A study to determine the efficacy and safety of fasinumab for the treatment of adults with lower back pain

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

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003782-28-DK

Enrollment

800

Registered

2016-02-08

Start date

2016-02-15

Completion date

Unknown

Last updated

2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain MedDRA version: 20.0 Level: PT Classification code 10003988 Term: Back pain System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: Fasinumab Product Code: REGN475 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Fasinumab CAS Number: 1190239-42-9 Current Sponsor code: REGN475 Ot

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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 (non-radiculopathic) 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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) NRS score. ;Secondary Objective: Secondary objectives of the study are to evaluate the efficacy of fasinumab compared to placebo as measured by: • Change from baseline in the RMDQ total score • Change from baseline in the PGA of LBP score • Change from baseline in the average daily LBPI NRS score;Primary end point(s): Change from baseline at week 16 in the average daily LBPI NRS score ;Timepoint(s) of evaluation of this end point: At week 16	—

Measure

Time frame

Main Objective: 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) NRS score. ;Secondary Objective: Secondary objectives of the study are to evaluate the efficacy of fasinumab compared to placebo as measured by: • Change from baseline in the RMDQ total score • Change from baseline in the PGA of LBP score • Change from baseline in the average daily LBPI NRS score;Primary end point(s): Change from baseline at week 16 in the average daily LBPI NRS score ;Timepoint(s) of evaluation of this end point: At week 16

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Secondary

Measure	Time frame
Secondary end point(s): 1. Change from baseline at week 16 in the RMDQ total score 2. Change from baseline at week 16 in the PGA of LBP score 3. Change from baseline at weeks 2, 4, 8, and 12 in the LBPI NRS Safety endpoints: 1. Percent of patients reporting treatment-emergent adverse events (TEAEs) 2. The incidence of anti-fasinumab antibody formation;Timepoint(s) of evaluation of this end point: At weeks 2, 4, 8, 12 and 16	—

Measure

Time frame

Secondary end point(s): 1. Change from baseline at week 16 in the RMDQ total score 2. Change from baseline at week 16 in the PGA of LBP score 3. Change from baseline at weeks 2, 4, 8, and 12 in the LBPI NRS Safety endpoints: 1. Percent of patients reporting treatment-emergent adverse events (TEAEs) 2. The incidence of anti-fasinumab antibody formation;Timepoint(s) of evaluation of this end point: At weeks 2, 4, 8, 12 and 16

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Countries

Canada, Czech Republic, Denmark, Estonia, Hungary, Poland, United States

Contacts

Public ContactClinical Trial Information

Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026