Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee
Condition: Chronic Low Back Pain; Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Hip; Back Pain; Low Back Pain
Intervention: Fasinumab; Placebo
Intervention description: Subcutaneous (SC) every 4 weeks (Q4W); Subcutaneous (SC) every 4 weeks (Q4W)
Intervention MeSH terms: Fasinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Knee; Hip

Summary:

      The primary objective of the study is to evaluate the efficacy of fasinumab in relieving
      Chronic low back pain (CLBP) as compared to placebo in participants with a clinical diagnosis
      of moderate-to-severe non-radicular CLBP and Osteoarthritis (OA) of the knee or hip when
      treated for up to 16 weeks. The secondary objectives of the study are: To evaluate the safety
      and tolerability of fasinumab compared to placebo when participants with a clinical diagnosis
      of moderate-to-severe non-radicular CLBP and OA of the knee or hip are treated for up to 16
      weeks; To characterize the concentrations of fasinumab in serum over time when participants
      with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip
      are treated for up to 16 weeks; To evaluate the immunogenicity of fasinumab when treated for
      up to 16 weeks in participants with a clinical diagnosis of moderate-to-severe non-radicular
      CLBP and OA of the knee or hip.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Clinical diagnosis of non-radicular moderate-to-severe CLBP for ≥3 months (prior to
             screening visit)

          2. Clinical diagnosis of OA in at least 1 hip or knee joint based on the American College
             of Rheumatology Criteria with radiographic evidence of OA (K-L ≥2) at screening

          3. History of inadequate relief of CLBP from non-pharmacologic therapy

          4. Willing to undergo joint replacement (JR) surgery, if necessary

          5. History of regular analgesic medication use

          6. History of inadequate pain relief or intolerance to analgesics used for chronic LBP

        Key Exclusion Criteria:

          1. Patient is not a candidate for MRI

          2. History of major trauma or back surgery in the past 6 months prior to the screening
             visit

          3. History or presence of pyriformis syndrome

          4. Evidence on baseline lumbar spine magnetic resonance imaging of potentially
             confounding conditions

          5. History or evidence on joint imaging of conditions that may confound joint safety
             evaluation

          6. Evidence or symptoms consistent with autonomic dysfunction (e.g., orthostatic
             hypotension and/or autonomic symptoms) as defined in the protocol

          7. Recent use of longer acting pain medications

          8. Other medical conditions that may interfere with participation or accurate assessments
             during the trial

        Note: Other protocol defined Inclusion/ Exclusion criteria apply.