Clinical trial NCT04044742: A Phase 3 Study to Evaluate the Efficacy and Safety of Resiniferatoxin for Pain Due to Osteoarthritis of the Knee
Official title: A Phase 3 Placebo-controlled Study to Evaluate the Efficacy and Safety of Intra-articular Administration of Resiniferatoxin Versus Placebo for the Treatment of Moderate to Severe Pain Due to Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Knee Pain Chronic
Lead sponsor: Sorrento Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-05
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
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 intra-articular injection of resiniferatoxin in patients with moderate to severe knee pain due to osteoarthritis.

Detailed description: This study is to evaluate the analgesic efficacy and safety of resiniferatoxin administered intra-articularly to subjects with moderate to severe knee pain due to osteoarthritis (OA).

Eligibility criteria: Key Inclusion Criteria:

* Male or female 35 to 85 years of age (inclusive).
* Diagnosis of moderate to severe pain in the index knee due to OA.
* Pain in the non-index knee is less than pain in the index knee.
* Body mass index ≤40 kg/m².
* Experienced treatment failure with at least 2 prior categories of therapies.
* Able to understand and complete study-related forms and communicate with the Investigator and/or site staff.

Key Exclusion Criteria:

* Evidence or history of a serious coagulopathy or hemostasis problem, such as inherited bleeding disorders or thrombocytopenia.
* History of or current condition of poorly controlled hypertension, QTc prolongation, history of risk factors for Torsades de Pointes, or family history of long QT syndrome; or is using concomitant medications that prolong the QT interval.
* Received index knee injections with corticosteroids within 30 days, or hyaluronic acid within 3 months, or platelet-rich plasma within 6 months prior to the injection day.
* Pre-existing osteonecrosis, subchondral insufficiency fracture, severe bone on bone OA, or knee pain attributable to disease other than OA.
* Instability or misalignment in the index knee.
* Concurrent use of opioids or indications other than knee pain.
* History within the past 2 years of substance abuse, including alcohol.
* Allergy or hypersensitivity to chili peppers, capsaicin, resiniferatoxin, acetaminophen, tramadol, or radiographic contrast agents.
* Female participants who are pregnant, planning on becoming pregnant, or currently breastfeeding.
* Any medical condition or comorbidities that, in the Investigator's opinion, could adversely impact study participation or safety, conduct of the study, or interfere with pain assessments.
* Sensory peripheral neuropathy that is of moderate severity or higher.
* Arterial or venous thrombi (including stroke), myocardial infarction, hospital admission for unstable angina, cardiac angioplasty, or stenting within the past 12 months.
* Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or hepatitis C. Participants with these viral infections who are receiving or have received antiviral treatment and have a viral load that is undetectable are eligible.
* Concurrent medical or arthritic conditions that could interfere with the evaluation of the index knee joint including chondromalacia patellae, metabolic diseases, gout/pseudogout, hemochromatosis, acromegaly, fibromyalgia, rheumatoid arthritis, or other inflammatory arthropathies affecting the knee joint.
* Undergone arthroscopic surgery of the index knee within 6 months of the injection day, or open surgery to the index knee within 24 months of the injection day.
* Undergone replacement surgery of the index knee.
* Presence of surgical hardware or other foreign bodies in the index knee.

Primary outcomes:
measure: Change in index knee pain with walking
timeFrame: Baseline through Week 12
Secondary outcomes:
measure: Area under the curve (AUC) change in average pain in the index knee
timeFrame: Baseline through Week 12
measure: Change in index knee pain with walking
timeFrame: Baseline through Week 26
measure: AUC change in average pain in the index knee
timeFrame: Baseline through Week 26
measure: Duration of effect of a single injection in the index knee
timeFrame: Baseline through return to Baseline
measure: Change in index knee pain, stiffness, and physical function
timeFrame: Baseline through Week 12, Week 26, and Week 52
measure: Change in the average pain in the index knee
timeFrame: Baseline through Week 12, Week 26, and Week 52
measure: Change in the average stiffness in the index knee
timeFrame: Baseline through Week 12, Week 26, and Week 52
measure: Change in the average function in the index knee
timeFrame: Baseline through Week 12, Week 26, and Week 52
measure: Change in index knee pain with walking
timeFrame: Baseline through Week 52
measure: AUC change in average pain in the index knee
timeFrame: Baseline through Week 52
measure: Change in quality of life (QOL) - SF-36 Health Survey
timeFrame: Baseline through Week 12, Week 26, and Week 52
measure: Change in quality of sleep
timeFrame: Baseline through Week 12, Week 26, and Week 52
measure: Patient Global Impression of Change
timeFrame: At Week 12, Week 26, and Week 52
measure: Change in QOL - EQ-5D-5L
timeFrame: Baseline through Week 12, Week 26, and Week 52
Other outcomes:
Locations:
Study officials:
affiliation: Sorrento Therapeutics, Inc.
name: Monica Luchi, MD
role: STUDY_DIRECTOR
References: