Low Back PainPhase 2/3NCT02620020

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

A Phase 2/3 study testing Fasinumab in people with Low Back Pain, run by Regeneron Pharmaceuticals at 74 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 35 years and older
Conditions the study is for: Low Back Pain
What is being tested?: Fasinumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 563 participants
Where: 74 sitesin 7 countries
Study dates: 26 Jan 2016to 13 Sep 2017
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

74 sites in 7 countries.

Country

City, postcode or hospital

74 sites in 7 countries

United States58 sites

Study site
Akron, Ohio
Study site
Anderson, South Carolina
Study site
Aurora, Colorado
Study site
Beverly Hills, California
Study site
Birmingham, Alabama
Study site
Bristol, Tennessee
Study site
Carlsbad, California
Study site
Cary, North Carolina
Study site
Chandler, Arizona
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Clearwater, Florida
Study site
Colorado Springs, Colorado
Study site
Columbus, Ohio
Study site
Council Bluffs, Iowa
Study site
Cypress, Texas
Study site
Dallas, Texas
Study site
Duncansville, Pennsylvania
Study site
Edina, Minnesota
Study site
Elkhorn, Nebraska
Study site
Evansville, Indiana
Study site
Fort Myers, Florida
Study site
Glendale, Arizona
Study site
Greer, South Carolina
Study site
Henderson, Nevada
Study site
High Point, North Carolina
Study site
Jamaica, New York
Study site
Kansas City, Missouri
Study site
Knoxville, Tennessee
Study site
Lakewood, California
Study site
Las Vegas, Nevada
Study site
Leesburg, Florida
Study site
Little Rock, Arkansas
Study site
Littleton, Colorado
Study site
Long Beach, California
Study site
Lubbock, Texas
Study site
Mesa, Arizona
Study site
Miami, Florida
Study site
New York, New York
Study site
Oklahoma City, Oklahoma
Study site
Orlando, Florida
Study site
Phoenix, Arizona
Study site
Plano, Texas
Study site
Raleigh, North Carolina
Study site
Sacramento, California
Study site
Salisbury, North Carolina
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
Santa Rosa, California
Study site
Scottsdale, Arizona
Study site
St Louis, Missouri
Study site
Tucson, Arizona
Study site
Vista, California
Study site
Washington D.C., District of Columbia
Study site
Williamsville, New York
Study site
Wilmington, North Carolina
Study site
Worcester, Massachusetts

Other trials in United States

Poland6 sites

Study site
Bialystok
Study site
Lodz
Study site
Lublin
Study site
Rzeszów
Study site
Warsaw
Study site
Zgierz

Other trials in Poland

Hungary3 sites

Study site
Budapest
Study site
Gyula
Study site
Szolnok

Other trials in Hungary

Canada2 sites

Study site
London, Ontario
Study site
Toronto, Ontario

Other trials in Canada

Czechia2 sites

Study site
Prague
Study site
Rychnov nad Kněžnou

Other trials in Czechia

Denmark2 sites

Study site
Aalborg
Study site
Ballerup Municipality

Other trials in Denmark

Estonia1 site

Study site
Tallinn

Other trials in Estonia

About this study

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

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

Conditions: Low Back Pain
Being tested: Fasinumab, placebo
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FasinumabDrug
Also called REGN475
Participants received fasinumab SC or IV, Q4W or Q8W.
placeboDrug
Participants received placebo matching to fasinumab SC or IV, Q4W or Q8W.

Study groups in NCT02620020
Study group	Role	What they receive
Fasinumab 6 mg SC Q4W and Placebo IV Q8W	Experimental	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. Receives: Drug: Fasinumab; Drug: placebo
Fasinumab 9 mg SC Q4W and Placebo IV Q8W	Experimental	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. Receives: Drug: Fasinumab; Drug: placebo
Fasinumab 9 mg IV Q8W and Placebo SC Q4W	Experimental	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. Receives: Drug: Fasinumab; Drug: placebo
Placebo SC Q4W and Placebo IV Q8W	Experimental	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. Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to Week 16 in the Average Daily Low Back Pain Index Numeric Rating Scale (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.
Measured: Baseline to Week 16

Secondary outcomes (3)

Change From Baseline to Weeks 2, 4, 8, and 12 in the Average Low Back Pain Index Numeric Rating Scale Score (LBPI NRS)
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.
Measured: Baseline to Weeks 2, 4, 8, and 12
Change From Baseline to Week 16 in Roland Morris Disability Questionnaire (RMDQ) Total Score
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.
Measured: Baseline to Week 16
Change From Baseline to Week 16 in the 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 0-5 where 1=very well; 2=well; 3=fair; 4=poor; and 5=very poor.
Measured: Baseline to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jan 201613 Sep 2017

