NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2061220061

Registered date:01/10/2022

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Participants with Guillain-Barre Syndrome

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedGuillain Barre Syndrome
Date of first enrollment04/10/2022
Target sample size154
Countries of recruitmentAustralia,Japan,Canada,Japan,India,Japan,Italy,Japan,Mexico,Japan,Netherlands,Japan,Peru,Japan,South Korea,Japan,Spain,Japan,Turkey,Japan,United States,Japan
Study typeInterventional
Intervention(s)crovalimab: Crovalimab will be administered at a dose of 1000 mg IV (for participants with body weight >= 40 kg and < 100 kg) or 1500 mg IV (for participants with body weight >= 100 kg) on Day 1, followed by crovalimab 340 mg SC injections on Days 2, 8, 15 and 22 in all participants.

Outcome(s)

Primary OutcomeEfficacy - Percentage of participants who reach FG <= 1 on the GBS-DS at Week 24
Secondary OutcomeEfficacy - 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

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include 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
Exclude 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

Related Information

Contact

Public contact
Name Clinical trials information
Address 1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo Tokyo Japan 103-8324
Telephone +81-120-189-706
E-mail clinical-trials@chugai-pharm.co.jp
Affiliation Chugai Pharmaceutical Co., Ltd.
Scientific contact
Name James Overell
Address 1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo Tokyo Japan 103-8324
Telephone +81-120-189-706
E-mail clinical-trials@chugai-pharm.co.jp
Affiliation F. Hoffmann-La Roche Ltd