215ON201 BIIB033 In Acute Optic Neuritis (AON) (RENEW)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Biogen Idec Australia Pty Ltd
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01721161
First received: October 25, 2012
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

The primary objective of the study is to evaluate the efficacy of BIIB033 in subjects with their first episode of unilateral Acute Optic Neuritis (AON). The secondary objective of this study in this study population is to assess the safety, tolerability, and pharmacokinetics (PK) of BIIB033.


Condition Intervention Phase
Acute Optic Neuritis
Biological: BIIB033
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With First Episode of Acute Optic Neuritis

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by full-field visual evoked potential (FF-VEP). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in thickness of the retinal nerve fiber layer (RNFL) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by spectral-domain optical coherence tomography (SD-OCT). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in thicknesses of the retinal ganglion cell layer/inner plexiform retinal layer (RGCL/IPL) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by segmentation of SD-OCT. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in low-contrast letter acuity (LCLA) at Week 24 from baseline as determined by 1.25% and 2.5% low contrast Sloan letter charts. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Number of participants with Adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 32 weeks ] [ Designated as safety issue: Yes ]
  • PK Parameters will be estimated based on Population based PK modeling. [ Time Frame: Up to 32 weeks ] [ Designated as safety issue: No ]
    One pre-dose PK sample and 1 post-dose PK sample (approximately between 1 and 3 hours after the end of IV infusion) will be collected for ALL participants on Day 1 and at Weeks 4 through 20 (every 4 weeks). Additionally, only 1 PK sample will be collected at Week 24 and Week 32.


Enrollment: 82
Study Start Date: December 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIIB033
Participants will receive BIIB033 once every 4 weeks for 20 weeks (a total of 6 doses).
Biological: BIIB033
100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses).
Placebo Comparator: Placebo
Participants will receive Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses).
Drug: Placebo
via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Ability to provide written consent and any authorization required by law.
  • Confirmed diagnosis of Acute Optic Neuritis (AON)
  • All male or female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment.

Key Exclusion Criteria:

  • Prior episode(s) of optic neuritis or loss of vision not due to AON.
  • Subjects with an established diagnosis of Multiple Sclerosis are excluded except if newly diagnosed based on the current episode of AON and positive brain MRI results consistent with the 2010 revisions to the McDonald's criteria.
  • Previous history of a clinically significant disease.
  • Females who have a positive pregnancy test result, or who are pregnant, breastfeeding, or planning to conceive during the study.
  • History of human immunodeficiency virus (HIV), hepatitis C virus antibody, or hepatitis B virus.
  • History or evidence of drug or alcohol abuse within 2 years prior to Screening.
  • Current enrollment in any other study treatment or disease study within 3 months prior to Day 1/Baseline.

NOTE: Other protocol defined criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721161

  Show 39 Study Locations
Sponsors and Collaborators
Biogen Idec
Biogen Idec Australia Pty Ltd
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01721161     History of Changes
Other Study ID Numbers: 215ON201
Study First Received: October 25, 2012
Last Updated: May 19, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Spain: Spanish Agency for Medicines and Health Products
Australia: Department of Health and Ageing Therapeutic Goods Administration
Italy: The Italian Medicines Agency
Czech Republic: State Institute for Drug Control
Sweden: Medical Products Agency
Hungary: National Institute of Pharmacy
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Paul-Ehrlich-Institut

Keywords provided by Biogen Idec:
Optic Neuritis

Additional relevant MeSH terms:
Neuritis
Optic Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases

ClinicalTrials.gov processed this record on October 01, 2014