Study of OLP-1002 Injections for Reducing Moderate to Severe Pain Due to Osteoarthritis in Hip and/or Knee Joint

Osteoarthritis Clinical Trial

Official title: A 2-stage, Phase 2a Study to Evaluate the Efficacy, Safety, and Tolerability of OLP-1002 Subcutaneous Injections for Reducing Moderate to Severe Pain Due to Osteoarthritis in a Hip and/or Knee Joint

Status Completed

Clinical Trial Summary

The study is designed to evaluate the efficacy, safety and tolerability of OLP-1002 Subcutaneous (SC) injections for reducing moderate to severe pain due to osteoarthritis in a hip and/or knee joint.

Clinical Trial Description

The study consists of two Stages (Stage 1 and Stage 2)

Stage 1: It is an open-label, dose-finding study employing a single ascending dose design to determine appropriate dose level starting dose of OLP-1002 for Stage 2 of the study in participants with moderate to severe pain due to osteoarthritis in a hip and/or knee joint.

Stage 1 consists of following:

• Screening period: up to 15 days (± 2 days) (defined as Day -23 to -9)

• Washout period: 5 days (± 1 day) (defined as Day -8 to -4)

• Baseline period: 3 days (± 1 day) (defined as Day -3 to -1)

• Treatment period: 1 day (defined as Day 1): participants will be subcutaneously administered a single dose of OLP-1002 at the assigned dose level (1 μg, 3 μg, 10 μg, 25 μg, 50 μg, 80 μg)

• Follow-up period: 30 days (± 5 days) (defined as Day 2 to 30)

Approximately 30 participants will be enrolled in Stage 1 of the study

Stage 2: The study will be a double-blind, placebo-controlled, parallel-arm study of up to 2 selected single doses of OLP-1002 to evaluate the efficacy of OLP-1002 in the treatment of pain in participants with moderate to severe pain due to osteoarthritis in a knee or hip joint.

Dose levels for Stage 2 will be 1 μg and 2 μg of OLP-1002. Dose selection was based on the conclusions drawn from the internal efficacy data review analysis conducted by Sponsor from data collected in Stage 1 of the study.

Stage 2 consists of following:

• Screening Period: up to 14 days (± 2 days)

• Baseline Period: 3 days (± 1 day)

• Treatment: 1 day (± 2 days)

• Follow-up period: 42 days from last dose, D43 (± 5 days)

Approximately 90 participants will be enrolled in Stage 2 of the study ;

Related Conditions & MeSH terms

• Osteoarthritis

• NCT number: NCT05216341
• Study type: Interventional
• Source: OliPass Corporation
• Status: Completed
• Phase: Phase 2
• Start date: January 11, 2021
• Completion date: September 7, 2023