PEP and Euflexxa for Osteoarthritis

Overseen By Shariq Khan, M.S.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Rion Inc.

Must not be taking: Cancer treatments, Systemic steroids

Disqualifiers: Cancer, HIV, BMI > 40, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have had steroid or viscosupplement injections in the last 3 months, or PRP injections in the last 6 months, you may not be eligible to participate.

Is Euflexxa safe for treating osteoarthritis?

The FLEXX trial studied Euflexxa for knee osteoarthritis and found it to be safe over a 26-week period. ^{1 2 3 4 5}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intra-articular injection of PEP, with or without EUFLEXXA, at low or high doses

1 day

1 visit (in-person)

Primary Safety Follow-up

Participants are monitored for safety through the occurrence of DLTs for 90 days post-injection

90 days

Long Term Safety Follow-up

Participants are monitored for long-term safety from Day 91 to Day 365 post-injection

275 days

Treatment Details

Interventions

• PEP
• PEP/Euflexxa

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+

Findings from Research

Etanercept is effective in treating juvenile idiopathic arthritis (JIA) categories such as extended oligoarthritis, enthesitis-related arthritis, and psoriatic arthritis, showing significant improvement in disease activity scores over 3 to 24 months in a study of 1,678 patients.

While etanercept is generally safe, there is an increased risk of serious and non-serious adverse events, particularly uveitis flares and reports of chronic inflammatory bowel disease in patients with these JIA categories, indicating the need for careful monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of etanercept in children with the JIA categories extended oligoarthritis, enthesitis-related arthritis and psoriasis arthritis. Windschall, D., Müller, T., Becker, I., et al.[2021]

Celecoxib is associated with a slightly increased risk of certain adverse events, such as edema, hypertension, angioedema, and allergic reactions compared to placebo, but these risks are relatively small.

In contrast, celecoxib shows a lower risk of gastrointestinal issues like hemorrhage and ulceration compared to non-selective NSAIDs, suggesting it may be a safer option for patients concerned about GI side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of celecoxib compared with placebo and non-selective NSAIDs: cumulative meta-analysis of 89 randomized controlled trials. Essex, MN., Zhang, RY., Berger, MF., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A double-blind, randomized, saline-controlled study of the efficacy and safety of EUFLEXXA for treatment of painful osteoarthritis of the knee, with an open-label safety extension (the FLEXX trial). [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Safety and efficacy of etanercept in children with the JIA categories extended oligoarthritis, enthesitis-related arthritis and psoriasis arthritis. [2021]

3. England pubmed.ncbi.nlm.nih.gov

The German etanercept registry for treatment of juvenile idiopathic arthritis. [2018]

4. Turkey pubmed.ncbi.nlm.nih.gov

A single-arm, open-label study to assess the immunogenicity, safety, and efficacy of etanercept manufactured using the serum-free, high-capacity manufacturing process administered to patients with rheumatoid arthritis. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Safety of celecoxib compared with placebo and non-selective NSAIDs: cumulative meta-analysis of 89 randomized controlled trials. [2022]