Clinical trial: A Study Utilizing Patient-Reported Outcomes to Evaluate the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis (NCT04385303)

Eligibility criteria:
Key Inclusion Criteria:

          -  Males and females between 40 and 80 years of age, inclusive, in general good health
             apart from their knee OA

          -  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 the Screening Visit (clinical AND radiographic
             criteria); OA of the knee is not to be secondary to any rheumatologic conditions
             (e.g., rheumatoid arthritis)

          -  Radiographic disease Stage 2 or 3 in target knee within 24 weeks of the Screening
             Visit according to the Kellgren-Lawrence (KL) grading of knee OA as assessed by
             independent central readers

          -  Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)

          -  Pain compatible with OA of the knee(s) for at least 26 weeks prior to the Screening
             Visit

          -  Primary source of pain throughout the body is due to OA in the target knee

          -  Body mass index (BMI) ≤ 35 kg/m2 at the Screening Visit

          -  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

        Key Exclusion Criteria:

          -  Pregnant women, breastfeeding women, and 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) who have a positive or indeterminate pregnancy test result at the
             Screening Visit or Day 1

          -  Significant malalignment of anatomical axis (medial angle formed by the femur and
             tibia) of the target knee (varus > 10°, valgus > 10°) by radiograph within 24 weeks of
             the Screening Visit as assessed by independent central readers

          -  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 Day 1

          -  Intra-articular (IA) injection into the target knee with a therapeutic aim including,
             but not limited to hyaluronic acid, platelet-rich plasma (PRP), and stem cell
             therapies within 26 weeks prior to Day 1; or IA glucocorticoids within 12 weeks prior
             to Day 1 allowed

          -  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 within 26 weeks
             prior to the Screening Visit, or planned participation in any such trial

          -  Subjects requiring the use of opioids > 1x per week within 12 weeks prior to Day 1

          -  History of malignancy within the last 5 years; not including subjects with prior
             history of adequately treated in situ cervical cancer or basal or squamous cell skin
             cancer

          -  Clinically significant abnormal screening hematology values, blood chemistry values,
             or urinalysis values as determined by the Investigator

          -  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 Day 1
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment