Knee Cartilage Injury MedDRA version: 14.1 Level: PT Classification code 10007710 Term: Cartilage injury System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Product Name: AS902330
Product Code: AS902330
Pharmaceutical Form: Powder and solvent for solution for injection
Current Sponsor code: AS902330
Concentration unit: µg microgram(s)
Concentration type:
Sponsors
Merck Serono S.A. - Geneva
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion, all of the following criteria must be fulfilled: · Acute cartilage lesion of ICRS grade 2 to 4 at the femoral condyle of the knee (= target knee) · Age: 18 to 45 years · Sex: male or female. Women of childbearing potential (i.e. all female patients after puberty unless they are post-menopausal for at least two years or surgically sterile) must have negative serum and urine pregnancy tests at screening and Visit 1, respectively, and must use a highly effective method of contraception (i.e. two barrier methods or hormonal intrauterine device or use of an oral female contraceptive) from 4 weeks prior to the first dose until 12 weeks after the last dose of trial medication · History of pain and effusion of the target knee post-injury · Injury within 4 to 12 weeks prior to 1st treatment with IMP · Written informed consent prior to any trial-related activity Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 128 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Personal medical history of OA in either knee • Any previous surgery on the target knee • History of swelling of the target knee along with pain on weight-bearing, or arthroscopy for diagnostic purposes during the 12 months preceding injury • Corticosteroid (i.a.) injection into the target knee during the preceding 12 months • Any other i.a. injection into the target knee during the preceding 3 months • Any concurrent injury (e.g. arthrolith, anterior cruciate ligament rupture, meniscus tear) of the target knee requiring surgical intervention • OA or any pre-existing cartilage damage in the target knee, as revealed by MRI • Open growth plate, as revealed by MRI •Diagnostic arthroscopy after injury and within 4 weeks prior to treatment start • Legal incapacity or limited legal capacity • Patients who are imprisoned or institutionalized by regulatory or court order • Pregnancy or lactation • Participation in another clinical trial within the past 30 days • Any condition or findings in the medical history or in the pre-trial assessments that in the opinion of the Investigator constitutes a risk or contraindication for participation in the trial or that could interfere with the trial objectives, conduct or evaluation • Known hypersensitivity to the trial treatment or diluents • Significant renal or hepatic impairment, as indicated by o Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (AP) >3 times the upper limit of normal (ULN) o Total bilirubin >1.5 times ULN (except in case of Gilbert’s syndrome) o Creatinine >1.5 times ULN • Hemoglobin <5.5 mmol/L, white blood cell count (WBC) <2.5 x 109/L, or platelets <75 x 109/L). • Any suspicion of i.a. infection • Any known active infections that may compromise the immune system such as HIV, Hepatitis B or C infection • History of sarcoma and/or of other active malignancy within five years, except adequately treated basal cell or squamous cell carcinoma of the skin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy of three weekly i.a. injections of 10, 30, or 100 µg AS902330 in patients with acute cartilage injury of the knee based on MRI measurements of the defect volume. ;Secondary Objective: Secondary objectives are to support the efficacy of AS902330 in patients with acute cartilage injury of the knee by morphological and symptomatic outcome scores as well as to confirm its safety and local tolerability.;Primary end point(s): Relative change in cartilage defect volume over 12 months based on central magnetic resonance imaging (MRI).;Timepoint(s) of evaluation of this end point: Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy (in order of priority): (a) The relative and absolute changes in cartilage defect volume and thickness in the target knee from baseline to 6 months and the absolute changes over 12 months (b) Changes in the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score for the integration of rebuilt cartilage and its surface structure at 3, 6 and 12 months (c) Changes in the Boston Leeds Osteoarthritis Knee Score (BLOKS) at 12 months (d) Changes in the ICRS grades over 6 and 12 months (e) The relative and absolute change in cartilage defect volume/thickness in the target knee from baseline to 3 months (f) Changes in the symptom scores (Knee Injury and Osteoarthritis Outcome Score [KOOS], International Knee Documentation Committee [IKDC], global evaluation of treatment benefit) at visits over 12 months Safety: • Systemic and local AEs over 12 months • Acute inflammatory events, i.e., increase of pain of at least 30 mm on a 100 mm visual analog scale (VAS) along with selfreported swelling within 3 days post-injection • Changes in safety laboratory measurements and vital signs over 12 months • Occurrence of FGF18ab;Timepoint(s) of evaluation of this end point: 3, 6 and 12 months | — |
Countries
Austria, Bulgaria, Canada, Germany, Hungary, Serbia, Slovenia, South Africa
Contacts
Public ContactCommunication Centre Merck KGaA
Merck KGaA
Outcome results
None listed