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

Use our guide to learn which trials are right for you!

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
Beavercreek, Ohio 45431
?
mi
from
Beavercreek, OH
Click here to add this to my saved trials
Albuquerque, New Mexico
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Anaheim, California
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Atlanta, Georgia
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Bay City, Michigan 48706
?
mi
from
Bay City, MI
Click here to add this to my saved trials
Berlin, New Jersey 08009
?
mi
from
Berlin, NJ
Click here to add this to my saved trials
Chicago, Illinois
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Clearwater, Florida
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Columbus, Georgia
?
mi
from
Columbus, GA
Click here to add this to my saved trials
Duncansville, Pennsylvania 16635
?
mi
from
Duncansville, PA
Click here to add this to my saved trials
Edgewood, Kentucky 41017
?
mi
from
Edgewood, KY
Click here to add this to my saved trials
Fargo, North Dakota 58105
?
mi
from
Fargo, ND
Click here to add this to my saved trials
Hartsdale, New York 10530
?
mi
from
Hartsdale, NY
Click here to add this to my saved trials
Hialeah, Florida 33012
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
High Point, North Carolina
?
mi
from
High Point, NC
Click here to add this to my saved trials
Houston, Texas
?
mi
from
Houston, TX
Click here to add this to my saved trials
Idaho Falls, Idaho 83404
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
Jacksonville, Florida
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Katy, Texas 77498
?
mi
from
Katy, TX
Click here to add this to my saved trials
Kenosha, Wisconsin 53144
?
mi
from
Kenosha, WI
Click here to add this to my saved trials
La Mesa, California
?
mi
from
La Mesa, CA
Click here to add this to my saved trials
Las Vegas, Nevada
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lauderdale Lakes, Florida 33319
?
mi
from
Lauderdale Lakes, FL
Click here to add this to my saved trials
Lincoln, Nebraska
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
Marietta, Georgia 30060
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Memphis, Tennessee 38119
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
New Orleans, Louisiana
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New York, New York
?
mi
from
New York, NY
Click here to add this to my saved trials
Newnan, Georgia 30265
?
mi
from
Newnan, GA
Click here to add this to my saved trials
North Hollywood, California 91606
?
mi
from
North Hollywood, CA
Click here to add this to my saved trials
Ocoee, Florida 34761
?
mi
from
Ocoee, FL
Click here to add this to my saved trials
Oklahoma City, Oklahoma
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orlando, Florida
?
mi
from
Orlando, FL
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Plano, TX
Click here to add this to my saved trials
Port Orange, Florida 32127
?
mi
from
Port Orange, FL
Click here to add this to my saved trials
Rapid City, South Dakota
?
mi
from
Rapid City, SD
Click here to add this to my saved trials
Saint Louis, Missouri
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Diego, California
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Marcos, California 92078
?
mi
from
San Marcos, CA
Click here to add this to my saved trials
Santa Ana, California 92703
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Sarasota, Florida 34232
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
Spring Valley, California 91978
?
mi
from
Spring Valley, CA
Click here to add this to my saved trials
Stamford, Connecticut 06905
?
mi
from
Stamford, CT
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Valparaiso, Indiana 46383
?
mi
from
Valparaiso, IN
Click here to add this to my saved trials
Waterbury, Connecticut 06708
?
mi
from
Waterbury, CT
Click here to add this to my saved trials
West Des Moines, Iowa 50265
?
mi
from
West Des Moines, IA
Click here to add this to my saved trials
Whittier, California 90602
?
mi
from
Whittier, CA
Click here to add this to my saved trials