Study to Evaluate Intra-articular Resiniferatoxin to Treat Moderate to Severe Pain From Knee Osteoarthritis

Recruiting at 5 trial locations

Overseen By Mike Royal, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sorrento Therapeutics, Inc.

Must not be taking: Opioids, others

Disqualifiers: Hemorrhagic events, Coagulopathy, Surgery, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 53

Duration: 1 day

124 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing different doses of two drugs, RTX and Zilretta, to see which is best at reducing knee pain from osteoarthritis. The study involves people who have moderate to severe knee pain. The drugs are injected directly into the knee joint to help relieve pain. RTX is derived from cactus-like plants, and Zilretta is designed to provide long-lasting pain relief.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on any pain medications, you should have been on a stable dose for at least one month before the study and can continue 'as needed' pain medications during the study.

How is the drug Resiniferatoxin (RTX) unique compared to other treatments?

Resiniferatoxin (RTX) is unique because it targets and desensitizes specific nerve fibers (C-fibers) that are involved in pain and overactivity, unlike other treatments that may not be as selective. It works by activating a receptor called TRPV1, which can lead to the destruction of pain-sensing neurons, providing relief from conditions like neuropathic pain and detrusor overactivity. ^{1 2 3 4 5}

What data supports the effectiveness of the drug Resiniferatoxin (RTX) for treating lower urinary tract symptoms?

A meta-analysis suggests that Resiniferatoxin (RTX) may help treat storage lower urinary tract symptoms in patients with interstitial cystitis or detrusor overactivity, although its clinical efficiency hasn't been fully evaluated. ^{6 7 8 9 10}

Who Is on the Research Team?

Mike Royal, MD

Principal Investigator

Sorrento Therapeutics, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

BMI < 50 kg/m

Willing to follow contraception guidelines

You have significant knee pain caused by osteoarthritis, as determined by your doctor using specific guidelines from the American College of Rheumatology.

Exclusion Criteria

Have evidence of or history of a serious coagulopathy or hemostasis problem at Screening or Baseline

Have had an IA injection in the index knee within one month prior to screening (3 months if prior IA injection with Zilretta)

If on opioid analgesics to treat knee OA, have an upper limit of 30 mg/day as converted to an oral morphine equivalent dose

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intra-articular injection of either Resiniferatoxin, Zilretta, or placebo in the index knee joint

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

Multiple visits (in-person and virtual) over 52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Resiniferatoxin
• Zilretta

How Is the Trial Designed?

Group I: Resiniferatoxin Experimental Treatment 1 Intervention

7.5 mcg, 10 mcg, 12.5 mcg, 15 mcg, or 20 mcg in 5 mL injected once intra-articularly

Group II: Zilretta Active Control 1 Intervention

32 mg in 5 mL injected once intra-articularly

Group III: Placebo Placebo Group 1 Intervention

5 mL injected once intra-articularly

Who Is Running the Clinical Trial?

Sorrento Therapeutics, Inc.

Lead Sponsor

Trials

48

Recruited

2,000+

Published Research Related to This Trial

Resiniferatoxin (RTX) selectively ablates nociceptive neurons expressing the vanilloid receptor 1 (VR1), effectively reducing high-intensity pain perception and neurogenic inflammation in Rhesus monkeys without affecting normal touch sensation or motor function.

The study demonstrated that RTX infusion into the trigeminal ganglia led to significant reductions in pain responses (e.g., eye blinks and squinting) while showing no neurological deficits or toxicity, suggesting its potential as a treatment for pain syndromes like trigeminal neuralgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective ablation of nociceptive neurons for elimination of hyperalgesia and neurogenic inflammation. Tender, GC., Walbridge, S., Olah, Z., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Intravesical resiniferatoxin for the treatment of storage lower urinary tract symptoms in patients with either interstitial cystitis or detrusor overactivity: a meta-analysis. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

Effectiveness of a Second Biologic After Failure of a Non-tumor Necrosis Factor Inhibitor As First Biologic in Rheumatoid Arthritis. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Serious infection risk after 1 year between patients with rheumatoid arthritis treated with rituximab or with a second TNFi after initial TNFi failure: results from The British Society for Rheumatology Biologics Register for Rheumatoid Arthritis. [2018]

4. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Rituximab (RTX) as an Alternative to TNF-Alpha Antagonists in Patients with Rheumatoid Arthritis and High Risk of Severe Infections: A Systematic Analysis of the Experience in One Center. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Variability of rituximab and tocilizumab trough concentrations in patients with rheumatoid arthritis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The effect of epidural resiniferatoxin in the neuropathic pain rat model. [2012]

7. Australia pubmed.ncbi.nlm.nih.gov

Intravesical resiniferatoxin for patients with neurogenic detrusor overactivity. [2012]

8. England pubmed.ncbi.nlm.nih.gov

The preventive effect of resiniferatoxin on the development of cold hypersensitivity induced by spinal nerve ligation: involvement of TRPM8. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Selective ablation of nociceptive neurons for elimination of hyperalgesia and neurogenic inflammation. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Role of C afferent fibers and monitoring of intravesical resiniferatoxin therapy for patients with idiopathic detrusor overactivity. [2012]