Clinical trial NCT04885972: Study to Evaluate Intra-articular Resiniferatoxin to Treat Moderate to Severe Pain From Knee Osteoarthritis
Official title: A Phase 2, Randomized, Active and Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of Intra-articular Resiniferatoxin to Treat Moderate to Severe Pain From Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Knee Osteoarthritis
Knee Pain Chronic
Keywords: osteoarthritis
knee pain
knee
Lead sponsor: Sorrento Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-13
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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..

Detailed description: This study is a multi-center, Phase 2, randomized, dose ranging, assessor-blinded, active and placebo-controlled, parallel-group prospective study evaluating 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.

A planned 112 subjects will be randomized to one of 7 groups (n=16 each) with each subject receiving one IA injection in the index knee joint (the knee primarily affected by pain if bilateral).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Worst Average Daily Pain at Week 26
timeFrame: Baseline to Week 26
Secondary outcomes:
measure: Duration of response
timeFrame: Baseline through end of study at Week 52
measure: Change in Worst Average Daily Pain at Week 12
timeFrame: Baseline to Week 12
measure: Change in quality of life
timeFrame: Baseline to Week 26
measure: Change in WOMAC score
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: La Mesa
country: United States
facility: Horizon Clinical Research
state: California
city: Pasadena
country: United States
facility: Lotus Clinical Research
state: California
city: Oak Brook
country: United States
facility: Affinity Health
state: Illinois
city: Edgewood
country: United States
facility: Advance Pain
state: Kentucky
city: Bellaire
country: United States
facility: HD Research LLC
state: Texas
city: Carrollton
country: United States
facility: HD Research LLC
state: Texas
Study officials:
affiliation: Sorrento Therapeutics, Inc.
name: Mike Royal, MD
role: STUDY_DIRECTOR
References: