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

NCT04044742 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: STI-RTX-3001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis, Knee; Knee Pain Chronic

Outcome Measures

Primary Outcomes (1)

• Change in index knee pain with walking

  Change in the weekly mean of Average Daily Pain (ADP) scores in the index knee, using the 10-point Numerical Pain Rating Scale (NPRS)

  Baseline through Week 12

Secondary Outcomes (14)

• Area under the curve (AUC) change in average pain in the index knee

  Baseline through Week 12

• Change in index knee pain with walking

  Baseline through Week 26

• AUC change in average pain in the index knee

  Baseline through Week 26

• Duration of effect of a single injection in the index knee

  Baseline through return to Baseline

• Change in index knee pain, stiffness, and physical function

  Baseline through Week 12, Week 26, and Week 52

Study Arms (2)

Resiniferatoxin

EXPERIMENTAL

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

Drug: Resiniferatoxin

Placebo

PLACEBO COMPARATOR

Placebo formulation in 5 mL volume administered intra-articularly

Drug: Placebo

Interventions

Resiniferatoxin DRUG

Receiving Resiniferatoxin injection

Also known as: RTX

Resiniferatoxin

Placebo DRUG

Receiving Placebo injection

Also known as: Diluent

Placebo

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

resiniferatoxin

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Monica Luchi, MD

  Sorrento Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The treatment assigned to each subject is blinded to the subject, investigators, and sponsor study team.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 5, 2019
• Study Start: December 1, 2020
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: November 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share