Study to Evaluate Resiniferatoxin in Patients With Knee Osteoarthritis Whose Total Knee Replacement Surgery is Delayed

NCT04386980 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: STI-RTX-3004
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Efficacy and safety study of resiniferatoxin versus placebo to manage pain in patients with knee osteoarthritis whose TKR surgery is delayed

Conditions

Osteoarthritis, Knee; Osteo Arthritis Knee; Knee Pain Chronic

Keywords

osteoarthritis; knee pain

Outcome Measures

Primary Outcomes (1)

• Change in WOMAC pain and function subscales combined score

  Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 3.1 numerical rating scale (NRS) \[0-10 scale\] Pain and Function combined score. The combined score ranges from 0 to 220; a higher score indicates greater severity of disease.

  Baseline to Week 12

Secondary Outcomes (4)

• Safety of RTX: Incidence and severity of adverse events

  Baseline through Week 12

• Change in analgesic usage

  Baseline to Week 4, Week 8, Week 12

• Change in WOMAC pain and function subscales combined score

  Baseline to Week 4, Week 8

• Patient Global Impression of Change (PGIC) in index knee pain

  Baseline to Week 4, Week 8, Week 12

Study Arms (2)

Resiniferatoxin

EXPERIMENTAL

12.5 ug of Resiniferatoxin in 5 mL volume administered once intra-articularly

Drug: Resiniferatoxin

Placebo

PLACEBO COMPARATOR

5 mL of diluent in normal saline administered once intra-articularly

Drug: Placebo

Interventions

Resiniferatoxin DRUG

Resiniferatoxin is a compound purified from natural sources.

Also known as: RTX

Resiniferatoxin

Placebo DRUG

Diluent in normal saline

Placebo

Eligibility Criteria

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

You may qualify if:

• Able to give informed consent and comply with the study
• Diagnosis of osteoarthritis (OA) in the index knee
• Combined WOMAC A (pain) and C (function) subscale score of ≥ 23 at screening, using the WOMAC 5-point Likert scale
• Eligible for total knee replacement (TKR) surgery but unable to schedule surgery or undergo scheduled surgery
• In good general health; American Society of Anesthesiologists (ASA) physical status category ≤3
• Willing to use contraception for at least 30 days after receiving the study drug
• Able to understand and complete study-related forms and adequately communicate with the Investigator and site staff

You may not qualify if:

• Pre-existing osteonecrosis, subchondral insufficiency fracture, or knee pain attributable to disease other than OA which may confound the ability to assess response to treatment
• Concurrent medical or arthritic conditions that could interfere with evaluation of the index knee joint including, metabolic diseases, gout/pseudogout, hemochromatosis, acromegaly, fibromyalgia, rheumatoid arthritis, or other inflammatory arthropathies affecting the knee joint
• Participants with significant pain in the back or other joints (ex. hip pain) which may confound discrimination of pain assessment in index knee, as judged by the Investigator
• Undergone arthroscopic surgery of the index knee within 6 months of study drug administration, or open surgery to the index knee within 24 months of study drug administration
• Undergone replacement surgery of the index knee
• Presence of surgical hardware or other foreign bodies in the index knee
• Index knee injections with corticosteroids within 30 days, or hyaluronic acid within 3 months, or platelet-rich plasma within 6 months prior to study drug administration.
• Concurrent use of opioids for indications other than knee pain
• Arterial or venous thrombi (including stroke), myocardial infarction, hospital admission for unstable angina, cardiac angioplasty, or stenting within 12 months prior to Screening.
• Sensory peripheral neuropathy in the distal aspect of the target limb that is of moderate severity or higher at Screening
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or hepatitis C; positive tests for HIV-1 or -2 antibodies, hepatitis B surface antigen, or hepatitis C antibodies
• Specified laboratory abnormalities within 1 week of study drug administration
• History within the past 2 years of substance abuse, including alcohol
• Allergy or hypersensitivity to chili peppers, capsaicin, resiniferatoxin, acetaminophen, tramadol, radiographic contrast agents, or any of the agents to be used for sedation, anesthesia or nerve block on the day of study drug administration
• Female participants who are pregnant, planning on becoming pregnant within 30 days of receiving study drug, or are breastfeeding at Screening

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

resiniferatoxin

Condition Hierarchy (Ancestors)

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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 13, 2020
• Study Start: April 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: November 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share