This phase 2a trial is an international, multicenter, randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of one single intra-articular (IA) injection of 4P004 or placebo in: * patients between 40 and 80 years of age, * with synovitis and grade 2 to 4 osteoarthritis (OA) of the knee according to Kellgren and Lawrence (KL) classification.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
129
Single intra-articular injection in the knee joint
Single intra-articular injection in the knee joint
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
NOT_YET_RECRUITINGSkylight Health Research Burlington
Burlington, Massachusetts, United States
NOT_YET_RECRUITINGDurham Bone and Joint Specialists
Ajax, Canada
RECRUITINGSJHC London Rheumatology Centre
London, Canada
NOT_YET_RECRUITINGG.R.M.O. (Groupe de recherche en maladies osseuses) Inc
Québec, Canada
NOT_YET_RECRUITINGParker Institute Bispebjerg, Frederiksberg Hospital
Frederiksberg, Denmark
NOT_YET_RECRUITINGSanos Clinic Herlev
Herlev, Denmark
NOT_YET_RECRUITINGCHU Montpellier
Montpellier, France
NOT_YET_RECRUITINGChU de Nice
Nice, France
NOT_YET_RECRUITINGHôpital Cochin
Paris, France
NOT_YET_RECRUITING...and 11 more locations
Change from Baseline at Week 4 in the weekly average of Target Knee (TK) daily pain intensity using the WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain subscore
The WOMAC is a questionnaire widely used in the evaluation of knee osteoarthritis. It contains 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items). Scores are calculated for each subscale and summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for all three subscales gives a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time frame: Baseline and Week 4
Change from Baseline at Week 2, Week 6, Week 8, Week 10 and Week 12 in the weekly average of TK (Target Knee) daily pain intensity using the WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain subscore
The WOMAC is a questionnaire widely used in the evaluation of knee osteoarthritis. It contains 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items). Scores are calculated for each subscale and summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for all three subscales gives a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time frame: Baseline, Week 2, Week 6, Week 8, Week 10 and Week 12
Change from Baseline at Week 2, Week 4, Week 8 and Week 12 in the NRS (Numeric Rating Scale) pain (scale 0-10) in a nominated pain aggravating activity
The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time, using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable.
Time frame: Baseline, Week 2, Week 4, Week 8 and Week 12
Change from Baseline at Week 2, Week 4, Week 8 and Week 12 in WOMAC (Western Ontario and McMaster Universities Arthritis Index) subscores and total score
The WOMAC is a questionnaire widely used in the evaluation of knee osteoarthritis. It contains 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items). Scores are calculated for each subscale and summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for all three subscales gives a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time frame: Baseline, Week 2, Week 4, Week 8 and Week 12
Change from Baseline at Week 2, Week 4, Week 8 and Week 12 in the Patient Global Assessment of Osteoarthritis (PGA-OA)
The PGA-OA is a 1-item questionnaire designed to assess the participant's impression of disease severity adapted from Guy et al., 1976, to the specific disease as a Patient-reported Outcome measurement "Considering all the ways your knee osteoarthritis affects you, how are you doing these last seven days ?". PGA-OA is measured on a 5-point Likert scale, with higher scores indicating worse symptoms (1= "very good" to 5 = "very poor").
Time frame: Baseline, Week 2, Week 4, Week 8 and Week 12
Percentage (%) of OMERACT-OARSI Responders at Week 2, Week 4, Week 8 and Week 12
Time frame: Week 2, Week 4, Week 8 and Week 12
Incidence and severity of TEAEs (Treatment-Emergent Adverse Events) during the trial
Time frame: From randomization to end of trial, up to 12 weeks
Absolute changes from Baseline in clinical laboratory assessment - hematology parameter: total blood cells count (in cell/L)
Time frame: From randomization to end of trial (up to 12 weeks)
Absolute changes from Baseline in clinical laboratory assessments - hematology parameter: hemoglobin (in g/L)
Time frame: From randomization to end of trial (up to 12 weeks)
Absolute changes from Baseline in clinical laboratory assessment - blood chemistry: AST (in U/L)
Time frame: From randomization to end of trial (up to 12 weeks)
Absolute changes from Baseline in clinical laboratory assessment - blood chemistry: ALT (in U/L)
Time frame: From randomization to end of trial (up to 12 weeks)
Absolute changes from Baseline in clinical laboratory assessment - blood chemistry: lipase (in U/L)
Time frame: From randomization to end of trial (up to 12 weeks)
Absolute changes from Baseline in clinical laboratory assessment - blood chemistry: fasting glycemia (in mmol/L)
Time frame: From randomization to end of trial (up to 12 weeks)
Absolute changes from Baseline in clinical laboratory assessment - blood chemistry: total bilirubin (in umol/L)
Time frame: From randomization to end of trial (up to 12 weeks)
Absolute changes from Baseline in Vital signs: systolic and diastolic blood pressure (BP)
Time frame: From randomization to end of trial (up to 12 weeks)
Absolute changes from Baseline in Vital signs: pulse rate
Time frame: From randomization to end of trial (up to 12 weeks)
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