Evaluation of CYT-108, a Recombinant Protease Inhibitor, for Treatment of Mild to Moderate Primary Osteoarthritis of the Knee

Osteoarthritis Clinical Trial

Official title: A Phase Ia, Multicenter, Double-Blind, Placebo-controlled Study to Evaluate the Safety of CYT-108 for the Therapy of Mild to Moderate Primary Osteoarthritis of the Knee

Status Not yet recruiting

Clinical Trial Summary

The goal of this Phase 1 study is to investigate the safety of CYT-108, our experimental recombinant protease inhibitor drug candidate for osteoarthritis, in a population of patients suffering from osteoarthritis of the knee. The main questions this study aims to answer are:

1. are two doses of CYT-108, delivered 12 weeks apart, safe when injected directly into the joint?

2. does administration of CYT-108 result in a reduction in pain, stiffness, and improvement in daily physical function?

Participants will either receive a placebo (Phosphate Buffer Saline, PBS) or CYT-108, and will be asked to report their pain/stiffness at weeks 1, 4, 8, 12, 16, and 26 (in a physician's office) after the initial injection, using a questionnaire to be provided by the physician. In addition to reporting the magnitude of pain, participants will also be asked about the onset of pain reduction. Researchers will compare the pain/stiffness scores between the CYT-108-treated to placebo-treated groups along the 26 week duration of the study. Participants will also receive blood draws along the course of the study, and researchers will analyze this blood for the presence of cartilage degradation product in attempt to identify "disease modification" (i.e., a reduction in cartilage degradation) in response to CYT-108 treatment.

Clinical Trial Description

The Phase 1a trial will be a multicenter, double-blind, randomized, placebo-controlled clinical study to evaluate the safety of two doses of CYT-108 (given at Day 1 and Day 85) in participants with mild to moderate primary OA of the knee, followed out to 26 weeks. A Screening Visit will be performed between twenty-eight days to two days before the first dose, (i.e., Days -28 to -2), and if eligible, participants will attend baseline evaluation on Day 1 to confirm eligibility before randomization to treatment. The first and second doses will be administered on Day 1 and Day 85 (12 weeks post-first dose, with six follow-up visits on Days 8, 29, 57, 85, 113, and 183 (1, 4, 8, 12, 16, and 26 weeks post-first dose respectively).

At screening, each participant will undergo the informed consent process. After written informed consent is obtained, participants will undergo screening assessments to determine study eligibility. Participants who have not had an X-ray performed within 6 months of screening will undergo an X-ray to determine eligibility. After completing all assessments and meeting study eligibility, the participant will be randomized to receive active treatment or control. Assessments of OA symptoms (WOMAC) will be performed, and blood samples will be obtained at screening and the baseline visit pre-first dose (Day 1) and at specified time-points over the 26-week study period (Weeks 1, 4, 8, 12, 16, and 26).

Approximately twenty-two (22) participants will be randomized in this study in the following manner:

• Participants randomized to Active treatment (12 participants, to assure at least 10 participants to complete the study) will receive one, 5mL (five milliliters) intra-articular injections of CYT-108 (5mg/mL) on each Days 1 and 85, with arthrocentesis prior to injection if clinically appropriate at the time of intervention. Excess fluid in the participant's knee joint will be withdrawn before the drug injection and discarded.

• Participants randomized to Control treatment (10 participants) will receive one, 5mL intra-articular injections of PBS on each Days 1 and 85, with arthrocentesis prior to injection if clinically appropriate at the time of intervention. Excess fluid in the participant's knee joint will be withdrawn before the drug injection and discarded.

Following screening, all participants will have seven site visits on schedule starting with attending the site for the first injection on Day 1, with follow up visits at Weeks 1, 4, 8 and 12. The second injection will be administered at Week 12 after the Investigator has reviewed the participant and confirmed administration of the second dose is acceptable. After this second dose, follow-up evaluations will be conducted in Weeks 16, and 26. At each visit, patients will a combination of physical exams, blood draws, urinalysis, analysis of vital signs, and joint pain/stiffness assessment (using the WOMAC scoring system).

The Week 26 visit will be the end of the study visit (EOS). Participants who withdraw or are withdrawn after the first dose will be asked to attend at early termination visit (ET), at which EOS assessments will be performed. Self-provided rescue medication and any other concomitant medication will be recorded throughout the duration of the study by the study staff or via the participant's diary (ePRO). ;

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

• NCT number: NCT06263270
• Study type: Interventional
• Source: Cytonics Corporation
• Contact: Joey Bose, MS
• Phone: 4438278135
• Email: joey.bose@cytonics.com
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 1, 2024
• Completion date: December 31, 2024