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A Study Evaluating the Safety, Tolerability and Efficacy of Two Injections of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03727022
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Samumed LLC

Brief Summary:
The primary purpose of this phase 2, placebo-controlled, double-blind, parallel group study is to provide an initial evaluation of two intra-articular (IA) injections of SM04690 (each at the dose of 0.07mg per 2mL injection) approximately six months apart into the target knee of moderately to severely symptomatic osteoarthritis (OA) subjects. All previous studies of SM04690 have involved a single IA injection for a given subject.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, 52-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Two Injections of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
Actual Study Start Date : November 28, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: 0.07 mg SM04690
Two intra-articular injections of 0.07 mg SM04690 in 2 mL vehicle
Drug: SM04690
Healthcare professional-administered intra-articular injections; first performed on Day 1 and second at Week 24

Placebo Comparator: Vehicle
Two intra-articular injections of 0 mg SM04690 in 2 mL vehicle
Drug: Placebo
Healthcare professional-administered intra-articular injections; first performed on Day 1 and second at Week 24




Primary Outcome Measures :
  1. Change from baseline BMD in the treated knee [ Time Frame: Baseline and Weeks 12, 24, 36 and 52 ]
    Evaluate change in bone mineral density (BMD) from baseline in the treated knee compared to placebo by quantitative computed tomography (qCT)

  2. Difference in the change from baseline BMD between the treated and untreated knee [ Time Frame: Baseline and Weeks 12, 24, 36 and 52 ]
    Evaluate difference in the change in BMD from baseline between the treated and untreated knee compared to placebo by qCT

  3. Change from baseline BMD of the spine and hips [ Time Frame: Baseline and Weeks 24 and 52 ]
    Evaluate change in BMD from baseline by dual-energy X-ray absorptiometry (DXA) of the spine and hips

  4. Change from baseline serum bone biomarkers [ Time Frame: Baseline and Weeks 4, 12, 24, 36 and 52 ]
    Evaluate change in serum bone biomarkers (N-terminal propeptides of procollagen type I [PINP] and β-C-terminal telopeptide [β-CTX]) from baseline

  5. Change from baseline serum cartilage biomarker [ Time Frame: Baseline and Weeks 4, 12, 24, 36 and 52 ]
    Evaluate change in serum cartilage biomarker (cartilage oligomeric matrix protein [COMP]) from baseline


Secondary Outcome Measures :
  1. Change from baseline OA pain in the target knee (NRS) [ Time Frame: Baseline, Weeks 1 through 52 ]
    Evaluate change from baseline OA pain in the target knee at each week as assessed by the weekly averages of subject-reported daily pain Numeric Rating Scale (NRS).

  2. Change from baseline OA pain in the target knee (WOMAC pain subscore) [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 ]
    Evaluate change from baseline OA pain in the target knee as assessed by subject-reported monthly Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscore.

  3. Change from baseline OA function in the target knee (WOMAC physical function subscore) [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 ]
    Evaluate change from baseline OA function in the target knee as assessed by subject-reported monthly WOMAC physical function subscore.

  4. Change from baseline OA disease activity [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 ]
    Evaluate change from baseline OA disease activity as assessed by subject-reported monthly Patient Global Assessment.

  5. Change from baseline in medial JSW of the target knee [ Time Frame: Baseline, Weeks 24 and 52 ]
    Evaluate change from baseline in medial joint space width (JSW) as documented by radiograph of the target knee.



