Healthy, Painful Lumbar Radiculopathy
Conditions
Keywords
Sciatica
Brief summary
The primary objective of the study is to evaluate the safety and tolerability of a range of single intravenous (IV) and subcutaneous (SC) doses of BG00010 in healthy volunteers, and a range of multiple SC doses of BG00010 in participants with painful lumbar radiculopathy. Secondary objectives of this study are to determine the single IV and SC dose pharmacokinetics (PK) profile of BG00010 in healthy volunteers including assessment of bioavailability by comparing SC exposure to IV exposure in each participant, to determine the multiple SC dose PK profiles of BG00010 in participants with painful lumbar radiculopathy, to assess the single IV and SC dose immunogenicity of BG00010 in healthy volunteers, to assess the multiple SC dose immunogenicity of BG00010 in participants with painful lumbar radiculopathy, and to assess the potential of BG00010 to reduce pain following multiple SC administrations in participants with painful lumbar radiculopathy.
Interventions
BIOLOGICALBG00010 IV
Ascending Doses intravenous (IV) of BG00010
BIOLOGICALBG00010 SC
Ascending Doses subcutaneous (SC) of BG00010
DRUGPlacebo IV
Ascending Doses intravenous (IV) of Placebo
DRUGPlacebo SC
Ascending Doses subcutaneous (SC) of placebo
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: Part I and Part II * Healthy Volunteers Key Inclusion Criteria: Part III multiple ascending dose (MAD) * Subjects must have a diagnosis of unilateral painful lumbar radiculopathy and painful lumbar radiculopathy symptoms must be present for 3 or more months prior to the Screening Visit. * Subjects must rate their pain at ≥40 mm on the 100 mm visual analog scale (VAS) of the short form McGill pain questionnaire (SF-MPQ) at the Screening and Baseline Visits. Key Inclusion Criteria for All Subjects for Part I, Part II, Part III: * All male subjects and all female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment. - Key
Exclusion criteria
for All Subjects for Part I, Part II, Part III: * History of or positive screening test for hepatitis C infection , hepatitis B infection, or positive for human immunodeficiency virus (HIV) antibody. Subjects who are hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (HBcAb) positive are allowed to participate if they are positive for HBsAb immunoglobulin G * History of malignancy or clinically relevant (as determined by the Investigator) allergies; cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (not related to painful lumbar radiculopathy), dermatologic, rheumatic/joint, psychiatric, renal, and/or other major disease. * Relevant history of illicit drug or alcohol abuse (as defined by the Investigator) within 1 year prior to the Screening Visit. - * Female subjects who are pregnant or currently breastfeeding, or who have a positive pregnancy test result at the Screening or Baseline Visits. * Previous administration of a neurotrophic factor, including BG00010. * Participation in a study with another investigational drug or approved therapy for investigational use within the 3 months prior to the Baseline Visit, or current enrollment in any other study. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of participants with Adverse Events (AEs)/Serious Adverse Events (SAEs) | Up to Day 75 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to maximum serum concentration (Tmax) of BG00010 | Pre-dose and up to 24 hours post-dose | — |
| Half life (t1/2) of BG00010 | Pre-dose and up to 24 hours post-dose | — |
| Area under the serum concentration time curve (AUC) from zero to infinity AUC(0-∞) for BG00010 | Pre-dose and up to 24 hours post-dose | — |
| Maximum observed concentration (Cmax) of BG00010 | Pre-dose and up to 24 hours post-dose | — |
| Number of participants with anti-BG00010 antibodies in serum | Up to Day 75 | — |
| Pain as measured by an 11-point numeric rating scale (NRS) | Up to Day 75 | The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. The scale ranges from 0 (no pain) to 10 (worst pain imaginable). |
| Pain as measured by short form McGill pain questionnaire (SF-MPQ) visual analog scale (VAS) | Up to Day 75 | A 10 cm visual analog scale ranging from 0 (no pain) to 10 (worst possible pain). |
| Subcutaneous (SC) bioavailability | Pre-dose and up to 24 hours post-dose | — |
Countries
Netherlands
Outcome results
None listed