Overview

This trial is active, not recruiting.

Condition osteoarthritis
Treatments sm04690, placebo
Phase phase 2
Sponsor Samumed LLC
Start date August 2015
End date April 2017
Trial size 445 participants
Trial identifier NCT02536833, SM04690-OA-02

Summary

The purpose of this study is to assess the efficacy, safety, and tolerability of three different strengths of SM04690 injected in the target knee joint of moderately to severely symptomatic osteoarthritis subjects.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Single intra-articular injection of SM04690
sm04690
(Experimental)
Single intra-articular injection of SM04690
sm04690
(Experimental)
Single intra-articular injection of SM04690
sm04690
(Placebo Comparator)
Single intra-articular injection of placebo
placebo

Primary Outcomes

Measure
Change from baseline OA pain in the target knee
time frame: Baseline and Week 13
Change from baseline OA function in the target knee
time frame: Baseline and Week 13
Change from baseline OA disease activity assessed by the patient
time frame: Baseline and Week 13

Secondary Outcomes

Measure
Change from baseline in WOMAC total score for the target knee
time frame: Baseline and Weeks 4, 13, 26, 39 and 52
Change from baseline OA pain in the target knee
time frame: Baseline and Weeks 4, 26, 39 and 52
Change from baseline OA function in the target knee
time frame: Baseline and Weeks 4, 26, 39 and 52
Change from baseline OA disease activity as assessed by the patient
time frame: Baseline and Weeks 4, 26, 39 and 52
Change from baseline in joint space width (JSW) of target knee
time frame: Baseline and Weeks 26 and 52
Percentage of Outcome Measures in Rheumatology Clinical Trials (OMERACT)-Osteoarthritis Research Society International (OARSI) "strict" responders
time frame: Baseline and Weeks 13, 26 and 52
Change from baseline health-related quality of life (HRQOL)
time frame: Baseline and Weeks 4, 13, 26, 39 and 52
Change from baseline OA disease activity as assessed by the physician
time frame: Baseline and Weeks 4, 13, 26, 39 and 52

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

Inclusion Criteria: - Established diagnosis of primary femorotibial OA in the target knee for at least 6 months (clinical and radiographic [x-ray] criteria) - Radiographic [x-ray] disease Stage 2 or 3 in the target knee according to the Kellgren-Lawrence grading of knee OA - Screening pain visual analog scale (VAS) score in the required range for the target knee while on oral symptomatic treatment (if required) at study start - Total WOMAC score in the required range for the target knee while on symptomatic oral treatment (if required) at study start - Willingness to omit the following for 24 hours prior to all Study Visits, excluding the Screening Visit: 1. Pain medications 2. Medications or supplements for the treatment of OA 3. Participation in a formalized in-office and/or supervised OA disease program (e.g., a prescribed patient education program, physiotherapy, etc.) - Full understanding of the requirements of the study and willingness to comply with all study visits and assessments Exclusion Criteria: - Women who are pregnant or lactating - Women of childbearing potential (i.e., who are not surgically sterile or postmenopausal as defined by no menstrual periods for 12 consecutive months and no other biological or physiological cause for amenorrhea can be identified); males who are sexually active and have a partner who is capable of becoming pregnant, neither of which have had surgery to become sterilized, who are not using an effective method of birth control (e.g., surgically-implanted hormonal therapy, intrauterine devices or oral birth control with barrier method) - Body mass index (BMI) >40 - Partial or complete joint replacement in the target knee - Previous exposure to SM04690 - Major surgery (e.g., interventional arthroscopy) in the target knee within 12 months prior to any study injection - Any planned or elective surgery during the study period - Significant and clinically evident misalignment of the target knee, as determined by the Investigator - History of malignancy within the last 5 years; however, subjects with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Subjects with other malignancies are eligible if they have been continuously disease free for at least 5 years prior to any study injection - Comorbid conditions that could affect pain assessment of the target knee, including, but not limited to, inflammatory rheumatic conditions such as rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, diabetic neuropathy, pseudogout, gout, and fibromyalgia - Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure within 12 weeks prior to any study injection - Treatment of the target knee with systemic or intra-articular corticosteroids (e.g., methylprednisolone) within 2 months prior to study start - Viscosupplementation (e.g., hyaluronic acid) in the target knee within 6 months prior to study start - Effusion of the target knee requiring aspiration within 3 months prior to study start - Use of electrotherapy or acupuncture for OA within 4 weeks prior to study start - Any known active infections, including suspicion of intra-articular infection, hepatitis B or hepatitis C infection, and/or infections that may compromise the immune system such as human immunodeficiency virus (HIV) - Subjects taking prescription medications for OA who have not maintained a stable therapeutic regimen for a minimum of 3 months prior to study start - Subjects requiring the chronic use of the following medications: 1. Opioids, both oral (e.g., tramadol) and transdermal (e.g., fentanyl patches) formulations 2. Centrally acting analgesics (e.g., duloxetine) 3. Glucocorticoids (e.g., methylprednisolone) administered by any route, with exception of intranasal and ophthalmic solutions - Any chronic condition that has not been well controlled or subjects with a chronic condition who have not maintained a stable therapeutic regimen of a prescription therapy for a minimum of 3 months prior to study start

Additional Information

Official title A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Samumed LLC.