QUC398 for Knee Osteoarthritis
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.12345Why 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.12346
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive QUC398 or placebo via s.c. injections every 4 weeks to assess efficacy on knee OA pain and cartilage preservation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- QUC398
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
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