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

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Osteoarthritis, Knee, Knee Osteoarthritis, Knee Pain Chronic

In brief

This study evaluates the efficacy and safety of a single IA injection of various RTX doses, Zilretta or placebo for the treatment of pain due to moderate to severe osteoarthritis knee pain..

Key facts

Study ID: NCT04885972
Run by: Sorrento Therapeutics, Inc.
People needed: 124
Starts: 2021-11-15
Expected to finish: 2023-11-01
Last updated by the study team: 2023-01-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

BMI < 50 kg/m
Have moderate-to-severe pain in the index knee due to osteoarthritis (OA) as assessed by the investigator, based on American College of Rheumatology criteria
Have had OA pain duration in the index knee ≥ 6 months prior to Screening
Reports worst daily average pain with walking of ≥ 4 on the 0 to 10 NRS for pain intensity during the week prior to Screening
Have a knee x-ray or MRI scan with KL grade ≥ 2 in the index knee based upon radiographic images obtained within 3 months prior to Screening (image must be available for review)
Have had treatment failure with at least two prior analgesic agents (at least one NSAID) defined as discontinuation due to side effects or inadequate response to treatment
Willing to abstain from other IA injections or knee surgery for at least 6 months after study treatment unless elects early discontinuation from the study
Able to comply with the study procedures and give informed consent
If on any analgesic medications, have been taking a stable dose for at least one month prior to screening with no increase in dose leading up to study treatment. Note that if the subject is on "as needed" or PRN analgesic medications, these may be continued during the study
Willing to follow contraception guidelines

You may not qualify if…

Have a history of a hemorrhagic event that is CTCAEv5 Grade 2 or higher within the 6 months prior to screening
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)
Have undergone arthroscopic or open surgery or replacement surgery to the index knee within 6 months of screening
Have surgical hardware or other foreign bodies within the index knee joint
Have current instability/misalignment in the index knee post repair
Have a sensory peripheral neuropathy that is CTCAEv5 Grade 2 or higher involving the index leg at Screening
Have significant pain in other joints or body locations that make it difficult to assess pain in the index knee
If on opioid analgesics to treat knee OA, have an upper limit of 30 mg/day as converted to an oral morphine equivalent dose
Have a history of substance abuse
Have an allergy or hypersensitivity to capsaicin, chili peppers, lidocaine or resiniferatoxin
Pregnant at Screening or planning on becoming pregnant or currently breastfeeding
Have had a non-study related minor surgical procedure ≤ 3 days or major surgical procedure ≤ 14 days prior to Screening and must be sufficiently recovered and stable prior to study treatment
Have any medical condition or medical comorbidities that, in the Investigator's opinion, could adversely impact study participation or safety, conduct of the study, or interfere with pain assessments

Where it is running

Horizon Clinical Research — La Mesa, California, United States
Lotus Clinical Research — Pasadena, California, United States
Affinity Health — Oak Brook, Illinois, United States
Advance Pain — Edgewood, Kentucky, United States
HD Research LLC — Bellaire, Texas, United States
HD Research LLC — Carrollton, Texas, United States

Full record on ClinicalTrials.gov

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