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A Study Utilizing Patient-Reported and Radiograhic Outcomes and Evaluating the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteaoarthritis (STRIDES-X-ray)

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ClinicalTrials.gov Identifier: NCT03928184
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Samumed LLC

Brief Summary:
This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intra-articularly (IA) into the target knee (most painful) joint of moderately to severely symptomatic osteoarthritis (OA) subjects at a single dose of 0.07 mg lorecivivint per 2 mL injection. This study will utilize radiographs and patient reported outcomes (PROs) to evaluate the safety and efficacy of lorecivivint.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Lorecivivint Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 725 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, 56-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Utilizing Patient-Reported and Radiographic Outcomes to Evaluate the Efficacy and Safety of a Single Injection of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
Actual Study Start Date : May 17, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 0.07 mg lorecivivint
One intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle
Drug: Lorecivivint
Healthcare professional-administrered intra-articular injection; performed on Day 1
Other Name: SM04690

Placebo Comparator: Vehicle
One intra-articular injection of 0 mg lorecivivint in 2 ml vehicle
Drug: Placebo
Healthcare professional-administered intra-articular injection; performed on Day 1




Primary Outcome Measures :
  1. Change from baseline in OA pain in the target knee (Pain NRS) [ Time Frame: Baseline and Week 12 ]
    Evaluate change from baseline OA pain in the target knee as assessed by the weekly averages of daily pain Numeric Rating Scale (NRS). The pain NRS is an 11-point scale [0-10] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain.


Secondary Outcome Measures :
  1. Change from baseline in OA pain in the target knee (Pain NRS) [ Time Frame: Baseline, Weeks 24 and 52 ]
    Evaluate change from baseline OA pain in the target knee as assessed by the weekly averages of daily pain Numeric Rating Scale (NRS). The pain NRS is an 11-point scale [0-10] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain.

  2. Change from baseline in OA function in the target knee (WOMAC Function) [ Time Frame: Baseline, Weeks 12, 24 and 52 ]
    Evaluate change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Arthritis Index (WOMAC) physical function (WOMAC Function) subscore. The WOMAC is a widely-used, proprietary outcome measurement tool used 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 4 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore ranges from 0 to 68.

  3. Change from baseline in OA disease activity (Patient Global Assessment) [ Time Frame: Baseline, Weeks 12, 24 and 52 ]
    Evaluate change from baseline OA disease activity as assessed by Patient Global Assessment. The Patient Global Assessment is an 11-point [0-10] Numeric Rating Scale [NRS] on which the subjects will rate how they feel their target knee OA is doing, considering all the ways in which their target knee OA may affect them. The NRS is anchored by descriptors at each end ("Very Good" on the left and "Very Bad" on the right).

  4. Change from baseline in usage of nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen for target knee OA pain [ Time Frame: Baseline and Week 52 ]

Other Outcome Measures:
  1. Change from baseline in serum bone biomarkers [ Time Frame: Baseline and Week 56 ]
    Evaluate change from baseline in serum bone biomarkers N-terminal propeptides of procollagen type I [PINP] and β-C-terminal telopeptide [β-CTX]

  2. Change from baseline in a serum cartilage biomarker [ Time Frame: Baseline and Week 56 ]
    Evaluate change from baseline in serum cartilage biomarker cartilage oligomeric matrix protein [COMP]

  3. Change from baseline in medial joint space width (mJSW) in the target knee [ Time Frame: Baseline and Week 52 ]
    Evaluate change from baseline in mJSW as documented by radiograph of the target knee

  4. Change from baseline in health-related quality of life (HRQOL) [ Time Frame: Baseline and Week 52 ]
    Evaluate change from baseline in HRQOL as assessed by the 36-Item Short Form Health Survey (SF-36). The SF-36 consists of eight scaled scores which are the weighted sums of the questions in their section (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health). Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  5. Change from baseline in OA pain in the target knee (WOMAC Pain) [ Time Frame: Baseline, Weeks 12, 24 and 52 ]
    Evaluate change from baseline in OA pain in the target knee as assessed by WOMAC Pain subscore. The WOMAC is a widely-used, proprietary outcome measurement tool used 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 4 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore ranges from 0 to 20.

  6. Change from baseline in OA pain, function and stiffness (WOMAC Total score) [ Time Frame: Baseline, Weeks 12, 24 and 52 ]
    Evaluate change from baseline in OA pain, function and stiffness as a composite outcome measure as assessed by WOMAC Total score. The WOMAC is a widely-used, proprietary outcome measurement tool used 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 4 (highest pain/highest stiffness/lowest function). WOMAC Total is a composite of the three domains (pain/stiffness/function) with a total score of 0 to 96.



