Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee
Status: | Active, not recruiting |
---|---|
Conditions: | Arthritis, Back Pain, Back Pain, Osteoarthritis (OA) |
Therapuetic Areas: | Musculoskeletal, Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/23/2018 |
Start Date: | December 20, 2017 |
End Date: | May 1, 2019 |
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee
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 patients 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 patients 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 patients 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 patients with a clinical diagnosis of moderate-to-severe non-radicular CLBP
and OA of the knee or hip.
Chronic low back pain (CLBP) as compared to placebo in patients 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 patients 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 patients 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 patients with a clinical diagnosis of moderate-to-severe non-radicular CLBP
and OA of the knee or hip.
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 may apply.
We found this trial at
50
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials