BIIB033 In Acute Optic Neuritis (AON)
Summary
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 is to assess the safety, tolerability, and pharmacokinetics (PK) of BIIB033 in this study population.
Timeline
- Start
- 2012-12
- Primary completion
- 2014-10
- Completion
- 2014-10
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry Placebo vs BIIB033; p = 0.3337; Difference -3.48 (95% CI -10.61 to 3.65); ANCOVA reads as missed primary endpoint NCT01721161 ↗
paper Remyelination did not differ significantly between the opicinumab and placebo groups in the ITT population at week 24. reads as missed primary endpoint PMID 28229892 ↗
release “Results from RENEW showed improved latency recovery, as measured by the primary endpoint full-field visual evoked potential (FF-VEP), among opicinumab participants, compared with placebo.” reads as met primary endpoint biogen.com ↗
Publications
- Klistorner A, Chai Y, Leocani L, Albrecht P, Aktas O, Butzkueven H, Ziemssen T, Ziemssen F, Frederiksen J, Xu L, Cadavid D; RENEW MF-VEP Investigators. Assessment of Opicinumab in Acute Optic Neuritis Using Multifocal Visual Evoked Potential. CNS Drugs. 2018 Dec;32(12):1159-1171. doi: 10.1007/s40263-018-0575-8.
- Petrillo J, Balcer L, Galetta S, Chai Y, Xu L, Cadavid D. Initial Impairment and Recovery of Vision-Related Functioning in Participants With Acute Optic Neuritis From the RENEW Trial of Opicinumab. J Neuroophthalmol. 2019 Jun;39(2):153-160. doi: 10.1097/WNO.0000000000000697.
- Cadavid D, Balcer L, Galetta S, Aktas O, Ziemssen T, Vanopdenbosch L, Frederiksen J, Skeen M, Jaffe GJ, Butzkueven H, Ziemssen F, Massacesi L, Chai Y, Xu L, Freeman S; RENEW Study Investigators. Safety and efficacy of opicinumab in acute optic neuritis (RENEW): a randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2017 Mar;16(3):189-199. doi: 10.1016/S1474-4422(16)30377-5. Epub 2017 Feb 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | opicinumab | Protein / enzyme biologic | 100 mg/kg | Intravenous |