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QUC398 for Knee Osteoarthritis

Verified Trial
Phase 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 1 (day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Awards & highlights

Study Summary

This trialtests if a new treatment helps reduce knee pain and protect knee cartilage, and if it is safe.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While the side effects are not specified here, common risks may include allergic reactions, gastrointestinal issues, headaches or dizziness. The trial aims to determine if QUC398 is safe and well tolerated by participants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh at least 50 kg and my BMI is between 18 and 35.
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My knee X-ray shows moderate to severe arthritis.
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I have moderate to severe knee pain from arthritis, rated 5-9 on a pain scale.
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I have had moderate to severe knee pain for most of the past week.
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My knee pain score is 60 or less on the KOOS pain scale.
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I weigh at least 50 kg and my BMI is between 18 and 35.
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My knee X-ray shows moderate to severe arthritis.
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I have had moderate to severe knee pain most days in the last 3 months.
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I have moderate to severe knee pain from arthritis, rated 5-9 on a pain scale.
Select...
I have had moderate to severe knee pain for most of the past week.
Select...
My knee pain score is 60 or less on the KOOS pain scale.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1 (day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1 (day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain sub-scale at Week 12
Secondary outcome measures
Cartilage volume of the knee index region
Pain
Change from baseline in Patient's Global Assessment (PGA) as assessed by NRS
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: QUC398Experimental Treatment1 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: PlaceboPlacebo Group1 Intervention
Placebo 0 mg/mL, solution for s.c. injection (1 mL). 2 injections will be applied per dose to ensure blinding

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,856 Previous Clinical Trials
4,197,607 Total Patients Enrolled
12 Trials studying Osteoarthritis
2,590 Patients Enrolled for Osteoarthritis

Media Library

Placebo (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05462990 — Phase 2
Osteoarthritis Research Study Groups: QUC398, Placebo
Osteoarthritis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05462990 — Phase 2
Placebo (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05462990 — Phase 2
Osteoarthritis Patient Testimony for trial: Trial Name: NCT05462990 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants can join this research endeavor?

"Affirmative. The information hosted on clinicaltrials.gov confirms that this medical research, initially posted on November 9th 2022, is actively enrolling volunteers. Approximately 98 participants must be enrolled from a single site."

Answered by AI

Has QUC398 received governmental endorsement by way of FDA approval?

"As QUC398 is being tested in Phase 2 clinical trials, there is some evidence of safety but no indication yet that it is effective. Accordingly, Power gave the medication a rating of 2 on its scale from 1 to 3."

Answered by AI

Is recruitment currently ongoing for this experiment?

"According to the data found on clinicaltrials.gov, this investigation is still actively looking for individuals that are willing to participate. The initial posting of the trial occurred on November 9th 2022 and was revised most recently on November 10th 2022."

Answered by AI

Who has the prerequisites to take part in this trial?

"The current medical trial is searching for 98 people aged 40-80 who suffer from osteoarthritis of the knee. All participants must meet a specified Weight ≥ 50 kg and body mass index 18 -35 kg/m2, symptoms with moderate to severe pain (Pain NRS ≥ 5 to ≤ 9) in the past 3 months prior to Screening 1 as well as during Screening 1 and 2, diary reported Pain NRS between 5-9 over 6 days before Screening 3, KOOS subscale scoring below 60 at all three screenings, Kellgren-Lawrence grade of 2-4 confirmed by radiography while weight bearing on a"

Answered by AI

Is the age limit of candidates for this research restricted to individuals under 35 years old?

"This research project seeks participants of between 40 and 80 years old. In comparison, there are 38 studies aimed at minors aged 18 or younger and 656 that target individuals over 65."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Clinical Research of West Florida
Other
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
0

Why did patients apply to this trial?

Help myself and others. Happy to help with this trial. To help myself and to help others.
PatientReceived no prior treatments
Seeking treatment that aids in cartilage regeneration. I have tried many other approaches & none have worked.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long do screening visits take and how long are the trails?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Phone Call
Most responsive sites:
  1. Clinical Research of West Florida: < 24 hours
  2. Novartis Investigative Site: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Proof-of-concept Study to Examine QUC398 in Participants With Knee OA
2022. "A Proof-of-concept Study to Examine QUC398 in Participants With Knee OA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05462990.
All > Osteoarthritis Knee
~26 spots leftby Nov 2024
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