A Study to Assess the Safety and Efficacy of a Single Dose of UBX0101 in Patients With Osteoarthritis of the Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: UBX0101; Placebo
Intervention description: Investigational drug intra-articular injection; Placebo intra-articular injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 183.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Painful Osteoarthritis; Osteoarthritis, Knee; Senescence

Summary:

      A study to assess efficacy, safety, and tolerability of a single-dose intra-articular
      administration of UBX0101 in patients with moderate to severe painful knee osteoarthritis
      (OA).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Patients who are ambulatory with a diagnosis of OA of the knee and who have baseline
             pain with a mean of ≥ 4 and ≤ 9 on the 11-point (0-10) average daily pain NRS for at
             least five of seven days during the Screening period.

          -  Kellgren-Lawrence grade of 1-4 on a weight-bearing radiograph of target knee.

          -  Patients aged ≥ 40 and ≤ 85 years.

          -  Patients are permitted but not required to use an oral NSAID, serotonin and
             norepinephrine reuptake inhibitors (SNRIs), tramadol, or acetaminophen, provided that
             they have been taking a stable dose and regimen of medication for at least 4 weeks
             prior to Screening.

        Key Exclusion Criteria:

          -  Patients with any condition, including laboratory or imaging findings and findings in
             the medical history or in the pre-study assessments, that in the opinion of the
             Investigator or the Medical Monitor constitutes a risk or contraindication for
             participation in the study or that could interfere with the study objectives, conduct,
             or evaluation or prevent the patient from fully participating in all aspects of the
             study.

          -  Patients with a body mass index (BMI) ≥40 kg/m2 or a body habitus that precludes the
             MRI.

          -  Patients with fibromyalgia

          -  Systemic autoimmune disease with musculoskeletal involvement or any history of a
             systemic inflammatory arthritis

          -  Patients who have received IA treatment in the target knee with steroids or hyaluronic
             acid derivatives within the last 16 weeks prior to Screening, or with extended-release
             corticosteroid (e.g., Zilretta®) within the last 20 weeks

          -  Patients who are using a topical NSAID or topical analgesics on the target knee.

          -  Patients who have used opioid analgesics (other than tramadol), marijuana or
             marijuana-derived products (e.g., cannabidiol), and topical capsaicin on the target
             knee within 8 weeks prior to Screening

          -  Patients with a history of traumatic knee injury to the target knee, including, but
             not limited to, patients with meniscal root tear, within 2 years of study entry.

          -  Patients who have undergone diagnostic arthroscopy to the target knee in the previous
             6 months.

          -  Patients who have undergone arthroscopic surgery (including microfracture and
             meniscectomy) on the target knee in the last 2 years prior to the Screening visit or
             are anticipated to have arthroscopic surgery on either knee at any time during the
             study period.

          -  Patients with a history of previous total or partial knee arthroplasty.

          -  Patients with an effusion at the Screening visit, which, in the opinion of the
             Investigator following examination and discussions with the patient, requires drainage
             for symptom relief.

          -  Patients who have had regenerative joint procedures on any joint, including, but not
             limited to, platelet-rich plasma injections, stem cell transplantation, autologous
             chondrocyte transplantation, or mosaicplasty.

          -  Patients with secondary arthritis that involves the target knee or would confound
             assessments of knee OA