Trial · NCT04035135
A Clinical Study of ANX005 and IVIG in Subjects With Guillain Barré Syndrome (GBS)
NCT04035135, Phase 1, Completed, Annexon, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Study of ANX005 and IVIG in Subjects With Guillain Barré Syndrome (GBS). Trials, record NCT04035135. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04035135
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Study of ANX005 and IVIG in Subjects With Guillain Barré Syndrome (GBS)
- NCT number
- NCT04035135
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 14 participants, actual
- Lead sponsor
- Annexon, Inc.
- Conditions
- Guillain-Barré Syndrome
- Interventions
- ANX005, Intravenous immunoglobulin
- First posted
- 2019-07-29
- Last updated
- 2021-08-11
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and tolerability of ANX005 when administered in combination with IVIg: incidence of TEAEs, SAEs, AE's | 6 months | As measured by incidence of TEAEs, SAEs, AE's related to ANX005, SAE's related to ANX005, Grade 3 or higher AEs, Grade 3 or higher AEs related to ANX005, AEs leading to study or treatment discontinuation. |
| Secondary | Pharmacokinetics of ANX005 when administered in combination with IVIg | 3 months | As measured by ANX005 serum concentrations |
| Secondary | Pharmacodynamics of ANX005 when administered in combination with IVIg | 4 months | As measured by CH50 and C1q serum concentrations |
| Secondary | Values and change from baseline in Guillain-Barré Syndrome Disability Score (GBS-DS) by visit | 6 months | The 6-point Guillain-Barré Syndrme Disability Score (GBS-DS) is a widely accepted and easily obtainable scoring system used to assess functional status of GBS subjects. The score is as follows: 0 = Healthy, 1 = Minor symptoms and capable of running, 2 = Able to walk independently 10 meters or more but unable to run, 3=Able to walk more than 10 meters across an open space with help, 4 = Bedridden or chair bound, 5 = Needing mechanical ventilation, 6 = death |
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/NCT04035135
GET https://conductscience.org/api/trials/v1/NCT04035135/registered