PEP and Euflexxa for Osteoarthritis

Overseen By Shariq Khan, M.S.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Rion Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

Evaluate the safety and exploratory efficacy of single intra-articular injections of PEP reconstituted with 0.9% Normal Saline at a low dose (one vial PEP) and high dose (two vials PEP), with and without EUFLEXXA, for the treatment of Knee Osteoarthritis

Eligibility Criteria

This trial is for individuals with knee osteoarthritis. Participants should be adults who are experiencing symptoms and have not found relief from other treatments. Details on specific inclusion or exclusion criteria are not provided, but typically these would outline the severity of osteoarthritis, age range, overall health status, and any medications or conditions that might interfere with the trial.

Inclusion Criteria

I have had daily knee pain for over 6 months, scoring between 30 to 80 out of 100.

I am seeking injection therapy for pain relief.

Ability to comply with protocol

Exclusion Criteria

I have not had a knee cleaning surgery in the last 6 months.

Concurrent participation in another investigational drug or device study or participation in the last 30 days prior to enrollment

I do not have severe nerve, heart, lung, or rheumatic diseases affecting my daily activities.

Treatment Details

Interventions

• PEP (Other)
• PEP/Euflexxa (Other)

Trial Overview The study is testing single intra-articular injections (directly into the knee joint) of a product called PEP at two different doses: low (one vial) and high (two vials). It's also looking at PEP combined with EUFLEXXA to see if they're safe and potentially effective in treating knee osteoarthritis.

Participant Groups

Group I: 2b PEP-EUFLEXXA High Dose Experimental Treatment 1 Intervention

2B PEP-EUFLEXXA High Dose

Group II: 2a PEP-EUFLEXXA Low Dose Experimental Treatment 1 Intervention

2A PEP-EUFLEXXA Low Dose

Group III: 1B PEP High Dose Experimental Treatment 1 Intervention

1B PEP High Dose in Saline

Group IV: 1A PEP Low Dose Experimental Treatment 1 Intervention

1A PEP Low Dose in Saline

Who Is Running the Clinical Trial?

Rion Inc.

Lead Sponsor

Trials

4

Recruited

260+

Caidya Clinical Research Organization

Collaborator

Trials

1

Recruited

20+