A Trial to Investigate the Safety and Efficacy of Intra-articular 4P004 Injection in Subjects With Knee Synovitis and Osteoarthritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
Sponsor4Moving Biotech
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Pregnant or breastfeeding women.
Significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the TK (varus > 10°, valgus > 10°) by radiography.
Secondary OA such as joint dysplasia, aseptic osteonecrosis, joint infection, acromegaly, Paget disease, hemochromatosis, joint crystal disease or any inflammatory joint disease.
Any known active infections including skin infections at the site injection or increased predisposition for the development of infections.
Trial design
Treatments tested in this trial
- 4P004
- Placebo (NaCl 0.9%)
Treatment groups
129 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov