QUC398 for Knee Osteoarthritis

No longer recruiting at 27 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new treatment, QUC398, can reduce pain and improve knee cartilage in people with knee osteoarthritis. Participants will receive either the experimental treatment (QUC398) or a placebo to compare effects. The trial targets those with moderate to severe knee pain due to osteoarthritis for most days in the last three months. Individuals experiencing this level of knee pain may be suitable candidates. The goal is to determine if QUC398 is both effective and safe for managing symptoms. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that QUC398 is under investigation as a treatment for knee osteoarthritis. However, limited information exists about its safety and patient tolerance. The current trial is in an early stage, indicating that while the treatment has been tested in people, detailed safety data may not yet be complete. Early trials typically focus on assessing safety and determining the correct dosage.

For those considering participation in a QUC398 trial, it is crucial to understand that these early studies aim to identify any negative side effects. The studies are designed to closely monitor safety, with participants being carefully observed for any reactions to the treatment. Discuss any safety and side effect concerns with the trial team. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for osteoarthritis?

Unlike the standard treatments for knee osteoarthritis, which often involve oral medications like NSAIDs or corticosteroid injections, QUC398 is administered as a subcutaneous injection. This investigational drug is unique because it delivers a concentrated dose directly to the affected area, which could potentially offer more targeted relief. Researchers are excited about QUC398 because it may provide a new option for patients who do not respond well to existing treatments, and its novel delivery method might enhance efficacy while minimizing systemic side effects.

What evidence suggests that QUC398 might be an effective treatment for knee osteoarthritis?

Research has shown that QUC398, which participants in this trial may receive, might help people with knee osteoarthritis by reducing pain and protecting knee cartilage. Some early studies found that patients experienced less knee pain and maintained healthier cartilage. The drug aims to improve knee function, potentially making everyday activities like walking or climbing stairs easier. Although more research is needed, these early results offer promise for those with knee osteoarthritis. ^{1 2 3 4 6}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05462990

NCT05462990 | A Proof-of-concept Study to Examine ... The purpose of the study is to find out if the investigational treatment named QUC398 has beneficial effects on osteoarthritis knee pain and knee cartilage.

2. clinicaltrials.eu clinicaltrials.eu/inn/quc398/

QUC398: A Promising New Treatment for Knee Osteoarthritis This study aims to evaluate the drug's effectiveness in reducing pain, preserving cartilage, and improving overall knee function in patients suffering from this ...

3. trials.arthritis.org trials.arthritis.org/trials/NCT05462990

A Proof-of-concept Study to Examine QUC398 in Participants ... The purpose of the study is to find out if the investigational treatment named QUC398 has beneficial effects on osteoarthritis knee pain and knee cartilage.

4. clinicaltrial.be clinicaltrial.be/en/details/83574?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

A Proof-of-concept Study to Examine QUC398 in Participant... 1. Cartilage volume of the knee index region · 2. Change from baseline in KOOS Pain subscale · 3. Change from baseline in pain assessed by a Pain ...

5. withpower.com withpower.com/trial/phase-2-osteoarthritis-knee-9-2022-bd7df

QUC398 for Knee Osteoarthritis · Info for Participants 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.

6. fiercebiotech.com fiercebiotech.com/biotech/novartis-terminates-phase-2-osteoarthritis-trial-testing-adamts-5-inhibitor

Novartis culls phase 2 knee pain trial testing anti-ADAMTS- ... The Big Pharma company discontinued the study testing intra-articular injection QUC398 after an interim analysis found an “insufficient effect ...