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Crovalimab for Guillain-Barré Syndrome

Phase 3

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 1 up to week 52

Awards & highlights

Study Summary

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of crovalimab compared with placebo as an add-on therapy to intravenous immunoglobulin (IVIg) in participants with severe GBS.

Eligible Conditions

Guillain-Barré Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 1 up to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 1 up to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 up to week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Guillain-Barre Syndrome

Secondary outcome measures

Duration of Ventilator Support

Functional Outcome on GBS-DS at Week 8

Mean Post-Recovery Time

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CrovalimabExperimental Treatment2 Interventions

Participants will receive a single intravenous (IV) infusion of crovalimab on Day 1 based on body weight, followed by crovalimab subcutaneous (SC) injection on Days 2, 8, 15, and 22 for a total of 4 weeks. Additionally, intravenous immunoglobulin (IVIg) background therapy will be administered once a day (QD) for 5 days.

Group II: PlaceboPlacebo Group2 Interventions

Participants will receive a single IV infusion of placebo on Day 1 based on body weight, followed by placebo SC injections on Days 2, 8, 15, and 22 for a total of 4 weeks. Additionally, IVIg background therapy will be administered QD for 5 days.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,431 Previous Clinical Trials

1,090,068 Total Patients Enrolled

Chugai Pharmaceutical Co., Ltd. (Sponsor in Taiwan and Japan)UNKNOWN

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,940 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Crovalimab undergone evaluation by the FDA?

"Crovalimab has been studied in multiple Phase 3 trials, so it is considered safe and has some data supporting efficacy."

Answered by AI

Are volunteers still being taken in for this research project?

"This trial, as indicated by its listing on clinicaltrials.gov, is still recruiting patients. The original posting was on 11/30/2022, with the most recent update being on 10/28/2022."

Answered by AI

How many people are able to sign up for this clinical trial at most?

"That is correct. The clinical trial in question, which was originally posted on November 30th, 2020, is currently recruiting patients. 154 individuals are needed for the study taking place across 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Participants With Guillain-Barré Syndrome (GBS)

2022. "A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Participants With Guillain-Barré Syndrome (GBS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05494619.