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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
  3. Diagnosis of femorotibial OA in the target knee by standard American College of Rheumatology (ACR) criteria at Screening Visit 1 (clinical AND radiographic criteria); OA of the knee is not to be secondary to any rheumatologic conditions (e.g., rheumatoid arthritis)
  4. Pain compatible with OA of the knee(s) for at least 26 weeks prior to Screening Visit 1
  5. Primary source of pain throughout the body is due to OA in the target knee
  6. Daily OA knee pain diary average NRS intensity score ≥ 4 and ≤ 8 in the target knee on the 11-point (0-10) NRS scale for the 7 days immediately preceding Day 1
  7. Pain NRS scores recorded for the target knee on at least 4 out of the 7 days immediately preceding Day 1
  8. Daily OA knee pain diary average NRS intensity score < 4 in the non-target knee on the 11-point (0-10) NRS scale for the 7 days immediately preceding Day 1
  9. Pain NRS scores recorded for the non-target knee on at least 4 out of the 7 days immediately preceding Day 1
  10. WOMAC pain subscore of 20-40 (out of 50) and WOMAC physical function subscore of 68-136 (out of 170) for the target knee at baseline, regardless of if the subject is on symptomatic oral treatment (baseline questionnaire completed during the screening period prior to randomization)
  11. Widespread Pain Index (WPI) score of ≤ 4 and a Symptom Severity Question 2 (SSQ2) score of ≤ 2 at Screening Visit 1
  12. Willingness to use an electronic diary on a daily basis in the evening for the screening period and 52-week study duration
  13. Negative drug test for amphetamine, methamphetamine, buprenorphine, cocaine, methadone, opiates, phencyclidine (PCP), propoxyphene, barbiturates, benzodiazepine, methaqualone, and tricyclic antidepressants, except if any such drugs are clinically indicated and allowed by the protocol, at Screening Visit 1.
  14. Subjects with depression or anxiety must be clinically stable for 12 weeks prior to Screening Visit 1 in the opinion of the Investigator and, if on treatment for depression or anxiety, be on 12 weeks of stable therapy
  15. Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
  16. Subjects must have read and understood the Informed Consent Form (ICF), and must have signed it prior to any study-related procedure being performed
  17. Subject's Screening Visit 1 visit must occur while enrollment into the study is open

Exclusion Criteria:

  1. Women who are pregnant, lactating, or have a positive or indeterminate pregnancy result at Screening Visit 2 or Day 1
  2. Women who are not post-menopausal (defined as 12 months with no menses without an alternative medical cause) or permanently surgically sterile (includes hysterectomy, bilateral salpingectomy, and bilateral oophorectomy, but NOT tubal ligation), who are sexually active, and who are not willing to use birth control during the study period
  3. Males who are sexually active and have a partner who is capable of becoming pregnant, neither of whom have had surgery to become sterilized or who are not using birth control
  4. Body mass index (BMI) > 35
  5. Partial or complete joint replacement in either knee
  6. Currently requires:

    1. regular use (in the opinion of the Investigator) of ambulatory assistive devices (e.g., wheelchair, parallel bars, walker, canes, or crutches), or
    2. use of a lower extremity prosthesis, and/or a structural knee brace (i.e., a knee brace that contains hardware)
  7. Radiographic disease Stage 0, 1, or 4 in the target knee at Screening Visit 1 according to the Kellgren-Lawrence grading of knee OA as assessed by independent central readers
  8. Previous enrollment in a Samumed clinical trial investigating SM04690
  9. Any surgery (e.g., arthroscopy) in either knee within 26 weeks prior to Screening Visit 1
  10. Any bone fracture(s) within 26 weeks prior to Screening Visit 1
  11. Any surgery scheduled during the study period. Non-surgical invasive procedures conducted for a diagnostic or therapeutic purpose scheduled during the study period are not prohibited.
  12. Significant and clinically evident misalignment of either knee that would impact subject function, as determined by the Investigator
  13. History of malignancy within the last 5 years; however, subjects with prior history of in situ basal or squamous cell skin cancer are eligible if completely excised. Subjects with other malignancies are eligible if they have been continuously disease free for at least 5 years prior to Screening Visit 1
  14. Clinically significant abnormal screening hematology values, blood chemistry values, or urinalysis values as determined by the Investigator
  15. Any condition, including laboratory findings not included in the Screening Visit 2 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
  16. Comorbid conditions that could affect study endpoint assessments of the target knee, including, but not limited to, rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gout or pseudogout, and fibromyalgia
  17. Other conditions that, in the opinion of the Investigator, could affect study endpoint assessments of either knee, including, but not limited to, peripheral neuropathy (e.g., diabetic neuropathy), symptomatic hip osteoarthritis, symptomatic degenerative disc disease, and patellofemoral syndrome
  18. Any diagnosed psychiatric condition that includes, but is not limited to, a history of mania, bipolar disorder, psychotic disorder, schizophrenia, schizoaffective disorder, major depressive disorder, or generalized anxiety disorder
  19. Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure, or an observational research trial related to osteoarthritis within 8 weeks prior to Screening Visit 1, or planned participation in any such trial; the last date of participation in the trial, not the last date of receipt of investigational product, must be at least 8 weeks prior to Screening Visit 1
  20. Treatment of the target knee with intra-articular glucocorticoids (e.g., methylprednisolone) within 12 weeks prior to Screening Visit 1
  21. Any intra-articular injection into the target knee with a therapeutic aim including, but not limited to, viscosupplementation (e.g., hyaluronic acid), platelet-rich plasma (PRP), and stem cell therapies within 24 weeks prior to Screening Visit 1; treatment of the target knee with intra-articular glucocorticoids greater than 12 weeks prior to Screening Visit 1 is allowed
  22. Treatment with systemic glucocorticoids greater than 10 mg prednisone or the equivalent per day within 4 weeks prior to Screening Visit 1
  23. Effusion of the target knee clinically requiring aspiration within 12 weeks prior to Screening Visit 1
  24. Use of electrotherapy, acupuncture, and/or chiropractic treatments for knee OA within 4 weeks prior to Screening Visit 1
  25. Any known active infections, including urinary tract infection, upper respiratory tract infection, sinusitis, 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) at Day 1
  26. Subjects requiring the chronic use (i.e., regular and consistent use for ≥ 12 weeks) of centrally acting analgesics (e.g., duloxetine) within 12 weeks prior to Screening Visit 1
  27. Subjects requiring the chronic use (i.e., regular and consistent use for ≥ 12 weeks) of anticonvulsants (not listed in the study protocol) within 12 weeks prior to Screening Visit 1, unless used for seizure or migraine prophylaxis
  28. Subjects requiring the usage of opioids >1x per week within 12 weeks prior to Screening Visit 1
  29. Topical local anesthetic agents (gels, creams, or patches such as the Lidoderm patch) used for the treatment of knee OA within 7 days of Screening Visit 1
  30. 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 in the opinion of the Investigator. In addition, subjects with an HbA1c >9 at Screening Visit 2 will be excluded.
  31. If on NSAIDs for the treatment of OA pain, subjects who have not maintained a stable regimen in the opinion of the Investigator at Screening Visit 1
  32. Any contraindications for performing DXA scans of the hips or spine including but not limited to:

