Knee osteoarthritis MedDRA version: 21.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859
Conditions
Interventions
Product Code: QUC398
Pharmaceutical Form: Solution for injection
INN or Proposed INN: -
CAS Number: -
Current Sponsor code: QUC398
Other descriptive name: QUC398
Concentration unit: mg/ml milligram(s)
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Weight = 50 kg and a body mass index (BMI) between 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 •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 •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. Additional protocol specified criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
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 relevant cardiovascular diseases and ECG abnormalities. Additional protocol specified criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess efficacy of QUC398 vs placebo in relieving OA pain in the target knee;Secondary Objective: •To assess the efficacy of QUC398 vs placebo in preservation of cartilage in the medial compartment of the target knee •To assess the efficacy of QUC398 vs placebo in relieving OA pain in the target knee over time •To assess the efficacy of QUC398 vs placebo in relieving clinical symptoms and improving function in the target knee over time •To assess the safety and tolerability of QUC398 vs placebo.;Primary end point(s): Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain sub-scale at Week 12 ;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Change from baseline in cartilage volume of the knee index region at Week 52, as determined from the automated segmentation of 3D-MRI scans •Change from baseline in KOOS Pain subscale at Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 •Change from baseline in pain assessed by a Pain Numerical Rating Scale (NRS) at Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 •Change from baseline in total KOOS at Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 •Change from baseline in KOOS subscales: Other symptoms, Function in daily living, Function in sport and recreation, and Knee related quality of life at Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 •Change from baseline in Patient's Global Assessment (PGA) as assessed by NRS at Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 •Systemic and local Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Electrocardiogram parameters (ECGs), Vital signs, Laboratory tests;Timepoint(s) of evaluation of this end point: As specified in the secondary endpoints | — |
Countries
Australia, Denmark, France, New Zealand, Norway, Spain, United States
Contacts
Public ContactMedisinsk informasjon
Novartis Norge AS
Outcome results
None listed