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Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee (FACT CLBP 1)

Primary Purpose

Chronic Low Back Pain, Osteoarthritis

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Fasinumab
Placebo
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Knee, Hip

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site #1
  • Regeneron Research Site #2
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site #1
  • Regeneron Research Site #2
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Fasinumab

Placebo

Arm Description

Subcutaneous (SC) every 4 weeks (Q4W)

SC every 4 weeks

Outcomes

Primary Outcome Measures

Change From Baseline to Week 16 in the Average Daily Low Back Pain Intensity (LBPI) Numeric Rating Scale (NRS) Score
Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain.

Secondary Outcome Measures

Change From Baseline to Week 16 in the Roland Morris Disability Questionnaire (RMDQ) Total Score
The RMDQ is a self-administered, health status measure for lower back pain (LBP). It measures pain and function using 24 items describing limitations to everyday life that can be caused by LBP. The score of the RMDQ is the total number of items checked from a minimum of 0 (no disability) to a maximum of 24 (maximum disability), where lower scores are indicative of better function.
Change From Baseline to Week 16 in Patient Global Assessment (PGA) of Low Back Pain (LBP) Score
The PGA of LBP is a participant assessed 5 point Likert scale of LBP ranging from 1-5 where 1 = very well; 2 = well; 3 = fair; 4 = poor; and 5 = very poor.
Number of Participants Achieving ≥30% Reduction From Baseline to Week 16 in Average Daily LBPI NRS Score
Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain.
Change From Baseline to Week 16 in the Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Score
The BPI-sf is a self-administered questionnaire for participants to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. With a recall period of 24 hours, the questionnaire contains the front and back body diagrams, the 4 pain severity items and 7 pain interference items rated on 0-10 scale; total interference score ranges from 0-10 (0, does not interfere; 10 completely interferes), and the question about percentage of pain relief by analgesics. The BPI pain interference is typically scored as the mean of the 7 interference items.
Number of Adjudicated Arthropathy (AA) Events
Adjudicated arthropathy (AA) is a composite term that encompasses the following conditions: Rapidly progressive OA type 1 and 2, Subchondral insufficiency fractures, and Primary Osteonecrosis. AAs were also evaluated to determine if they met Destructive Arthropathy criteria.
Number of Adjudicated Arthropathy (AA) Events Meeting Destructive Arthropathy (DA) Criteria
Destructive arthropathy (DA) is a unique clinical form of rapidly destructive arthropathy over and above that seen in the normal progression of OA. DA criteria can be associated with Rapidly Progressive Osteoarthritis type 2, Subchondral Insufficiency fracture, and Primary Osteonecrosis.
Number of Treatment-Emergent Adverse Events (TEAEs)
Treatment-emergent adverse events (TEAEs) are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period.
Number of Sympathetic Nervous System (SNS) Dysfunction Events
Potential events of sympathetic nervous system (SNS) dysfunction were monitored throughout the study through physical examination, AE reporting, assessment of orthostatic hypotension, and the Survey of Autonomic Symptoms. Sympathetic nervous system dysfunction was diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist.
Number of Peripheral Sensory Adverse Events (AEs) That Require a Neurology Consultation
Any peripheral sensory AE (eg, paraesthesia and hypoaesthesia) that required a neurology consultation.
Number of All-Cause Joint Replacement (JR) Surgery Events
All joint replacement surgery events regardless of cause.
Number of Joint Replacement (JR) Surgery Events Reported at Telephone Survey After Last Dose of Study Drug
An end of study phone contact was conducted approximately 52 weeks following the last dose of study drug (week 12) to evaluate the number of participants who had undergone or were scheduled for JR surgery.
Number of Participants With at Least One Positive Anti-Drug Antibody (ADA) Assay
Samples for Anti-Drug Antibody (ADA) evaluation were collected at baseline and at subsequent study visits. ADA variables include ADA status (+ or -) and titer as follows: Total participants negative in the ADA assay at all time points analyzed. Pre-existing immunoreactivity - positive response at baseline with all post-dose results negative, or a positive response at baseline with all post-dose responses less than 9-fold over baseline titer levels. Treatment emergent - post-dose positive result when baseline results were negative. Persistent - A positive result detected in at least 2 consecutive post baseline samples separated by at least a 16-week post baseline period, with no negative results in-between. Indeterminate - A positive result at the last collection time point analyzed only. Transient - Not persistent or indeterminate regardless of any missing samples. Treatment boosted - any post-dose positive result at least 9-fold over the baseline level when baseline is positive.
Serum Concentration of Functional Fasinumab Over Time
Summary of mean concentration of functional fasinumab are presented by nominal time point.

