Phase 1b Open-Label, Multi-Center, Randomized Trial to Evaluate the Safety of PEP and EUFLEXXA for the Treatment of Subjects With Knee Osteoarthritis (KOA)

Rion Inc.

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

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).

Eligibility

Age range: 18–90 years
Sex: All
Healthy volunteers: Yes

Detailed 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…

Interventions

Combination Product
PEP/Euflexxa
Euflexxa (PMA: P010029)
Drug
PEP
PEP (Purified Exosome Product)

Location

Mayo Clinic in Rochester
Rochester, Minnesota