| NCT ID | NCT06994546 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maxigen Biotech Inc. |
| Condition | Knee Osteoarthristis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-03-11 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-03-11 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to evaluate the real-world effectiveness and safety of ArtiBest in the treatment of knee osteoarthritis. The main questions it aims to answer are: 1. The change from baseline The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at 26 weeks post injection. 2. The change from baseline VAS resting pain score at 12 and 26 weeks post injection. 3. The change from baseline The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at 12 weeks post injection. 4. The change from baseline Patient's Global Assessment PGA) using VAS scoring at 12 and 26 weeks post injection. 5. The OMERACT OARSI responder rate at 12 and 26 weeks post injection. 6. The VAS satisfaction score at 12 and 26 weeks post injection 7. The incidence of Adverse events reported during the study period. Participants will undergo a single injection of ArtiBest at treatment visit, and three follow up visits at week 4 , 12 , and 26.
Eligibility Criteria
Inclusion Criteria: * Age from 35 to 85 years. * Subject with x ray imaging evidence of knee OA as Kellgren Lawrence grade = 2 or 3 within 1 month at screening. * Subject diagnosed with mild to moderate knee OA, particularly in patients who failed to respond adequately to conservative nonpharmacologic therapies or analgesics. * Subject with a 100 mm VAS resting pain score ≥ 30 mm in the studied knee at both the screening and treatment visit (screening visit and treatment visit can be on the same day) * Able and willing to comply with all study visits and procedures. * Willin g and capable of providing written informed consent. Exclusion Criteria: * Subjects with known hypersensitivity to hyaluronate. * Subjects with infections or skin diseases in the area of the injection site. * Pregnancy or breast feeding woman. * Joining other interventional trial s within 3 months prior to injecting this study product * Subject receive an intra articular (IA) injection of Hyaluronic Acid (HA) and/or steroid in target knee within 6 months prior to the trial * Subjects with rheumatoid arthritis * Any surgery to the target knee within the 12 months prior to the trial, or surgery to the contralateral knee or other weight bearing joint if it will interfere with knee assessments
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06994546 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 85 Years, studying Knee Osteoarthristis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06994546 currently recruiting?
Yes, NCT06994546 is actively recruiting participants. Contact the research team at lirong.chen@mbi.com.tw for enrollment information.
Where is the NCT06994546 trial being conducted?
This trial is being conducted at Kaohsiung City, Taiwan.
Who is sponsoring the NCT06994546 clinical trial?
NCT06994546 is sponsored by Maxigen Biotech Inc.. The trial plans to enroll 60 participants.