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A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects

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ClinicalTrials.gov Identifier: NCT02536833
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Samumed LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: SM04690 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 455 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 9, 2015
Actual Primary Completion Date : April 20, 2017
Actual Study Completion Date : April 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: SM04690, 0.03mg/2mL
Single intra-articular injection of SM04690
Drug: SM04690
Experimental: SM04690, 0.07mg/2mL
Single intra-articular injection of SM04690
Drug: SM04690
Experimental: SM04690, 0.23mg/2mL
Single intra-articular injection of SM04690
Drug: SM04690
Placebo Comparator: Placebo
Single intra-articular injection of placebo
Drug: Placebo



Primary Outcome Measures :
  1. Change from baseline OA pain in the target knee [ Time Frame: Baseline and Week 13 ]
    Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscore at Week 13. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of patients with OA of the knee and hip, including pain, stiffness, and physical functioning of the joints.

  2. Change from baseline OA function in the target knee [ Time Frame: Baseline and Week 13 ]
    Change from baseline OA function in the target knee as assessed by the WOMAC function subscore at Week 13

  3. Change from baseline OA disease activity assessed by the patient [ Time Frame: Baseline and Week 13 ]
    Change from baseline OA disease activity as assessed by the Patient Global Assessment at Week 13


Secondary Outcome Measures :
  1. 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 in WOMAC total score for the target knee at Weeks 4, 13, 26, 39 and 52

  2. Change from baseline OA pain in the target knee [ Time Frame: Baseline and Weeks 4, 26, 39 and 52 ]
    Change from baseline OA pain in the target knee as assessed by the WOMAC pain subscore at Weeks 4, 26, 39 and 52

  3. Change from baseline OA function in the target knee [ Time Frame: Baseline and Weeks 4, 26, 39 and 52 ]
    Change from baseline OA function in the target knee as assessed by the WOMAC function subscore at Weeks 4, 26, 39 and 52

  4. Change from baseline OA disease activity as assessed by the patient [ Time Frame: Baseline and Weeks 4, 26, 39 and 52 ]
    Change from baseline OA disease activity as assessed by the Patient Global Assessment at Weeks 4, 26, 39 and 52

  5. Change from baseline in joint space width (JSW) of target knee [ Time Frame: Baseline and Weeks 26 and 52 ]
    Change from baseline in JSW as documented by X-ray of the target knee at Weeks 26 and 52

  6. 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 ]
    Percentage of OMERACT-OARSI "strict" responders at Weeks 13, 26, and 52. OMERACT-OARSI "strict" responders are defined as subjects experiencing a ≥50% improvement in pain or function with a corresponding ≥20 point change (using 100 point scale)

  7. Change from baseline health-related quality of life (HRQOL) [ Time Frame: Baseline and Weeks 4, 13, 26, 39 and 52 ]
    Change from baseline HRQOL as assessed by the 36-Item Short Form Health Survey (SF-36) at Weeks 4, 13, 26, 39 and 52

  8. Change from baseline OA disease activity as assessed by the physician [ Time Frame: Baseline and Weeks 4, 13, 26, 39 and 52 ]
    Change from baseline OA disease activity as assessed by the Physician Global Assessment at Weeks 4, 13, 26, 39 and 52



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536833


  Show 35 Study Locations
Sponsors and Collaborators
Samumed LLC
Investigators
Study Director: Yusuf Yazici, M.D. Samumed LLC

Responsible Party: Samumed LLC
ClinicalTrials.gov Identifier: NCT02536833     History of Changes
Other Study ID Numbers: SM04690-OA-02
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018

Keywords provided by Samumed LLC:
OA
Samumed

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases