Trial · NCT05494619
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Participants With Guillain-Barré Syndrome (GBS)
NCT05494619, Phase 3, Withdrawn, Hoffmann-La Roche
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Participants With Guillain-Barré Syndrome (GBS). Trials, record NCT05494619. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05494619
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Participants With Guillain-Barré Syndrome (GBS)
- NCT number
- NCT05494619
- Status
- Withdrawn
- Phases
- Phase 3
- Enrollment
- 0 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Guillain-Barré Syndrome
- Interventions
- Crovalimab, Placebo, Intravenous immunoglobulin therapy
- First posted
- 2022-08-10
- Last updated
- 2022-12-15
- Other registries' IDs
- eudract:2021-002968-49
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants who Reach Hughes Functional Grade (FG) Score ≤ 1 on the Guillain-Barré Syndrome Disability Scale (GBS-DS) at Week 24 | Week 24 | The Guillain-Barré Syndrome disability score (GBS DS) is used to assess the degree of functional disability of study participants. The scale consists of seven grades of functional disability ranging from 0 (healthy with no symptoms attributable to GBS) to 6 (death). |
| Secondary | Time to Recover Independent Walking Assessed Using the 10-Meter Walk Test (10-MW) | Up to approximately 52 weeks | Defined as time from randomization to the first time point at which the participant is able to walk independently, assessed using the 10-MWT. |
| Secondary | Functional Outcome on GBS-DS at Week 8 | Week 8 | The Guillain-Barré Syndrome disability score (GBS DS) is used to assess the degree of functional disability of study participants. The scale consists of seven grades of functional disability ranging from 0 (healthy with no symptoms attributable to GBS) to 6 (death). |
| Secondary | Percentage of Inflammatory Rasch-Built Overall Disability Scale (I-RODS) Responders at Week 24 | Week 24 | Defined as a participant who is able to perform all activities assessed by the I-RODS with or without some difficulties (graded 1 or 2). I-RODs is a 24-item scale to rate a participant's general ability to function and complete activities of daily living. The items range in difficulty from very easy ("reading a newspaper/book" and "eating") to very difficult ("standing for hours" and "running"). The participant assigns a score between 0 and 3 (0: not possible, 1: possible with difficulty, 2: possible without any difficulty, 3: unable to perform before GBS \[option 3 only available at the baseline visit\]) to each item. |
| Secondary | Mean Post-Recovery Time | Randomization to Week 24 | Defined as the time from reaching FG ≤ 1 for the first time after randomization to Week 24 |
| Secondary | Duration of Ventilator Support | Randomization to Week 24 | |
| Secondary | Percentage of Participants with Treatment Emergent Adverse Events | Up to approximately 52 weeks | Adverse events severity was determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0) grading |
| Secondary | Percentage of Participants with Treatment Emergent Adverse Events Leading to Study Drug Discontinuation | Up to approximately 52 weeks | |
| Secondary | Percentage of Participants with Anti-Drug Antibodies to Crovalimab | Up to approximately 52 weeks | |
| Secondary | Serum Concentrations of Crovalimab | From Day 1 up to Week 52 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05494619
GET https://conductscience.org/api/trials/v1/NCT05494619/registered