Full Information

First Posted
September 14, 2017
Last Updated
June 9, 2021
Sponsor
Regeneron Pharmaceuticals
Collaborators
Teva Pharmaceutical Industries, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03285646
Brief Title
Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee
Acronym
FACT CLBP 1
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Due to implementation of an urgent safety measure, enrollment and dosing in R475-PN-1612 was stopped; enrolled participants entered the 20-week safety follow-up
Study Start Date
October 30, 2017 (Actual)
Primary Completion Date
May 5, 2018 (Actual)
Study Completion Date
May 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Teva Pharmaceutical Industries, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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-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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain, Osteoarthritis
Keywords
Knee, Hip

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fasinumab
Arm Type
Experimental
Arm Description
Subcutaneous (SC) every 4 weeks (Q4W)
Arm Title
Placebo
Arm Type
Experimental
Arm Description
SC every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Fasinumab
Other Intervention Name(s)
REGN475
Intervention Description
Subcutaneous (SC) every 4 weeks (Q4W)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous (SC) every 4 weeks (Q4W)
Primary Outcome Measure Information:
Title
Change From Baseline to Week 16 in the Average Daily Low Back Pain Intensity (LBPI) Numeric Rating Scale (NRS) Score
Description
Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain.
Time Frame
Week 1, Week 2, Week 4, Week 8, Week 12, Week 16
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 16 in the Roland Morris Disability Questionnaire (RMDQ) Total Score
Description
The RMDQ is a self-administered, health status measure for lower back pain (LBP). It measures pain and function using 24 items describing limitations to everyday life that can be caused by LBP. The score of the RMDQ is the total number of items checked from a minimum of 0 (no disability) to a maximum of 24 (maximum disability), where lower scores are indicative of better function.
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16
Title
Change From Baseline to Week 16 in Patient Global Assessment (PGA) of Low Back Pain (LBP) Score
Description
The PGA of LBP is a participant assessed 5 point Likert scale of LBP ranging from 1-5 where 1 = very well; 2 = well; 3 = fair; 4 = poor; and 5 = very poor.
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16
Title
Number of Participants Achieving ≥30% Reduction From Baseline to Week 16 in Average Daily LBPI NRS Score
Description
Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain.
Time Frame
Week 16
Title
Change From Baseline to Week 16 in the Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Score
Description
The BPI-sf is a self-administered questionnaire for participants to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. With a recall period of 24 hours, the questionnaire contains the front and back body diagrams, the 4 pain severity items and 7 pain interference items rated on 0-10 scale; total interference score ranges from 0-10 (0, does not interfere; 10 completely interferes), and the question about percentage of pain relief by analgesics. The BPI pain interference is typically scored as the mean of the 7 interference items.
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16
Title
Number of Adjudicated Arthropathy (AA) Events
Description
Adjudicated arthropathy (AA) is a composite term that encompasses the following conditions: Rapidly progressive OA type 1 and 2, Subchondral insufficiency fractures, and Primary Osteonecrosis. AAs were also evaluated to determine if they met Destructive Arthropathy criteria.
Time Frame
Up to Week 36
Title
Number of Adjudicated Arthropathy (AA) Events Meeting Destructive Arthropathy (DA) Criteria
Description
Destructive arthropathy (DA) is a unique clinical form of rapidly destructive arthropathy over and above that seen in the normal progression of OA. DA criteria can be associated with Rapidly Progressive Osteoarthritis type 2, Subchondral Insufficiency fracture, and Primary Osteonecrosis.
Time Frame
Up to Week 36
Title
Number of Treatment-Emergent Adverse Events (TEAEs)
Description
Treatment-emergent adverse events (TEAEs) are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period.
Time Frame
Up to Week 16
Title
Number of Sympathetic Nervous System (SNS) Dysfunction Events
Description
Potential events of sympathetic nervous system (SNS) dysfunction were monitored throughout the study through physical examination, AE reporting, assessment of orthostatic hypotension, and the Survey of Autonomic Symptoms. Sympathetic nervous system dysfunction was diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist.
Time Frame
Up to Week 36
Title
Number of Peripheral Sensory Adverse Events (AEs) That Require a Neurology Consultation
Description
Any peripheral sensory AE (eg, paraesthesia and hypoaesthesia) that required a neurology consultation.
Time Frame
Up to Week 36
Title
Number of All-Cause Joint Replacement (JR) Surgery Events
Description
All joint replacement surgery events regardless of cause.
Time Frame
Up to Week 36
Title
Number of Joint Replacement (JR) Surgery Events Reported at Telephone Survey After Last Dose of Study Drug
Description
An end of study phone contact was conducted approximately 52 weeks following the last dose of study drug (week 12) to evaluate the number of participants who had undergone or were scheduled for JR surgery.
Time Frame
Up to Week 64
