Guillain Barre Syndrome
Conditions
Interventions
crovalimab: Crovalimab will be administered at a dose of 1000 mg IV (for participants with body weight >= 40 kg and = 100 kg) on Day 1, followed by crovalimab 340 mg SC injections on Days 2, 8, 15 and
Sponsors
James Overell
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Body weight >= 40 kg at screening - Confirmed diagnosis of GBS according to NINDS classification system - Onset of weakness due to GBS within 2 weeks before randomization - Able to start the first dose of blinded study drug within 2 weeks of onset of weakness - Able to climb a flight of stairs prior to GBS - Unable to walk independently for >=10 meters (FG 3) with deteriorating weakness as per investigator judgment, or FG 4 or FG 5 on the Guillain-Barre Syndrome Disability Scale (GBS-DS) - Undergoing or starting IVIg treatment (400 mg/kg QD for 5 days) prior to first blinded study drug administration - A record of vaccination against Neisseria meningitidis, Haemophilus influenzae type B, and Streptococcus pneumonia - For female participants of childbearing potential: agreement to remain abstinent or use contraception
Exclusion criteria
Exclusion criteria: - Clear clinical and historical evidence of significant or disabling acute or chronic peripheral neuropathy of alternative etiology - History of requiring a permanent aid to walk prior to GBS - Treatment with plasmapheresis or PLEX after GBS diagnosis, or a plan to receive this treatment - Receipt of systemic immunosuppressive treatment within 4 weeks prior to randomization - History of Neisseria meningitidis infection within 12 months prior to screening and up to Day 1 - Any systemic bacterial, viral, or fungal infection ongoing at screening and up to Day 1 which, in the investigators' judgment, is active and could potentially be worsened by immunosuppression - For participants with prior exposure to anti-CD20 agents, most recent anti-CD20 treatment within 6 months prior to screening - Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within five half lives of that investigational product, whichever is longer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy - Percentage of participants who reach FG <= 1 on the GBS-DS at Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy - Time to recover independent walking - Functional outcome on GBS-DS at Week 8 - Percentage of Inflammatory Rasch-Built Overall Disability Scale (I-RODS) responders at Week 24 Safety, Phamacokinetics, Phamacodynamics - Percentage of participants with treatment emergent adverse events - Percentage of participants with adverse events leading to study drug discontinuation - Percentage of participants with anti-drug antibodies to crovalimab - Serum concentrations of crovalimab | — |
Countries
Australia, Canada, India, Italy, Japan, Mexico, Netherlands, Peru, South Korea, Spain, Turkey, United States
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed