Status:
TERMINATED
Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Teva Pharmaceutical Industries, Ltd.
Conditions:
Chronic Low Back Pain
Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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-se...
Eligibility Criteria
Inclusion
- Key
- Clinical diagnosis of non-radicular moderate-to-severe CLBP for ≥3 months (prior to screening visit)
- 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
- History of inadequate relief of CLBP from non-pharmacologic therapy
- Willing to undergo joint replacement (JR) surgery, if necessary
- History of regular analgesic medication use
- History of inadequate pain relief or intolerance to analgesics used for chronic LBP
- Key
Exclusion
- Patient is not a candidate for MRI
- History of major trauma or back surgery in the past 6 months prior to the screening visit
- History or presence of pyriformis syndrome
- Evidence on baseline lumbar spine magnetic resonance imaging of potentially confounding conditions
- History or evidence on joint imaging of conditions that may confound joint safety evaluation
- Evidence or symptoms consistent with autonomic dysfunction (e.g., orthostatic hypotension and/or autonomic symptoms) as defined in the protocol
- Recent use of longer acting pain medications
- Other medical conditions that may interfere with participation or accurate assessments during the trial
- Note: Other protocol defined Inclusion/ Exclusion criteria apply.
Key Trial Info
Start Date :
October 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2019
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT03285646
Start Date
October 30 2017
End Date
May 2 2019
Last Update
June 30 2021
Active Locations (56)
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1
Regeneron Research Site
Phoenix, Arizona, United States, 85053
2
Regeneron Research Site
Tucson, Arizona, United States, 85704
3
Regeneron Research Site
Tucson, Arizona, United States, 85712
4
Regeneron Research Site
Anaheim, California, United States, 92801