    1. pins, screws, or any surgical implant, either on the spine or any hip that preclude scanning at these sites
    2. severe degenerative changes or fracture deformity in the measurement area
    3. other radiological investigations using contrast media or radionuclides within 7 days of Screening Visit 2
    4. weight that precludes scanning at these sites
  33. Subjects who have had a single or bilateral hip replacement
  34. Subjects who have a current or pending disability claim, workers' compensation, or litigation(s) that may compromise response to treatment
  35. Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at any investigative site, or are directly affiliated with the study at any investigative site
  36. 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, or who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of said employees 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): NCT03727022


Contacts
Contact: Samumed Clinical Trials 1-855-222-0515 clinicaltrials@samumed.com

Locations
United States, Arizona
Research Site Not yet recruiting
Phoenix, Arizona, United States, 85018
Research Site Recruiting
Phoenix, Arizona, United States, 85053
United States, California
Research Site Not yet recruiting
Canoga Park, California, United States, 91303
Research Site Recruiting
Carmichael, California, United States, 95628
Research Site Recruiting
La Mesa, California, United States, 91941
Research Site Not yet recruiting
Sacramento, California, United States, 95817
United States, Florida
Research Site Recruiting
Edgewater, Florida, United States, 32132
Research Site Not yet recruiting
Miami, Florida, United States, 33143
United States, Georgia
Research Site Recruiting
Woodstock, Georgia, United States, 30189
United States, Louisiana
Research Site Not yet recruiting
Jefferson, Louisiana, United States, 70130
United States, Missouri
Research Site Recruiting
Kansas City, Missouri, United States, 64114
United States, New Mexico
Research Site Not yet recruiting
Albuquerque, New Mexico, United States, 87102
United States, Ohio
Research Site Recruiting
Cincinnati, Ohio, United States, 45246
United States, South Carolina
Research Site Recruiting
Charleston, South Carolina, United States, 29406
United States, Texas
Research Site Not yet recruiting
San Angelo, Texas, United States, 76904
Sponsors and Collaborators
Samumed LLC
Investigators
Study Director: Yusuf Yazici, M.D. Samumed LLC

Responsible Party: Samumed LLC
ClinicalTrials.gov Identifier: NCT03727022     History of Changes
Other Study ID Numbers: SM04690-OA-06
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Samumed LLC:
SM04690
Wnt pathway inhibitor
osteoarthritis
Samumed

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