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

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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.


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
Clearwater, Florida
2511
mi
from 98109
Clearwater, FL
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Albuquerque, New Mexico
1184
mi
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Albuquerque, NM
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Anaheim, California
980
mi
from 98109
Anaheim, CA
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Atlanta, Georgia
2179
mi
from 98109
Atlanta, GA
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Bay City, Michigan 48706
?
mi
from 98109
Bay City, MI
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Beavercreek, Ohio 45431
?
mi
from 98109
Beavercreek, OH
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Berlin, New Jersey 08009
2389
mi
from 98109
Berlin, NJ
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Chicago, Illinois
1733
mi
from 98109
Chicago, IL
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Columbus, Georgia
2207
mi
from 98109
Columbus, GA
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Duncansville, Pennsylvania 16635
2206
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Duncansville, PA
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Edgewood, Kentucky 41017
?
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from 98109
Edgewood, KY
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Fargo, North Dakota 58105
?
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Fargo, ND
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Hartsdale, New York 10530
2401
mi
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Hartsdale, NY
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Hialeah, Florida 33012
?
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Hialeah, FL
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High Point, North Carolina
2291
mi
from 98109
High Point, NC
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Houston, Texas
1890
mi
from 98109
Houston, TX
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Idaho Falls, Idaho 83404
?
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Idaho Falls, ID
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Jacksonville, Florida
2452
mi
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Jacksonville, FL
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Katy, Texas 77498
?
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Katy, TX
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Kenosha, Wisconsin 53144
?
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Kenosha, WI
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La Mesa, California
1064
mi
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La Mesa, CA
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Las Vegas, Nevada
873
mi
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Las Vegas, NV
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Lauderdale Lakes, Florida 33319
?
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Lauderdale Lakes, FL
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Lincoln, Nebraska
1346
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Lincoln, NE
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Marietta, Georgia 30060
?
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Marietta, GA
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Memphis, Tennessee 38119
?
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Memphis, TN
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2731
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Miami, FL
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New Orleans, Louisiana
2099
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New Orleans, LA
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New York, New York
2402
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New York, NY
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Newnan, Georgia 30265
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Newnan, GA
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North Hollywood, California 91606
?
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North Hollywood, CA
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Ocoee, Florida 34761
2538
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from 98109
Ocoee, FL
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Oklahoma City, Oklahoma
1523
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Oklahoma City, OK
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Orlando, Florida
2547
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Orlando, FL
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1116
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Phoenix, AZ
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1673
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Plano, TX
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Port Orange, Florida 32127
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Port Orange, FL
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Rapid City, South Dakota
949
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Rapid City, SD
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Saint Louis, Missouri
1721
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Saint Louis, MO
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San Diego, California
1065
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San Diego, CA
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San Marcos, California 92078
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San Marcos, CA
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Santa Ana, California 92703
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Santa Ana, CA
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Sarasota, Florida 34232
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Sarasota, FL
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Spring Valley, California 91978
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Spring Valley, CA
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Stamford, Connecticut 06905
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1221
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Tucson, AZ
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Valparaiso, Indiana 46383
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Valparaiso, IN
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Waterbury, Connecticut 06708
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Waterbury, CT
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West Des Moines, Iowa 50265
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West Des Moines, IA
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Whittier, California 90602
969
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Whittier, CA
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