Phase 1b Clinical Trial to Evaluate PEP and EUFLEXXA for Knee Osteoarthritis (KOA)

NCT ID: NCT06463132

Last Updated: 2024-06-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-11-01

Brief Summary

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

Detailed Description

Study Plan (with Dose Escalation): Arm 1 and Arm 2 will run in parallel such that initially 3 subjects will be enrolled in Arm 1a (PEP Low Dose) and 3 subjects will be enrolled in Arm 2a (PEP-EUFLEXXA Low Dose). After all 6 subjects complete the 30 day follow up and there was not more than 1 AE grade 3 or higher per Arm, a further 9 subjects will be enrolled in Arm 1b (PEP High Dose) and a further 9 subjects will be enrolled in Arm 2b (PEP-EUFLEXXA High Dose).

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1A PEP Low Dose

1A PEP Low Dose in Saline

Group Type: EXPERIMENTAL

PEP

Intervention Type: DRUG

PEP (Purified Exosome Product)

1B PEP High Dose

1B PEP High Dose in Saline

Group Type: EXPERIMENTAL

PEP

Intervention Type: DRUG

PEP (Purified Exosome Product)

2a PEP-EUFLEXXA Low Dose

2A PEP-EUFLEXXA Low Dose

Group Type: EXPERIMENTAL

PEP/Euflexxa

Intervention Type: COMBINATION_PRODUCT

Euflexxa (PMA: P010029)

2b PEP-EUFLEXXA High Dose

2B PEP-EUFLEXXA High Dose

Group Type: EXPERIMENTAL

PEP/Euflexxa

Intervention Type: COMBINATION_PRODUCT

Euflexxa (PMA: P010029)

Interventions

PEP/Euflexxa

Euflexxa (PMA: P010029)

Intervention Type: COMBINATION_PRODUCT

PEP

PEP (Purified Exosome Product)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age: Adults aged 18-90 years of age

Type of Participant and Disease Characteristics:

• Diagnosis of unilateral or bilateral symptomatic KOA of at least 6 months duration (meets American College of Rheumatology/Arthritis [ACR] criteria)
• Daily knee pain in the more symptomatic knee of ≥ 30 and ≤ 80 on a 100-point VAS for greater than 6 months
• Kellgren Lawrence Grade 2 to 3 osteoarthritis in the more symptomatic knee based on standard knee radiographs
• Failed conservative management including at least 2 of the following:
• Lack of improvement with attempted weight loss in the past year if body mass index (BMI) > 30 kg/m2;
• Lack of response to a 4-week trial in the past year of oral acetaminophen or NSAIDs taken as needed;
• Lack of response to a 4-week trial in the past year of topical NSAIDs or capsaicin applied as needed;
• Lack of improvement after injection therapy with cortisone, PRP or hyaluronic acid;
• Lack of improvement after a 4-week course of physical therapy in the past year; or
• Lack of improvement after a 4-week trial of quadriceps strengthening home exercise program in the past year.
• Requesting injection therapy for pain management
• Contraceptive use by participants and their partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria

• Signed informed consent as described in Appendix 1 (Section 10.1) which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Ability to comply with protocol.

• Steroid or viscosupplement injection in the planned treatment knee(s) within the past 3 months.
• PRP injection in the planned treatment knee(s) within the past 6 months.
• History of documented allergy to intra-articular EUFLEXXA.
• History of cancer including melanoma (with the exception of localized skin cancer) in the past 2 years.
• HIV positive participants.
• BMI > 40 kg/m2.
• Arthroscopic debridement in the planned treatment knee(s) in the last 6 months.
• Cartilage restoration procedure in the planned treatment knee(s) in the last 5 years.
• History of gout or pseudogout.
• History of or evidence of active rheumatologic disease, severe peripheral neuropathy, clinically evident cardiac or respiratory disease that interferes with functional status.
• Poorly controlled diabetes defined as a glycated hemoglobin (HbA1c) concentration of ≥ 8.0%.
• Currently taking any cancer treatment regimen (including aromatase inhibitors).
• Calcium pyrophosphate deposition disease (CPPD) evident on X-ray.
• Systemic (oral, intravenous, or intramuscular) steroids in the last 3 months.
• Concurrent participation in another investigational drug or device study or participation in the last 30 days prior to enrollment.
• Evidence of recent alcohol or drug abuse, or history of medication misuse or addiction.
• Female participants who are pregnant, breast feeding, or trying to become pregnant.
• Women unwilling to use approved contraception method for 3 months after receiving dose of investigational drug.
• Unwilling or unable to comply with Telehealth visits (eg, ability to access internet, on camera capabilities, etc).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Caidya Clinical Research Organization

UNKNOWN

Sponsor Role: collaborator

Rion Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Central Contacts

Shariq Khan, M.S.

Role: CONTACT

khan@riontx.com

847-702-4063

Maureen Merrifield, Ph.D.

Role: CONTACT

merrifield@riontx.com

2819146228

Other Identifiers

PRO-00126

Identifier Type: -

Identifier Source: org_study_id