A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof of Concept Trial to Investigate the Efficacy and Safety of Intra-articular 4P004 in Subjects With Knee Synovitis and Osteoarthritis
4Moving Biotech
Summary
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.
Eligibility
- Age range
- 40–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants who have the capacity to give informed consent and who are willing to comply with all trial related procedures and assessments. * Participants between 40 and 80 years of age. * Female participant of childbearing potential (defined as any woman unless postmenopausal for at least one year or surgically sterile) must use highly effective methods of contraception as defined in the protocol. Highly effective contraceptive measures must be continued throughout the trial until the final visit. * Bodyweight \> 40 kg. * Body mass index (BMI) ≥ 18.5 and ≤ 35. * Ambula…
Interventions
- Drug4P004
Single intra-articular injection in the knee joint
- DrugPlacebo (NaCl 0.9%)
Single intra-articular injection in the knee joint
Locations (22)
- Tucson Orthopaedic InstituteTucson, Arizona
- Northwestern University Feinberg School of MedicineChicago, Illinois
- Skylight Health Research BurlingtonBurlington, Massachusetts
- Durham Bone and Joint SpecialistsAjax
- SJHC London Rheumatology CentreLondon
- G.R.M.O. (Groupe de recherche en maladies osseuses) IncQuébec