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PEP and Euflexxa for Osteoarthritis

Phase 1
Waitlist Available
Research Sponsored by Rion Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Daily knee pain in the more symptomatic knee of ≥ 30 and ≤ 80 on a 100-point VAS for greater than 6 months
Requesting injection therapy for pain management
Must not have
History of cancer including melanoma (with the exception of localized skin cancer) in the past 2 years
Systemic (oral, intravenous, or intramuscular) steroids in the last 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 365
Awards & highlights

Summary

This trial looks at the safety and effectiveness of injecting a substance called PEP, mixed with saline, directly into the knee joint at different doses to treat knee osteoarthritis. They also want to

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed here, typical reactions to intra-articular injections can include pain at the injection site, swelling, stiffness in the joint, headache, back pain or flu-like symptoms. The safety profile will be closely monitored throughout this Phase 1b trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had daily knee pain for over 6 months, scoring between 30 to 80 out of 100.
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I am seeking injection therapy for pain relief.
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My knee X-ray shows moderate to severe arthritis.
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I have had knee arthritis symptoms for at least 6 months.
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I am between 18 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had cancer, except for skin cancer, in the last 2 years.
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I haven't taken steroids by mouth, IV, or muscle in the last 3 months.
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I do not have severe nerve, heart, lung, or rheumatic diseases affecting my daily activities.
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I am HIV positive.
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I haven't had steroid or gel injections in my knee in the last 3 months.
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I am currently on a cancer treatment regimen.
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I am not pregnant, breastfeeding, or trying to become pregnant.
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I have not had cartilage restoration in my knee in the last 5 years.
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My HbA1c level is 8.0% or higher, indicating poorly controlled diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 365
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 365 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Long Term Safety Follow-Up Occurrence of DLTs From Day 91 to Day 365
Primary Safety Follow up 90 Days post injection occurrence of DLTs
Secondary outcome measures
Exploratory Endpoints of Efficacy-Participant-Reported responses
Exploratory Endpoints of Efficacy-Radiographic Response

Trial Design

4Treatment groups
Experimental Treatment
Group I: 2b PEP-EUFLEXXA High DoseExperimental Treatment1 Intervention
2B PEP-EUFLEXXA High Dose
Group II: 2a PEP-EUFLEXXA Low DoseExperimental Treatment1 Intervention
2A PEP-EUFLEXXA Low Dose
Group III: 1B PEP High DoseExperimental Treatment1 Intervention
1B PEP High Dose in Saline
Group IV: 1A PEP Low DoseExperimental Treatment1 Intervention
1A PEP Low Dose in Saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PEP
2019
N/A
~890

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Rion Inc.Lead Sponsor
2 Previous Clinical Trials
48 Total Patients Enrolled
Caidya Clinical Research OrganizationUNKNOWN
~16 spots leftby Nov 2025
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