Study Description
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, and if it is safe and well tolerated.
This is a phase IIa study to establish the effect of QUC398 on pain and cartilage preservation in participants with symptomatic knee OA
Interventions
Placebo
QUC398
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
Other protocol-defined inclusion/exclusion criteria may apply
Study Location
Novartis Investigative Site
Recruiting
St Leonards,New South Wales,2065,Australia
Novartis Investigative Site
Recruiting
Christchurch,8011,Australia
Novartis Investigative Site
Recruiting
Southport,Queensland,4222,Australia
Novartis Investigative Site
Recruiting
Vejle,7100,Denmark
Novartis Investigative Site
Recruiting
Herlev,2730,Denmark
Novartis Investigative Site
Recruiting
Nice,Cedex1,06001,France
Novartis Investigative Site
Recruiting
Orleans,45100,France
Novartis Investigative Site
Recruiting
Paris,75012,France
Novartis Investigative Site
Recruiting
Barcelona,Cataluna,08022,Spain
Novartis Investigative Site
Recruiting
Sabadell,Barcelona,08208,Spain
Novartis Investigative Site
Recruiting
Sevilla,41010,Spain
Novartis Investigative Site
Recruiting
La Coruna,Galicia,15006,Spain
Novartis Investigative Site
Recruiting
Leganes,Madrid,28915,Spain
CoastalOrthoandSportsMedofSWFlorida .
Recruiting
Bradenton,Caitlin Towsley (941-792-1404) email: [email protected] -- David Cashen,34209 - Florida,United States
Meridien Research
Recruiting
Maitland,Lindsay Theisen (407-644-1165) email: [email protected] -- Eva Maria Heurich,32751 - Florida,United States
West Clinical Research Private Clinic
Recruiting
Morehead City,Millicent Clark email: [email protected] -- Jeffrey K Moore,28557 - North Carolina,United States
Boston Univ School Of Medicine .
Recruiting
Boston,Rutvi Patel email: [email protected] -- Tuhina Neogi,02118 - Massachusetts,United States
Clinical Research of West FL Inc. .
Recruiting
Tampa,Rachel Matthews (813-870-1292) email: [email protected] -- Paul A Lunseth,33603 - Florida,United States
Worldwide Contacts
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