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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02620020
• Other study ID #: R475-PN-1524
• Secondary ID: 2015-003782-28
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 26, 2016
• Est. completion date: September 13, 2017

Study information

• Verified date: June 2020
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 563
• Est. completion date: September 13, 2017
• Est. primary completion date: February 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Denmark,  Estonia,  Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to Week 16
Secondary	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.	Baseline to Weeks 2, 4, 8, and 12
Secondary	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.	Baseline to Week 16
Secondary	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.	Baseline to Week 16