Safety of Intra-Articular Sc-rAAV2.5IL-1Ra in Subjects With Moderate Knee OA

Phase 1

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: sc-rAAV2.5IL-1Ra

• Registration Number: NCT02790723
• Lead Sponsor: Mayo Clinic

Brief Summary

This study seeks to determine the safety of three different doses of sc-rAAV2.5IL-1Ra delivered by intra-articular injection into one knee joint of patients with moderate OA of the knee.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-31
• Study First Posted: 2016-06-06
• Study Start: 2019-06-05
• Primary Completion: 2022-03-17
• Study Completion: 2022-03-17
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-14
• Last Update Posted: 2022-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose Group	sc-rAAV2.5IL-1Ra	Subjects will receive a single intra-articular 2mL injection consisting of 10{11} viral genomes.
High Dose Group	sc-rAAV2.5IL-1Ra	Subjects will receive a single intra-articular 2mL injection consisting of 10{13} viral genomes.
Medium Dose Group	sc-rAAV2.5IL-1Ra	Subjects will receive a single intra-articular 2mL injection consisting of 10{12} viral genomes.

Primary Outcome Measures

Name	Time	Method
Number of subjects experiencing severe adverse events.	53 weeks	Assess the local and systemic safety of three different doses of sc-rAAV2.5IL-1Ra delivered by intra-articular injection into one knee joint of patients with moderate OA of the knee.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States