive QUC398 or placebo via s.c. injections every 4 weeks to assess efficacy on knee OA pain and cartilage preservation

52 weeks

13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• QUC398

Trial Overview The study tests the effects of an experimental drug called QUC398 on knee pain and cartilage health in people with OA compared to a placebo. Participants will be randomly assigned to receive either the investigational treatment or a placebo to evaluate safety and effectiveness.

Participant Groups

Group I: QUC398 Experimental Treatment 1 Intervention

QUC398 150 mg/mL, solution for s.c. injection (1 mL). 2 injections will be applied per dose to complete the 300 mg

Group II: Placebo Placebo Group 1 Intervention

Placebo 0 mg/mL, solution for s.c. injection (1 mL). 2 injections will be applied per dose to ensure blinding

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

References

1. England pubmed.ncbi.nlm.nih.gov

Exercise and education versus saline injections for knee osteoarthritis: a randomised controlled equivalence trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Therapeutic trajectory following intra-articular hyaluronic acid injection in knee osteoarthritis--meta-analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A Pooled Analysis of Two Multicenter, Randomized Controlled Trials of a Single Intra-articular Injection of Gel-200 for Treatment of Osteoarthritis of the Knee. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Intraarticular sodium hyaluronate (Hyalgan) in the treatment of patients with osteoarthritis of the knee: a randomized clinical trial. Hyalgan Study Group. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Does vitamin D improve symptomatic and structural outcomes in knee osteoarthritis? A systematic review and meta-analysis. [2021]