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

Phase 1

Conditions: Chronic Low Back Pain
MedDRA version: 19.0Level: PTClassification code 10003988Term: Back painSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

Registration Number: EUCTR2015-003782-28-PL

Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 800

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Secondary objectives of the study are to evaluate the efficacy of fasinumab compared to placebo as measured by:<br>• Change from baseline in the RMDQ total score<br>• Change from baseline in the PGA of LBP score<br>• 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<br>;Timepoint(s) of evaluation of this end point: At week 16;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.<br>

Secondary Outcome Measures

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