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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02536833
Recruitment Status : Completed
First Posted : September 1, 2015
Results First Posted : September 15, 2020
Last Update Posted : September 15, 2020
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 (OA) subjects.

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

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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: 0.03 mg SM04690
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
Drug: SM04690
Experimental: 0.07 mg SM04690
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
Drug: SM04690
Experimental: 0.23 mg SM04690
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
Drug: SM04690
Placebo Comparator: Placebo
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
Drug: Placebo



Primary Outcome Measures :
  1. Change From Baseline Osteoarthritis (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) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 13. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore is reported ranging from 0 to 100.


Secondary Outcome Measures :
  1. Change From Baseline OA Pain in the Target Knee [ Time Frame: Baseline and Week 26 ]
    Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 26. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore is reported ranging from 0 to 100.

  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 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function) at Week 13. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore is reported ranging from 0 to 100.

  3. Change From Baseline OA Function in the Target Knee [ Time Frame: Baseline and Week 26 ]
    Change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function) at Week 26. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore is reported ranging from 0 to 100.

  4. Change From Baseline OA Disease Activity as 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. The Patient Global Assessment was completed using a 100 mm visual analog scale (VAS) adapted from the Patient Assessment Form © 1999, American College of Rheumatology. The subject rated how well he/she was doing, considering all the ways in which illness and health conditions may affected him/her. The VAS scale was anchored by "Very Well" on the left (scored as 0) and "Very Poorly" on the right (scored as 100). Higher scores indicated poorer disease assessment by the subject.

  5. Change From Baseline OA Disease Activity as Assessed by the Patient [ Time Frame: Baseline and Week 26 ]
    Change from baseline OA disease activity as assessed by the Patient Global Assessment at Week 26. The Patient Global Assessment was completed using a 100 mm visual analog scale (VAS) adapted from the Patient Assessment Form © 1999, American College of Rheumatology. The subject rated how well he/she was doing, considering all the ways in which illness and health conditions may affected him/her. The VAS scale was anchored by "Very Well" on the left (scored as 0) and "Very Poorly" on the right (scored as 100). Higher scores indicated poorer disease assessment by the subject.

  6. Change From Baseline in Medial Joint Space Width of Target Knee [ Time Frame: Baseline and Week 26 ]
    Change from baseline in medial joint space width as documented by X-ray of the target knee at Week 26.


Other Outcome Measures:
  1. Change From Baseline OA Pain in the Target Knee [ Time Frame: Baseline and Week 52 ]
    Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 52. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore is reported ranging from 0 to 100.

  2. Change From Baseline OA Function in the Target Knee [ Time Frame: Baseline and Week 52 ]
    Change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function) at Week 52. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore is reported ranging from 0 to 100.

  3. Change From Baseline in Medial Joint Space Width of Target Knee [ Time Frame: Baseline and Week 52 ]
    Change from baseline in medial joint space width as documented by X-ray of the target knee at Week 52.

  4. Change From Baseline OA Pain in the Target Knee [Unilateral Symptomatic OA] [ Time Frame: Baseline and Week 52 ]
    Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 52. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore is reported ranging from 0 to 100.

  5. Change From Baseline OA Function in the Target Knee [Unilateral Symptomatic OA] [ Time Frame: Baseline and Week 52 ]
    Change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function) at Week 52. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore is reported ranging from 0 to 100.

  6. Change From Baseline in Medial Joint Space Width of Target Knee [Unilateral Symptomatic OA] [ Time Frame: Baseline and Week 52 ]
    Change from baseline in medial joint space width as documented by X-ray of the target knee at Week 52.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  1. Males and females between 40 and 80 years of age, inclusive, in general good health
  2. Ambulatory (single assistive devices such as canes allowed if needed less than 50% of the time, subjects requiring a walker are excluded)
  3. Established diagnosis of primary femorotibial OA in the target knee by standard American College of Rheumatology (ACR) criteria for at least 6 months (clinical AND radiographic criteria); if bilateral knee OA is present, the target knee is defined as the knee with greater pain at screening based on the subject's evaluation and the Investigator's clinical judgment
  4. Radiographic disease Stage 2 or 3 in the target knee according to the Kellgren-Lawrence grading of knee OA as assessed by independent central readers
  5. Screening pain visual analog scale (VAS) score of 30-80 mm (on a scale of 0-100 mm) for the target knee while on symptomatic oral treatment at screening (if the subject requires oral treatment)
  6. Total WOMAC score of 72-192 (out of 240) for the target knee while on symptomatic oral treatment at screening (if the subject requires oral treatment)
  7. 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.)
  8. Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
  9. Subjects must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed
  10. Subject's Day 1 visit must occur while enrollment into the study is open

Exclusion Criteria:

