The primary objective of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of 3 intravenous (IV) injections of BG00010 given on 2 fixed schedules; weekly and as frequently as every 48 hours (but no more than 3 times…
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints:
-the number and proportion of subjects with Adverse Events (AEs)
-the type and severity of AEs
-changes in clinical laboratory measurements
-pharmacokinetic (PK) parameters
Secondary outcome
Secondary endpoints:
-the incidence of anti-BG00010 antibodies
-changes in pain as measured by a Likert numerical pain rating scale and the
VAS of the SF-MPQ
Exploratory endpoints:
-Intra Epidermal Nerve Fiber Density (IENFD) in both affected and unaffected
leg to assess for change
-changes in pain thresholds as determined by longitudinal nociceptive testing
(electrical and mechanical pain, and cold pressor testing)
Background summary
BG00010 is a protein that interacts with sensory neurons in the peripheral
nervous system to alleviate neuropathic pain. BG00010 is being developed as a
treatment for conditions like sciatica that are associated with neuropathic
pain. This study expands on a previous study, which is a single ascending dose
(SAD) study in sciatica subjects, and will be the second study of BG00010 in
humans.
Study objective
The primary objective of the study is to evaluate the safety, tolerability, and
pharmacokinetic (PK) profile of 3 intravenous (IV) injections of BG00010 given
on 2 fixed schedules; weekly and as frequently as every 48 hours (but no more
than 3 times per week). Secondary objectives of this study in this study
population are to explore the repeated-dose immunogenicity of BG00010 and the
potential of BG00010 to reduce pain following multiple dose administration.
Study design
This will be a phase 1, randomized, blinded, placebo controlled, serial-cohort
study in sciatica subjects that will examine 2 dose schedules: Part I (once
weekly) and Part II (up to 3 times weekly).
Intervention
4 ascending IV doses will be examined (50, 150, 400, and 800 µg/kg). Dose
escalation will first occur in Part I (the once weekly group). Once escalation
is complete up to 800 µg/kg, or a maximum tolerated dose (MTD) is determined,
then the frequency of dosing will be increased (Part II). Subjects in both
Part I and Part II will receive no more than 3 IV injections of study drug.
Study burden and risks
Side-effects that are reported after use of BG00010 are headache, itchiness,
rash, feeling warm and pain in legs or arms. An immune reaction to BG00010 is
possible. Within animal studies, transient neuronal vacuolation was observed at
the highest dose levels. No exceptional severe adverse drug reactions are
expected and burden/inconvenience for the subjects are considered relatively
mild. Development of BG00010 could constitute an additional therapeutic tool
for the treatment of sciatica.
Biogen Idec Limited, Innovation House, 70 Norden Rd
Maidenhead, SL6 4AY
GB
Biogen Idec Limited, Innovation House, 70 Norden Rd
Maidenhead, SL6 4AY
GB
Listed location countries
Age
Inclusion criteria
1. Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information).
2. Must be aged 18 to 85 years old, inclusive, at the time of informed consent.
3. Must have a diagnosis of unilateral sciatica, determined by the Investigator including pain radiating down the leg following a dermatome, suggesting L4, L5, or S1 nerve root involvement. Sciatica symptoms must be present for 3 or more months prior to the Screening Visit.
4. Must rate their pain at >=40 mm on the 100 mm VAS of the SF-MPQ at the Screening and Baseline Visits.
5. All male subjects and all female subjects of child-bearing potential must practice effective contraception during the study and be willing and able to continue contraception for 2 months after their last dose of study treatment.
Exclusion criteria
Medical History
1. History of malignancy or clinically relevant (as determined by the Investigator) allergies; and/or cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (not related to sciatica), dermatologic, rheumatic/joint, psychiatric, renal, and/or other major disease.
2. History of severe pain as judged by the investigator, other than that caused by sciatica, during the 3 months prior to their screening visit
3. Signs or symptoms of peripheral neuropathy, other than symptoms of sciatica during the 3 months prior to screening
4. History of severe allergic or anaphylactic drug-related reactions.
5. Major surgery within the 3 months prior to the Screening Visit or planned sciatica surgery within 6 months of the Screening Visit.
6. Current generalized myalgia.
7. Fever (body temperature >38°C) or symptomatic viral or bacterial infection within 2 weeks prior to the Baseline Visit.
8. Laboratory value at the Screening or Baseline Visits that is outside the normal range, unless it is judged by the Investigator as not clinically relevant after appropriate evaluation.
9. Serum Creatinine clearance >1.5 x upper limit of normal (ULN).
10. History of or positive screening test for hepatitis C infection (defined as positive for hepatitis C virus antibody [HCVAb]), hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or positive for hepatitis B core antibody [HBcAb] at Screening), or positive for human immunodeficiency virus (HIV) antibody. Subjects who are HBsAg negative and HBcAb positive are allowed to participate if they are positive for HBsAb IgG (see the Centers for Disease Control and Prevention's interpretation of the hepatitis B serology panel; Appendix 28).
11. Clinically relevant abnormal electrocardiogram (ECG, 12-lead) at the Screening or Baseline Visits, as determined by the Investigator. Subjects who have a marked prolongation of the QT corrected (QTc) interval (i.e., repeated demonstration of a QTc interval >450 msec for females or >430 msec for males) at the Screening or Baseline Visits will not be allowed to enroll into the study.;Treatment History
12. Previous participation in a study with neurotrophic factors.
13. Participation in a study with another investigational drug or approved therapy for investigational use within the 3 months prior to the Baseline Visit.
14. Any immunization/vaccination within 1 month prior to the Baseline Visit.
15. Treatment with any prescription medication and/or over the-counter products such as herbal supplements, unless the dose has been stabilized prior to the Baseline Visit. Selective serotonin reuptake inhibitor, selective noradrenaline reuptake inhibitor, and tricyclic antidepressant doses must be stable for 4 weeks prior to the Baseline Visit. Gabapentin and pregabalin doses must be stable for 1 week prior to the Baseline Visit. ;Miscellaneous
16. Female subjects who are pregnant or currently breastfeeding, or who have a positive pregnancy test result at the Screening or Baseline Visits.
17. Relevant history of illicit drug or alcohol abuse (as determined by the Investigator) within 1 year of the Screening Visit. Subjects who have a positive urine drug test at the Screening or Baseline Visits may be enrolled at the discretion of the Investigator.
18. Blood donation (1 unit or more) within 1 month prior to the Screening Visit.
19. Smoke >5 cigarettes per day.
20. Current enrollment in any other study.
21. Any alcohol use within 24 hours prior to dosing on Day 01.
22. Vigorous exercise (i.e., greater than 30 minutes of aerobic exercise) within 48 hours prior to dosing on Day 01.
23. Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's returning for follow-up visits on schedule.
24. Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec Inc. (Biogen Idec), make the subject unsuitable for enrollment.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2011-000681-35-NL |
CCMO | NL36767.056.11 |