Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee (FACT CLBP 1)

Regeneron Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Chronic Low Back Pain; Osteoarthritis

Treatments: Drug: Placebo; Drug: Fasinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03285646

2017-001943-12 (EudraCT Number)

R475-PN-1612

Details and patient eligibility

About

The primary objective of the study is to evaluate the efficacy of fasinumab in relieving Chronic low back pain (CLBP) as compared to placebo in participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and Osteoarthritis (OA) of the knee or hip when treated for up to 16 weeks. The secondary objectives of the study are: To evaluate the safety and tolerability of fasinumab compared to placebo when participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip are treated for up to 16 weeks; To characterize the concentrations of fasinumab in serum over time when participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip are treated for up to 16 weeks; To evaluate the immunogenicity of fasinumab when treated for up to 16 weeks in participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Clinical diagnosis of non-radicular moderate-to-severe CLBP for ≥3 months (prior to screening visit)
2. Clinical diagnosis of OA in at least 1 hip or knee joint based on the American College of Rheumatology Criteria with radiographic evidence of OA (K-L ≥2) at screening
3. History of inadequate relief of CLBP from non-pharmacologic therapy
4. Willing to undergo joint replacement (JR) surgery, if necessary
5. History of regular analgesic medication use
6. History of inadequate pain relief or intolerance to analgesics used for chronic LBP

Key Exclusion Criteria:

1. Patient is not a candidate for MRI
2. History of major trauma or back surgery in the past 6 months prior to the screening visit
3. History or presence of pyriformis syndrome
4. Evidence on baseline lumbar spine magnetic resonance imaging of potentially confounding conditions
5. History or evidence on joint imaging of conditions that may confound joint safety evaluation
6. Evidence or symptoms consistent with autonomic dysfunction (e.g., orthostatic hypotension and/or autonomic symptoms) as defined in the protocol
7. Recent use of longer acting pain medications
8. Other medical conditions that may interfere with participation or accurate assessments during the trial

Note: Other protocol defined Inclusion/ Exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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63 participants in 2 patient groups

Fasinumab

Experimental group

Description:

Subcutaneous (SC) every 4 weeks (Q4W)

Treatment:

Drug: Fasinumab

Placebo

Experimental group

Description:

SC every 4 weeks

Treatment:

Drug: Placebo