  1. Women who are pregnant or lactating
  2. 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)
  3. Body mass index (BMI) >40
  4. Partial or complete joint replacement in the target knee
  5. Previous exposure to SM04690
  6. Major surgery (e.g., interventional arthroscopy) in the target knee within 52 weeks prior to any study injection
  7. Any planned or elective surgery during the study period
  8. Significant and clinically evident misalignment of the target knee that would impact subject function, as determined by the Investigator
  9. 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
  10. Clinically significant abnormal Screening Visit hematology values, blood chemistry values, HbA1c, or urinalysis values as determined by the investigator
  11. Any condition, including laboratory findings (not included in the Screening Visit laboratory tests) and findings in the medical history or in the pre-study assessments, that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
  12. 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
  13. Other conditions that, in the opinion of the Investigator, could affect pain assessment of the target knee, including, but not limited to, symptomatic hip osteoarthritis and symptomatic degenerative disc disease
  14. Any diagnosed psychiatric condition that includes, but is not limited to, a history of mania, bipolar disorder, psychotic disorder, schizophrenia, major depressive disorder, or generalized anxiety disorder
  15. 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; the last date of participation in the trial, not the last date of receipt of investigational product, must be at least 12 weeks prior to Study Visit Day 1
  16. Treatment of the target knee with systemic or intra-articular corticosteroids (e.g., methylprednisolone) within 8 weeks prior to Study Visit Day 1
  17. Viscosupplementation (e.g., hyaluronic acid) in the target knee within 24 weeks prior to Study Visit Day 1
  18. Effusion of the target knee clinically requiring aspiration within 12 weeks prior to Study Visit Day 1
  19. Use of electrotherapy, acupuncture, and/or chiropractic treatments for knee OA within 4 weeks prior to Study Visit Day 1
  20. 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)
  21. Subjects taking prescription medications for OA who have not maintained a stable therapeutic regimen for a minimum of 12 weeks prior to Study Visit Day 1
  22. Subjects requiring the chronic use (i.e., regular and consistent use for ≥ 12 weeks) of the medications listed below within 12 weeks prior to Study Visit Day 1:

    1. Opioids, both oral (e.g., tramadol) or 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 inhaled, intranasal, and ophthalmic solutions
  23. 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 12 weeks prior to Study Visit Day 1. In addition, the following subjects will be excluded:

    1. Subjects with a baseline HbA1c >9
    2. Subjects with uncontrolled hypertension in the opinion of the investigator
    3. Subjects with symptomatic coronary artery disease in the opinion of the investigator
  24. Subjects who have a current or pending disability claim, workers' compensation, or litigation(s) that may compromise response to treatment
  25. Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the investigative site, or are directly affiliated with the study at the investigative site
  26. Subjects employed by Samumed, LLC, or any of its affiliates or development partners (that is, an employee, temporary contract worker, or designee) responsible for the conduct of the study

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


Locations
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United States, Alabama
Research Site
Mobile, Alabama, United States, 36608
United States, Arizona
Research Site
Phoenix, Arizona, United States, 85029
Research Site
Tucson, Arizona, United States, 85712
United States, California
Research Site
El Cajon, California, United States, 92020
Research Site
Rancho Mirage, California, United States, 92270
Research Site
Spring Valley, California, United States, 91978
United States, Colorado
Research Site
Denver, Colorado, United States, 80230
United States, Florida
Research Site
Clearwater, Florida, United States, 33761
Research Site
Coral Gables, Florida, United States, 33134
Research Site
Jacksonville, Florida, United States, 32216
Research Site
Miami, Florida, United States, 33173
Research Site
West Palm Beach, Florida, United States, 33409
United States, Georgia
Research Site
Woodstock, Georgia, United States, 30189
United States, Kansas
Research Site
Newton, Kansas, United States, 67114
Research Site
Wichita, Kansas, United States, 67205
United States, Kentucky
Research Site
Lexington, Kentucky, United States, 40504
United States, Maryland
Research Site
Frederick, Maryland, United States, 21702
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02111
Research Site
Worcester, Massachusetts, United States, 01605
United States, Missouri
Research Site 1
Saint Louis, Missouri, United States, 63141
Research Site 2
Saint Louis, Missouri, United States, 63141
United States, New York
Research Site
Orchard Park, New York, United States, 14127
Research Site
Rochester, New York, United States, 14609
United States, North Carolina
Research Site
Raleigh, North Carolina, United States, 27612
Research Site
Salisbury, North Carolina, United States, 28144
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45246
United States, Pennsylvania
Research Site
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
Research Site
Mount Pleasant, South Carolina, United States, 29464
United States, South Dakota
Research Site
Rapid City, South Dakota, United States, 57702
United States, Tennessee
Research Site
Knoxville, Tennessee, United States, 37912
United States, Texas
Research Site
Austin, Texas, United States, 78745
Research Site
Houston, Texas, United States, 77074
United States, Utah
Research Site
West Layton, Utah, United States, 84041
United States, Virginia
Research Site
Charlottesville, Virginia, United States, 22911
Research Site
Richmond, Virginia, United States, 23225
United States, Wisconsin
Research Site
Franklin, Wisconsin, United States, 53132
Sponsors and Collaborators
Samumed LLC
Investigators
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Study Director: Yusuf Yazici, M.D. Samumed LLC
  Study Documents (Full-Text)

Documents provided by Samumed LLC:
Study Protocol  [PDF] October 13, 2016
Statistical Analysis Plan  [PDF] October 14, 2016

Publications of Results:
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Responsible Party: Samumed LLC
ClinicalTrials.gov Identifier: NCT02536833    
Other Study ID Numbers: SM04690-OA-02
First Posted: September 1, 2015    Key Record Dates
Results First Posted: September 15, 2020
Last Update Posted: September 15, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samumed LLC:
Osteoarthritis
Samumed
SM04690
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Adavivint
Anti-Inflammatory Agents