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

  • STATUS
    Recruiting
Updated on 25 March 2021

Summary

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

Description

This phase 2 study is a placebo-controlled, double-blind, parallel group study of four concentrations of SM04690 (0.03, 0.07, 0.15, and 0.23 mg per 2 mL injection) injected intraarticularly (IA) into the target knee joint of subjects with moderately to severely symptomatic osteoarthritis (OA). Based on previous studies of SM04690, key phenotypes of laterality (unilateral vs bilateral) as well as chronic pain (as measured by the Widespread Pain Index) were identified as confounding variables impacting the overall assessment of both radiologic and clinical efficacy outcomes. The design of SM04690-OA-04 is based upon previous study designs while assessing strategies to combat the confounding impact of laterality and chronic pain. To evaluate the effect of IA vehicle injection on patient-reported outcomes (PRO) such as pain, stiffness, and function in OA, this study will also include two placebo cohorts-one cohort that receives a 2 mL IA injection of vehicle, and one cohort that receives a sham injection (i.e., a needle stick with 0 mL vehicle injected).

Details
Clinical Study IdentifierTX150158
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Ambulatory
Diagnosis of femorotibial OA in the target knee by standard American College of Rheumatology (ACR) criteria at screening (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
Primary source of pain throughout the body is due to OA in the target knee
Willingness to use an electronic diary on a daily basis in the evening for the screening period and 24-week study duration
Negative drug test for opioids and drugs of abuse, except alcohol and marijuana, at screening
Subjects with depression or anxiety must be clinically stable for 12 weeks prior to screening, 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 it prior to any study-related procedure being performed

Exclusion Criteria

Women who are pregnant, lactating, or have a positive pregnancy result at screening
Women of child bearing potential who are sexually active and are not willing to use a highly effective method of birth control during the study period
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 whom are not using a highly effective method of birth control
Body mass index (BMI) > 35
Partial or complete joint replacement in either knee
Currently requires regular use of ambulatory assistive devices (e.g., wheelchair, parallel bars, walker, canes, or crutches) or use of a lower extremity prosthesis, and/or a structural knee brace
Previous participation in a Samumed clinical trial investigating SM04690
Any surgery (e.g., arthroscopy) in either knee within 26 weeks prior to screening
Any planned surgery during the study period
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 if completely excised. 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 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
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 any study injection, or planned participation in any such trial
Treatment of the target knee with intra-articular corticosteroids (e.g., methylprednisolone) within 12 weeks prior to screening
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; treatment of the target knee with intra-articular corticosteroids greater than 12 weeks prior to screening is allowed
Treatment with systemic corticosteroids greater than 10 mg prednisone or the equivalent per day within 4 weeks prior to screening
Effusion of the target knee clinically requiring aspiration within 12 weeks prior to screening
Use of electrotherapy, acupuncture, and/or chiropractic treatments for knee OA within 4 weeks prior to screening
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 study start
Use of centrally acting analgesics (e.g., duloxetine) within 12 weeks prior to screening
Use of anticonvulsants within 12 weeks prior to screening, unless used for seizure or migraine prophylaxis
Subjects requiring the usage of opioids >1x per week within 12 weeks prior to screening
Use of topical local anesthetic agents (gels, creams, or patches such as the Lidoderm patch) for the treatment of knee OA within 7 days of screening
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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