A Phase 3 Study to Evaluate the Efficacy and Safety of Resiniferatoxin for Pain Due to Osteoarthritis of the Knee

NCT ID: NCT04044742

Last Updated: 2021-11-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-31
• Study Completion Date: 2023-03-31

Brief Summary

This study evaluates the efficacy and safety of intra-articular injection of resiniferatoxin in patients with moderate to severe knee pain due to osteoarthritis.

Detailed Description

This study is to evaluate the analgesic efficacy and safety of resiniferatoxin administered intra-articularly to subjects with moderate to severe knee pain due to osteoarthritis (OA).

Conditions

Osteoarthritis, Knee; Knee Pain Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Resiniferatoxin

12.5 ug of Resiniferatoxin in 5 mL volume is administered as a one-time dose, intra-articularly

Group Type: EXPERIMENTAL

Resiniferatoxin

Intervention Type: DRUG

Receiving Resiniferatoxin injection

Placebo

Placebo formulation in 5 mL volume administered intra-articularly

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Receiving Placebo injection

Interventions

Resiniferatoxin

Receiving Resiniferatoxin injection

Intervention Type: DRUG

Placebo

Receiving Placebo injection

Intervention Type: DRUG

Other Intervention Names

RTX; Diluent

Eligibility Criteria

Inclusion Criteria

• Male or female 35 to 85 years of age (inclusive).
• Diagnosis of moderate to severe pain in the index knee due to OA.
• Pain in the non-index knee is less than pain in the index knee.
• Body mass index ≤40 kg/m².
• Experienced treatment failure with at least 2 prior categories of therapies.
• Able to understand and complete study-related forms and communicate with the Investigator and/or site staff.

Exclusion Criteria

• Evidence or history of a serious coagulopathy or hemostasis problem, such as inherited bleeding disorders or thrombocytopenia.
• History of or current condition of poorly controlled hypertension, QTc prolongation, history of risk factors for Torsades de Pointes, or family history of long QT syndrome; or is using concomitant medications that prolong the QT interval.
• Received index knee injections with corticosteroids within 30 days, or hyaluronic acid within 3 months, or platelet-rich plasma within 6 months prior to the injection day.
• Pre-existing osteonecrosis, subchondral insufficiency fracture, severe bone on bone OA, or knee pain attributable to disease other than OA.
• Instability or misalignment in the index knee.
• Concurrent use of opioids or indications other than knee pain.
• History within the past 2 years of substance abuse, including alcohol.
• Allergy or hypersensitivity to chili peppers, capsaicin, resiniferatoxin, acetaminophen, tramadol, or radiographic contrast agents.
• Female participants who are pregnant, planning on becoming pregnant, or currently breastfeeding.
• Any medical condition or comorbidities that, in the Investigator's opinion, could adversely impact study participation or safety, conduct of the study, or interfere with pain assessments.
• Sensory peripheral neuropathy that is of moderate severity or higher.
• Arterial or venous thrombi (including stroke), myocardial infarction, hospital admission for unstable angina, cardiac angioplasty, or stenting within the past 12 months.
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or hepatitis C. Participants with these viral infections who are receiving or have received antiviral treatment and have a viral load that is undetectable are eligible.
• Concurrent medical or arthritic conditions that could interfere with the evaluation of the index knee joint including chondromalacia patellae, metabolic diseases, gout/pseudogout, hemochromatosis, acromegaly, fibromyalgia, rheumatoid arthritis, or other inflammatory arthropathies affecting the knee joint.
• Undergone arthroscopic surgery of the index knee within 6 months of the injection day, or open surgery to the index knee within 24 months of the injection day.
• Undergone replacement surgery of the index knee.
• Presence of surgical hardware or other foreign bodies in the index knee.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sorrento Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monica Luchi, MD

Role: STUDY_DIRECTOR

Sorrento Therapeutics, Inc.

Other Identifiers

STI-RTX-3001

Identifier Type: -

Identifier Source: org_study_id