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Trial record 3 of 63 for:    regeneron | Recruiting, Not yet recruiting, Available Studies

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

This study is not yet open for participant recruitment.
Verified September 2017 by Regeneron Pharmaceuticals
Sponsor:
ClinicalTrials.gov Identifier:
NCT03285646
First Posted: September 18, 2017
Last Update Posted: September 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
  Purpose
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 patients 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 patients 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 patients 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 patients with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip.

Condition Intervention Phase
Chronic Low Back Pain Osteoarthritis Drug: Fasinumab Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Change in the daily average Low back pain intensity (LBPI) Numerical Rating Scale (NRS) score . [ Time Frame: Week 16 ]
    In patients treated with fasinumab compared to patients treated with placebo


Secondary Outcome Measures:
  • Change in Roland Morris Disability Questionnaire (RMDQ) total score [ Time Frame: Week 16 ]
    In patients treated with fasinumab compared to patients treated with placebo

  • Change in Patient Global Assessment (PGA) of Low back pain (LBP) score [ Time Frame: Week 16 ]
    In patients treated with fasinumab compared to patients treated with placebo

  • Proportion of responders as defined by ≥30% reduction in daily average LBPI NRS score [ Time Frame: Week 16 ]
    In patients treated with fasinumab compared to patients treated with placebo

  • Change in the Brief Pain Inventory Short Form (BPI-sf) pain interference score [ Time Frame: Week 16 ]
    In patients treated with fasinumab compared to patients treated with placebo

  • Incidence of Adjudicated arthropathy (AA) [ Time Frame: Week 16 ]
  • Incidence of Destructive arthropathy (DA) [ Time Frame: Week 16 ]
  • Incidence of treatment-emergent adverse event (TEAEs) [ Time Frame: Up to 64 weeks ]
  • Incidence of Sympathetic nervous system (SNS) dysfunction [ Time Frame: Week 16 ]
  • Incidence of peripheral sensory AEs that require a neurology consultation [ Time Frame: Up to 64 weeks ]
  • Incidence of all-cause joint replacement (JR) surgeries [ Time Frame: Up to Week 36 ]
  • Incidence of JRs at telephone survey after last dose of study drug [ Time Frame: Up to 52 weeks ]

Estimated Enrollment: 1020
Anticipated Study Start Date: October 31, 2017
Estimated Study Completion Date: September 30, 2020
Estimated Primary Completion Date: August 31, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fasinumab
Subcutaneous (SC) every 4 weeks (Q4W)
Drug: Fasinumab
Subcutaneous (SC) every 4 weeks (Q4W)
Other Name: REGN475
Placebo Comparator: Placebo
SC every 4 weeks
Drug: Placebo
Subcutaneous (SC) every 4 weeks (Q4W)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 may apply.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03285646


Contacts
Contact: Clinical Trials Administer 844-734-6643 clinicaltrials@regeneron.com

Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03285646     History of Changes
Other Study ID Numbers: R475-PN-1612
2017-001943-12 ( EudraCT Number )
First Submitted: September 14, 2017
First Posted: September 18, 2017
Last Update Posted: September 18, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Regeneron Pharmaceuticals:
Knee
Hip

Additional relevant MeSH terms:
Osteoarthritis
Back Pain
Low Back Pain
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms