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A Study to Determine the Efficacy and Safety of Fasinumab for the Treatment of Adults With Chronic Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02620020
Recruitment Status : Completed
First Posted : December 2, 2015
Results First Posted : August 1, 2019
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:

The main objective of the trial is to evaluate the efficacy of fasinumab compared to placebo as measured by the change from baseline in the average daily Low Back Pain Intensity (LBPI) Numerical Rating Scale (NRS).

Secondary objectives of the study are to evaluate the efficacy of fasinumab compared to placebo as measured by:

  • Change from baseline in the Roland Morris disability questionnaire (RMDQ) total score
  • Change from baseline in the Patient Global Assessment (PGA) of Low Back Pain (LBP) score
  • Change from baseline in the average daily LBPI NRS score

Condition or disease Intervention/treatment Phase
Low Back Pain Drug: Fasinumab Drug: placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 563 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multi-dose, Placebo-controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate to Severe Chronic Low Back Pain
Actual Study Start Date : January 26, 2016
Actual Primary Completion Date : February 3, 2017
Actual Study Completion Date : September 13, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Fasinumab 6 mg SC Q4W and Placebo IV Q8W
Participants randomized to the fasinumab 6 mg SC Q4W arm received fasinumab 12 mg SC on Day 1 (loading dose) and then 6 mg SC (planned maintenance dose) at Weeks 4, 8, and 12 for a total of 4 doses. Matching placebo was received via intravenous (IV) infusion Q8W on Day 1 and at Week 8.
Drug: Fasinumab
Participants received fasinumab SC or IV, Q4W or Q8W.
Other Name: REGN475

Drug: placebo
Participants received placebo matching to fasinumab SC or IV, Q4W or Q8W.

Experimental: Fasinumab 9 mg SC Q4W and Placebo IV Q8W
Participants randomized to the fasinumab 9 mg SC Q4W arm received 18 mg SC on day 1 (loading dose) and then 9 mg SC (planned maintenance dose) at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo IV Q8W was received on Day 1 and at Week 8.
Drug: Fasinumab
Participants received fasinumab SC or IV, Q4W or Q8W.
Other Name: REGN475

Drug: placebo
Participants received placebo matching to fasinumab SC or IV, Q4W or Q8W.

Experimental: Fasinumab 9 mg IV Q8W and Placebo SC Q4W
Participants randomized to the fasinumab 9 mg IV Q8W arm received IV infusions of fasinumab 9 mg on Day 1 and Week 8, for a total of 2 doses. Matching placebo SC Q4W was received on day 1 and at weeks 4, 8, and 12.
Drug: Fasinumab
Participants received fasinumab SC or IV, Q4W or Q8W.
Other Name: REGN475

Drug: placebo
Participants received placebo matching to fasinumab SC or IV, Q4W or Q8W.

Experimental: Placebo SC Q4W and Placebo IV Q8W
Participants randomized to the matching placebo subcutaneously (SC) every four weeks (Q4W) arm received SC placebo in a manner similar to the SC loading dose of the active groups (placebo loading dose) on Day 1 and then an SC injection of placebo at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo intravenously (IV) every 8 weeks (Q8W) was received on Day 1 and at Week 8.
Drug: placebo
Participants received placebo matching to fasinumab SC or IV, Q4W or Q8W.




Primary Outcome Measures :
  1. Change From Baseline to Week 16 in the Average Daily Low Back Pain Index Numeric Rating Scale (LBPI NRS) Score [ Time Frame: Baseline to Week 16 ]
    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 :
  1. Change From Baseline to Weeks 2, 4, 8, and 12 in the Average Low Back Pain Index Numeric Rating Scale Score (LBPI NRS) [ Time Frame: Baseline to Weeks 2, 4, 8, and 12 ]
    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.

  2. Change From Baseline to Week 16 in Roland Morris Disability Questionnaire (RMDQ) Total Score [ Time Frame: Baseline to Week 16 ]
    The RMDQ is a self-administered, widely used 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 - that is from a minimum of 0 (no disability) to a maximum of 24 (maximum disability), where lower scores indicative of better function.

  3. Change From Baseline to Week 16 in the Patient Global Assessment (PGA) of Low Back Pain (LBP) Score [ Time Frame: Baseline to Week 16 ]
    The PGA of LBP is a participant assessed 5 point Likert scale of LBP ranging from 0-5 where 1=very well; 2=well; 3=fair; 4=poor; and 5=very poor.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Male or female ≥35 years of age at the screening visit
  2. Clinical diagnosis of chronic moderate to severe LBP (nonradiculopathic)for ≥3 months
  3. History of regular analgesic medication
  4. History of inadequate pain relief or intolerance to analgesics used for chronic LBP
  5. Willing to discontinue current pain medication

Key Exclusion Criteria:

  1. History of lumbosacral radiculopathy within the past 2 years
  2. Evidence on baseline lumbar spine magnetic resonance imaging of potentially confounding conditions
  3. Recent use of longer acting pain medications
  4. Evidence of destructive arthropathy
  5. Other medical conditions that may interfere with participation or accurate assessments during the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620020


  Show 74 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Regeneron Pharmaceuticals:
Study Protocol  [PDF] August 26, 2016
Statistical Analysis Plan  [PDF] March 20, 2017


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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02620020     History of Changes
Other Study ID Numbers: R475-PN-1524
2015-003782-28 ( EudraCT Number )
First Posted: December 2, 2015    Key Record Dates
Results First Posted: August 1, 2019
Last Update Posted: August 1, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Fasinumab
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs