Study of Resiniferatoxin for Knee Pain in Moderate to Severe Osteoarthritis

Phase 1

Completed

• Conditions: Osteoarthritis, Knee; Pain, Knee
• Interventions: Drug: Resiniferatoxin; Drug: Saline

• Registration Number: NCT03542838
• Lead Sponsor: Sorrento Therapeutics, Inc.

Brief Summary

This study evaluates the safety of resiniferatoxin in patients with moderate to severe knee pain due to osteoarthritis.

Detailed Description

This study is to evaluate the safety of resiniferatoxin administered intra-articularly to subjects with moderate to severe knee pain due to osteoarthritis (OA). It is also to assess the preliminary efficacy of resiniferatoxin to relieve knee pain when walking.

Study Timeline

• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-05-18
• Study First Posted: 2018-05-31
• Study Start: 2018-07-12
• Primary Completion: 2020-04-13
• Study Completion: 2021-02-11
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-30
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

Not provided

Exclusion Criteria

1. Has evidence or history of a coagulopathy or hemostasis problem at Screening or Baseline (Day 1)

2. Treatment knee injections with corticosteroids within 30 days or hyaluronic acid within 3 months prior to the procedure

3. If on opioid analgesics, an upper limit of 30 mg/day of oral morphine sulfate, 20 mg/day of oxycodone, 30 mg/day of hydrocodone, or 300 mg/day of tramadol, or equivalent

4. Any of the following lab abnormalities within one week of the treatment day:

   • Platelet count <100,000 cells/mm3
   • Total neutrophil count <1500 cells/mm3
   • Serum creatinine ≥ 1.5 x ULN
   • Alanine aminotransferase (ALT) > 3.0 x ULN
   • Aspartate aminotransferase (AST) > 3.0 x ULN
   • Alkaline phosphatase > 2.0 ULN
   • Bilirubin > 1.5 x ULN
   • INR > 1.5 x ULN
   • Temperature ≥ 100.4°F or other evidence of an infection

5. Concurrent use of opioids for indications other than knee pain

6. History of substance abuse

7. Has an allergy or hypersensitivity to chili peppers, capsaicin, resiniferatoxin or radiographic contrast agents

8. Female subjects who are pregnant at Screening or are planning on becoming pregnant, or are currently breastfeeding

9. Subjects with any medical condition or comorbidities that could adversely impact study participation or safety, conduct of the study, or interfere with pain assessments

10. Subjects who have participated in a clinical study of an investigational drug within 4 half-lives of Screening or are scheduled to receive and investigational agent while participating in this study

11. Sensory peripheral neuropathy that is CTCAE Grade 2 or higher at Screening

12. Arterial or venous thrombi, myocardial infarction, admission for unstable angina, cardiac angioplasty, or stenting within 12 months prior to Screening

13. Evidence or history of any hemorrhage or bleeding event that is higher than CTCAE Grade 1 within 4 weeks prior to injection.

14. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or C. Positive tests for HIV-1 or -2 antibodies, hepatitis B surface antigen, or hepatitis C antibodies.

15. Concurrent medical or arthritic conditions that could interfere with evaluation of the index knee joint including fibromyalgia, rheumatoid arthritis, or other inflammatory arthropathies affecting the knee joint

16. Subjects with significant pain in other joints may be excluded at the discretion of the investigator

17. Subject has undergone arthroscopic or open surgery to the knee within 6 months of the planned injection day

18. Subject has undergone replacement surgery of the treatment knee

19. Presence of surgical hardware or other foreign bodies in the treatment knee

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resiniferatoxin	Resiniferatoxin	Resiniferatoxin is administered as a one-time dose, intra-articularly at a dose level of 5ug, 12.5ug, 20ug, 25ug, or 30ug.
Saline	Saline	Saline is administered as a one-time dose, intra-articularly.

Primary Outcome Measures

Name	Time	Method
Safety measurement	baseline through week 52	Incidence and severity of adverse events

Secondary Outcome Measures

Name	Time	Method
Improvement of knee pain when walking	baseline through week 52	Improvement in pain score versus baseline using the WOMAC Osteoarthritis Index question A1 (pain on walking, 11-point numerical rating scale)

Trial Locations

Locations (4)

Snibbe Orthopedics; 🇺🇸 Los Angeles, California, United States

University of Miami/Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Hermann Drive Surgical Hospital; 🇺🇸 Houston, Texas, United States