Symptomatic osteoarthritis (OA) of the knee. MedDRA version: 17.1 Level: SOC Classification code 10028395 Term: Musculoskeletal and connective tissue disorders System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: fasitibant chloride as bis-hydrochloride
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: fasitibant chloride (as bis hydrochloride)
CAS Number: 883
Sponsors
Menarini Ricerche Spa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Properly executed written informed consent. 2.Male or female patients 40-80 years old and with a BMI =65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1.Inability to personally provide written informed. 2.Inability to understand or collaborate with study procedures and requirements, including answering to the study questionnaire/symptoms reporting. 3.Patients who participated in another clinical trial within 30 days (90 days in case of OA trial) prior to screening. 4.Patients with Kellgren Lawrence Grade 1 or Grade 4 OA of the knee. 5.Knee condition representing on Investigator’s judgment an indication for surgery. 6.OA secondary to inflammatory/autoimmune forms of arthritis, septic arthritis, or genetic diseases, which have a distinct impact on the outcome. 7.Patients with acute fractures, severe loss of bone density, history of aseptic necrosis, isolated patella-femoral syndrome, or joint replacement in the affected knee. 8.Patients with OA predominant in the lateral compartment, or any significant valgus deformity. 9.Patients who -as per Investigator’s judgment- have any clinically significant or unstable disease or condition interfering with the evaluation of the safety and efficacy of study treatment along the study period. 10.History of symptomatic severe hip OA or painful hip prosthesis. 11.Major injury (including ligament sprains or muscle/tendon strains > grade 2 and meniscal tears > grade 2) or major surgery (including arthroscopic interventions on cartilage or meniscus) to the index knee. 12.Any musculoskeletal pain > 30 mm on a 100 mm VAS that could interfere with the index knee pain assessment (e.g. local or radiating pain in any part of the lower extremities). 13.Clinically significant venous or lymphatic stasis in the relevant limb. 14.Acupuncture and physiotherapy in the last 4 weeks prior to randomisation, or likely to start during the course of the study. 15.Any pharmacological treatment of concomitant disease(s) started or changed during 4 weeks prior to randomisation, or likely to be changed during the course of the study. 16.Use of systemic or topical corticosteroids > 10 mg prednisolone equivalent per day, or immunosuppressant drugs during 30 days prior to randomisation, or likely to be used during the course of the study. 17.Use of any pain or OA medication and OA dietary supplements (e.g. NSAIDs, COX-2 inhibitors, analgesics, antidepressive OA agents and chondroitin sulfate), including topical treatments, within a minimum of 5 times their half-life prior to randomisation and during the course of the study. 18.Viscosupplementation (intra-articular injection of hyaluronic acid) to the target knee administered < 6 months prior to randomisation and/or scheduled during the course of the study other than as specified in the protocol. 19.History of hypersensitivity/allergy to drugs including paracetamol and disinfectants (antimicrobial soaps and /or povidone-iodine solution). 20.Patients with known hypersensitivity to hyaluronate preparations or allergy to avian proteins, feathers, and eggs. 21.Use of any medications that are substrate of CYP3A4 and/or moderate or strong CYP3A4 inhibitors during the 4 weeks prior to Randomisation and the overall study duration. 22.Patients with any of the following: a.clinically relevant cardiovascular, pulmonary, gastro-intestinal, haematological, neurologic, psychiatric, or infectious diseases, or unstable metabolic diseases, or malignant neoplasms that, in the opinion of the Investigator, may pose the patient at risk, or confound the efficacy and safety results of the study; b.clinically relevant (according
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the potential additive therapeutic effect of fasitibant administered as single IA injection in extemporaneous combination with sodium hyaluronate as an efficacious symptom modifying treatment of knee OA.;Secondary Objective: To evaluate the safety and tolerability of a single IA injection of fasitibant 2.5 mg as 1 ml solution in extemporaneous combination with sodium hyaluronate 20mg as 2ml solution to patients with symptomatic knee OA.;Primary end point(s): Primary efficacy endpoint: the change of the WOMAC VA 3.1 A (total pain) subscore from baseline (Visit 2) over 2 weeks after randomisation;Timepoint(s) of evaluation of this end point: from baseline over 2 weeks after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Efficacy endpoints: over 2 and 6 weeks after randomization Safety endpoints: the safety will be evaluated between dosing time (V2) over 12 weeks (+/- 2 days) after treatment.;Secondary end point(s): SECONDARY EFFICACY ENDPOINTS •The changes from baseline (Visit 2) over 2 weeks (excluding WOMAC VA 3.1 A, which represents the primary end-point) and over 6 weeks after randomisation, and at each post-treatment time-point until week 6, of: -WOMAC VA 3.1 A subscore (total pain): VAS subtotal score 0-500 mm; -WOMAC VA 3.1 A1 subscore (walking pain on a flat surface): VAS 0-100 mm; -WOMAC VA 3.1 B subscore (stiffness): VAS subtotal score 0-200; -WOMAC VA 3.1 C subscore (functional impairment): VAS subtotal score 0-1700 mm; -WOMAC VA 3.1 global index (sum of subscores A, B and C): VAS total score 0-2400 mm; -Pain at rest: VAS 0-100 mm; -Pain after 15-meter walk: VAS 0-100 mm; -Patient Global Assessment: VAS 0-100 mm; •AUC0w-2w and AUC0w-6w of WOMAC VA 3.1 A subscore (total pain). •Responses to treatment according to Minimal Clinically Important Improvement (MCII) criteria over 2 and 6 weeks after randomisation, for WOMAC VA 3.1 A subscore (total pain), WOMAC VA 3.1 C subscore (functional impairment) and Patient Global Assessment, in terms of: -absolute MCII; change from baseline = 15 mm (by using normalized scale 0-100); -relative MCII; change from baseline = 20%. •Response to treatment according to Patient Acceptable Symptom State (PASS) criterion, over 2 and 6 weeks after randomisation defined as WOMAC VA 3.1 A subscore (total pain), WOMAC VA 3.1 C subscore (functional impairment) and Patient Global Assessment, in terms of absolute value < 40 mm (by using normalized scale 0-100). •Response to treatment according to OMERACT-OARSI criteria over 2 and 6 weeks after randomisation, and at each post-treatment time point until week 6. •Use of RM (time to first use, and overall consumption and number of days requirin | — |
Countries
Czech Republic
Contacts
Public ContactProject Management Department
CROMSOURCE srl
Outcome results
None listed