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

• Register: EUCTR
• Last refreshed on: 9 October 2017
• Main ID: EUCTR2015-003782-28-HU
• Date of registration: 12/04/2016
• Prospective Registration: No
• Primary sponsor: Regeneron Pharmaceuticals, Inc.
• Public title: A study to determine the efficacy and safety of fasinumab for the treatment of adults with lower back pain
• Scientific title: 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
• Date of first enrolment: 11/04/2016
• Target sample size: 800
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003782-28
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Clinical Trial Information
• Affiliation: Regeneron Pharmaceuticals, Inc.

• Name: Clinical Trial Information
• Affiliation: Regeneron Pharmaceuticals, Inc.

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chronic Low Back Pain
MedDRA version: 19.0 Level: PT Classification code 10003988 Term: Back pain System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

Intervention(s)

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
Other descriptive name: FASINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 12-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

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
Other descriptive name: FASINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 18-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Product Name: Fasinumab
Product Code: REGN475
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Fasinumab
CAS Number: 1190239-42-9
Current Sponsor code: REGN475
Other descriptive name: FASINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6-
Pharmaceutical form of the placebo: Infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

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.

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

Secondary Outcome(s)

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

Secondary ID(s)

2015-003782-28-DK

R475-PN-1524

Source(s) of Monetary Support

Regeneron Pharmaceuticals, Inc.