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

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 3; Phase 2

Conditions: Low Back Pain

Treatments: Drug: Fasinumab; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02620020

2015-003782-28 (EudraCT Number)

R475-PN-1524

Details and patient eligibility

About

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

Enrollment: 563 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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563 participants in 4 patient groups

Fasinumab 6 mg SC Q4W and Placebo IV Q8W

Experimental group

Description:

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.

Treatment:

Drug: placebo

Drug: Fasinumab

Fasinumab 9 mg SC Q4W and Placebo IV Q8W

Experimental group

Description:

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.

Treatment:

Drug: placebo

Drug: Fasinumab

Fasinumab 9 mg IV Q8W and Placebo SC Q4W

Experimental group

Description:

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.

Treatment:

Drug: placebo

Drug: Fasinumab

Placebo SC Q4W and Placebo IV Q8W

Experimental group

Description:

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.

Treatment:

Drug: placebo