RecruitingKnee OsteoarthritisSynovitis of Knee
A Trial to Investigate the Safety and Efficacy of Intra-articular 4P004 Injection in Subjects With Knee Synovitis and Osteoarthritis
Eligible age
40–80 yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
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About this study
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.
Sponsor: 4Moving Biotech
You may qualify if…
- ✓ 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.
- ✓ Ambulatory (single assistive devices such as canes allowed).
- ✓ Widespread Pain Index (WPI) ≤ 4.
- ✓ Pain NRS (0-10) \< 4 in the contralateral knee.
You may not qualify if…
- ✕ 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.
- ✕ Any partial knee replacement of the TK.
- ✕ Acute fracture or IA trauma to the TK within 12 months prior to the screening visit.
- ✕ Major knee surgery performed within the previous 12 months or planned during the trial.
- ✕ Arthroscopy of the TK within 6 months prior to the screening visit.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07225829 · last updated 2026-04-14