First posted2 Dec 2015 (estimated)
Study start26 Jan 2016
Primary completion3 Feb 2017
Study completion13 Sep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Low Back PainStudies of the same condition, open and under way.
More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 563 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02620020
Sponsor's protocol ID: R475-PN-1524
Other IDs: 2015-003782-28, 2015
Status last verified: Jun 2020
First submitted: 30 Nov 2015
Last updated: 16 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02620020
Acronym / sponsor ID: R475-PN-1524
Conditions: Low Back Pain
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 563 participants (actual)
Lead sponsor: Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 26 Jan 2016 (actual)
Primary completion: 3 Feb 2017 (actual)
Study completion: 13 Sep 2017 (actual)
First posted: 2 Dec 2015 (estimated)
Results: Posted 1 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Fasinumab 6 mg SC Q4W and Placebo IV Q8W	Experimental	Drug: Fasinumab, Drug: placeboParticipants 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.
Fasinumab 9 mg SC Q4W and Placebo IV Q8W	Experimental	Drug: Fasinumab, Drug: placeboParticipants 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.
Fasinumab 9 mg IV Q8W and Placebo SC Q4W	Experimental	Drug: Fasinumab, Drug: placeboParticipants 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.
Placebo SC Q4W and Placebo IV Q8W	Experimental	Drug: placeboParticipants 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.

Who may qualify

Ages: 35 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FasinumabAlso: REGN475Participants received fasinumab SC or IV, Q4W or Q8W.	Drug	Fasinumab 6 mg SC Q4W and Placebo IV Q8W, Fasinumab 9 mg IV Q8W and Placebo SC Q4W, Fasinumab 9 mg SC Q4W and Placebo IV Q8W
placeboParticipants received placebo matching to fasinumab SC or IV, Q4W or Q8W.	Drug	Fasinumab 6 mg SC Q4W and Placebo IV Q8W, Fasinumab 9 mg IV Q8W and Placebo SC Q4W, Fasinumab 9 mg SC Q4W and Placebo IV Q8W, Placebo SC Q4W and Placebo IV Q8W

Primary outcome

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.

3 secondary outcomes

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
Change From Baseline to Week 16 in Roland Morris Disability Questionnaire (RMDQ) Total Score
Time frame: Baseline to Week 16
Change From Baseline to Week 16 in the Patient Global Assessment (PGA) of Low Back Pain (LBP) Score
Time frame: Baseline to Week 16

Results and safety

Results posted to the registry on 1 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo SC Q4W and Placebo IV Q8W	141	97
Fasinumab 6 mg SC Q4W and Placebo IV Q8W	141	106
Fasinumab 9 mg SC Q4W and Placebo IV Q8W	140	115
Fasinumab 9 mg IV Q8W and Placebo SC Q4W	141	115

Primary outcome: 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. Least squares mean (Standard Error). Unit: Scores on a scale

Measure	Placebo SC Q4W and Placebo IV Q8W n = 140	Fasinumab 6 mg SC Q4W and Placebo IV Q8W n = 139	Fasinumab 9 mg SC Q4W and Placebo IV Q8W n = 139	Fasinumab 9 mg IV Q8W and Placebo SC Q4W n = 140
Value	-1.7 (0.23)	-2.0 (0.23)	-2.5 (0.22)	-2.4 (0.22)

Placebo SC Q4W and Placebo IV Q8W vs Fasinumab 6 mg SC Q4W and Placebo IV Q8W: Least Squares (LS) Mean Difference: -0.3 (95% CI -0.88 to 0.34), p = 0.3876, Mixed Models Analysis
Placebo SC Q4W and Placebo IV Q8W vs Fasinumab 9 mg SC Q4W and Placebo IV Q8W: LS Mean Difference: -0.7 (95% CI -1.32 to -0.12), p = 0.0180, Mixed Models Analysis
Placebo SC Q4W and Placebo IV Q8W vs Fasinumab 9 mg IV Q8W and Placebo SC Q4W: LS Mean Difference: -0.7 (95% CI -1.26 to -0.07), p = 0.0288, Mixed Models Analysis

Population analysed: Analysis performed on modified intent to treat set (mITT) included all randomized participants who received at least one dose of study drug based on the treatment allocated (as randomized) including data up to 5 weeks after the last dose of study drug. Number of participants analyzed = participants with available data for specified time point.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo SC Q4W and Placebo IV Q8W	4 of 140 (2.9%)	44 of 140 (31.4%)	0 of 140
Fasinumab 6 mg SC Q4W and Placebo IV Q8W	2 of 139 (1.4%)	35 of 139 (25.2%)	1 of 139
Fasinumab 9 mg SC Q4W and Placebo IV Q8W	3 of 139 (2.2%)	52 of 139 (37.4%)	0 of 139
Fasinumab 9 mg IV Q8W and Placebo SC Q4W	5 of 140 (3.6%)	49 of 140 (35%)	0 of 140

Limitations and caveats (from the sponsor): FDA placed study on partial clinical hold. Sponsor did not amend the protocol and enrollment and dosing were not resumed. However randomized participants completed all remaining study visits/procedures per protocol except for dosing.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trial Management study director

Regeneron Pharmaceuticals

74 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Fasinumab in people with Low Back Pain, run by Regeneron Pharmaceuticals at 74 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Poland, Hungary, Canada, Czechia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02620020.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.