Title
Number of Participants With at Least One Positive Anti-Drug Antibody (ADA) Assay
Description
Samples for Anti-Drug Antibody (ADA) evaluation were collected at baseline and at subsequent study visits. ADA variables include ADA status (+ or -) and titer as follows: Total participants negative in the ADA assay at all time points analyzed. Pre-existing immunoreactivity - positive response at baseline with all post-dose results negative, or a positive response at baseline with all post-dose responses less than 9-fold over baseline titer levels. Treatment emergent - post-dose positive result when baseline results were negative. Persistent - A positive result detected in at least 2 consecutive post baseline samples separated by at least a 16-week post baseline period, with no negative results in-between. Indeterminate - A positive result at the last collection time point analyzed only. Transient - Not persistent or indeterminate regardless of any missing samples. Treatment boosted - any post-dose positive result at least 9-fold over the baseline level when baseline is positive.
Time Frame
16 Weeks
Title
Serum Concentration of Functional Fasinumab Over Time
Description
Summary of mean concentration of functional fasinumab are presented by nominal time point.
Time Frame
Baseline, Week 2, Week 4, Week 8, Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Regeneron Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Regeneron Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Regeneron Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Regeneron Research Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Regeneron Research Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Regeneron Research Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Regeneron Research Site
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Regeneron Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Regeneron Research Site
City
San Marcos
State/Province
California
ZIP/Postal Code
92078
Country
United States
Facility Name
Regeneron Research Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92703
Country
United States
Facility Name
Regeneron Research Site
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Regeneron Research Site
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Facility Name
Regeneron Research Site
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Regeneron Research Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Regeneron Research Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Regeneron Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Regeneron Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Regeneron Research Site
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Regeneron Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Regeneron Research Site
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Regeneron Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Regeneron Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Regeneron Research Site
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Regeneron Research Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Regeneron Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
Regeneron Research Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Regeneron Research Site #1
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Regeneron Research Site #2
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Regeneron Research Site
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Regeneron Research Site
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Regeneron Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Regeneron Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Regeneron Research Site
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
Regeneron Research Site
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Regeneron Research Site
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Regeneron Research Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Regeneron Research Site
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Regeneron Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Regeneron Research Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Regeneron Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Regeneron Research Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Regeneron Research Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Regeneron Research Site
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
Regeneron Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Regeneron Research Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Regeneron Research Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58105
Country
United States
Facility Name
Regeneron Research Site
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45431
Country
United States
Facility Name
Regeneron Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Regeneron Research Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Regeneron Research Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Regeneron Research Site #1
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Regeneron Research Site #2
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Regeneron Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Regeneron Research Site
City
Katy
State/Province
Texas
ZIP/Postal Code
77498
Country
United States
Facility Name
Regeneron Research Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Regeneron Research Site
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53144
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee

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