A Phase 3 clinical trial (NCT05494619) investigating crovalimab (also known as Piasky) for the treatment of Guillain-Barré Syndrome (GBS) has been withdrawn. The trial's status was updated on ClinicalTrials.gov on 2026-03-19, indicating that no participants were ever enrolled in the study.
Background
The withdrawn study, titled "A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Participants With Guillain-Barré Syndrome (GBS)," aimed to assess crovalimab as an add-on therapy to intravenous immunoglobulin (IVIg). Crovalimab was intended to be evaluated for its potential in treating severe GBS.
Trial design
The study, identified as NCT05494619, was designed as a Phase 3 trial. It intended to investigate crovalimab compared with placebo as an add-on therapy to intravenous immunoglobulin therapy (IVIg) in participants with Guillain-Barré Syndrome. Despite its design, the trial reported an enrollment of 0 participants.
What this means
The withdrawal of this Phase 3 trial for crovalimab in Guillain-Barré Syndrome, coupled with zero participant enrollment, signifies that the study did not proceed to gather any clinical data. This cessation means there will be no efficacy or safety data from this specific trial to support the use of crovalimab for GBS, impacting its development pathway for this indication.
Source
The information regarding the withdrawal of this clinical trial was obtained from the study record for NCT05494619 on ClinicalTrials.gov, a public database of clinical studies. The status update was associated with a primary completion date of 2026-03-19 on clinicaltrials.gov.