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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:

  • Ambulatory (single assistive devices such as canes allowed if needed less than 50% of the time, subjects requiring a walker are excluded)
  • Diagnosis of femorotibial OA in the target knee by standard American College of Rheumatology (ACR) criteria at study start (clinical AND radiographic criteria); OA of the knee is not to be secondary to any rheumatologic conditions (e.g., rheumatoid arthritis)
  • Pain compatible with OA of the knee(s) for at least 26 weeks prior to Screening Visit 1
  • Primary source of pain throughout the body is due to OA in the target knee
  • Body mass index (BMI) ≤ 40 kg/m2
  • 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 study start
  • 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 study start
  • WOMAC Pain subscore of 20-40 (out of 50) for the target knee at baseline regardless of if the subject is on symptomatic oral treatment
  • WOMAC Function subscore of 68-136 (out of 170) for the target knee at baseline regardless of if the subject is on symptomatic oral treatment
  • Willingness to use an electronic diary daily in the evening for the screening period and 56-Week study duration
  • Negative drug test for amphetamine, buprenorphine, cocaine, methadone, opiates, phencyclidine (PCP), propoxyphene, barbiturates, benzodiazepine, methaqualone, and tricyclic antidepressants, unless any of these drugs are allowed per protocol and prescribed by a physician to treat a specific condition
  • Subjects with depression or anxiety must be clinically stable for 12 weeks prior to Screening Visit 1 and, if on treatment for depression or anxiety, be on 12 weeks of stable therapy
  • Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
  • Subjects must have read and understood the informed consent form, and must have signed and dated it prior to any study-related procedure being performed

Exclusion Criteria:

  • Women who are pregnant, lactating, or have a positive or indeterminate pregnancy result at study start
  • 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
  • Men 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
  • Partial or complete joint replacement in either knee
  • Currently requires use of a lower extremity prosthesis, and/or a structural knee brace (i.e., a knee brace that contains hardware)
  • Any surgery (e.g., arthroscopy) in either knee within 26 weeks prior to study start
  • Any intra-articular (IA) 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 26 weeks prior to study start; treatment of the target knee with IA glucocorticoids more than 12 weeks prior to study start is allowed
  • Effusion of the target knee clinically requiring aspiration within 12 weeks prior to study start
  • Use of electrotherapy, acupuncture, and/or chiropractic treatments for knee OA within 4 weeks prior to study start
  • Any bone fracture(s) within 26 weeks prior to study start
  • Previous treatment with lorecivivint (SM04690)
  • Subjects who have previously failed screening on this protocol and fail to meet re-screening criteria
  • Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure for knee OA within 26 weeks prior to study start, or planned participation in any such trial
  • Treatment with systemic glucocorticoids greater than 10 mg prednisone or the equivalent per day within 4 weeks prior to study start
  • Current use, or use within 12 weeks prior to study start, of centrally acting analgesics
  • Current use, or use within 12 weeks prior to study start, of anticonvulsants
  • Subjects requiring the use of opioids > 1x per week within 12 weeks prior to study start
  • Topical local anesthetic agents (gels, creams, or patches such as the Lidoderm patch) used for the treatment of knee OA within 7 days of study start
  • Any surgery scheduled during the study period. Non-surgical invasive procedures conducted for a diagnostic or therapeutic purpose scheduled during the study period are allowed.
  • 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 study start
  • 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
  • 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
  • Any known active infections, including urinary tract infection, upper respiratory tract infection, sinusitis, suspicion of IA infection, hepatitis B or hepatitis C infection, and/or infections that may compromise the immune system such as human immunodeficiency virus (HIV) at study start
  • Subjects with an HbA1c > 9 at study start will be excluded.
  • Subjects who have a current or pending disability claim, workers' compensation, or litigation(s) that may compromise response to treatment
  • 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
  • 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): NCT03928184


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

Locations
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United States, Arizona
Research Site Recruiting
Tucson, Arizona, United States, 85712
United States, Oklahoma
Research Site Recruiting
Oklahoma City, Oklahoma, United States, 73103
United States, South Dakota
Research Site Recruiting
Rapid City, South Dakota, United States, 57702
Sponsors and Collaborators
Samumed LLC
Investigators
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Study Director: Yusuf Yazici, M.D. Samumed LLC

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Responsible Party: Samumed LLC
ClinicalTrials.gov Identifier: NCT03928184     History of Changes
Other Study ID Numbers: SM04690-OA-11
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
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:
SM04690
Wnt pathway inhibitor
osteoarthritis
Samumed
lorecivivint

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Adavivint
Anti-Inflammatory Agents