NCT04701164 is a Phase 3 clinical trial of ANX005 in Guillain-Barre Syndrome, sponsored by Annexon, Inc..

Who is sponsoring NCT04701164?

NCT04701164 is sponsored by Annexon, Inc..

What drugs are being tested in NCT04701164?

Interventions in NCT04701164: ANX005, Placebo.

What condition does NCT04701164 study?

NCT04701164 studies Guillain-Barre Syndrome.

Is NCT04701164 still recruiting?

NCT04701164 is currently completed. Last updated 29 May 2025.

Last reviewed 2025-05-29 · How we verify

NCT04701164

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy and Safety of ANX005 in Subjects With Guillain-Barré Syndrome

Completed Phase 3 Last updated 29 May 2025

What this trial tests

Phase 3 trial testing ANX005 in Guillain-Barre Syndrome in 242 participants. Completed in 20 April 2024.

Timeline

17 December 2020

Primary endpoint
20 April 2024

20 April 2024

Quick facts

Lead sponsor	Annexon, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	242
Start date	17 December 2020
Primary completion	20 April 2024
Estimated completion	20 April 2024
Sites	11 locations across Philippines, Bangladesh

Drugs / interventions tested

ANX005 — full drug profile →
Placebo

Conditions studied

Guillain-Barre Syndrome — all drugs for Guillain-Barre Syndrome →

Sponsor

Annexon, Inc. — full company profile →

Who can join

16 and older, any sex, with Guillain-Barre Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is intended to evaluate the efficacy and safety of ANX005 administered by intravenous (IV) infusion to participants recently diagnosed with Guillain-Barré Syndrome (GBS). The total duration of study participation is approximately 6 months.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Antibodies to watch in 2025.
Crescioli S, Kaplon H, Wang L, Visweswaraiah J, et al · · 2025 · cited 87× · PMID 39711140 · DOI 10.1080/19420862.2024.2443538
Current and Possible Future Therapeutic Options for Huntington's Disease.
Ferguson MW, Kennedy CJ, Palpagama TH, Waldvogel HJ, et al · · 2022 · cited 66× · PMID 35615642 · DOI 10.1177/11795735221092517
Novel Immunological and Therapeutic Insights in Guillain-Barré Syndrome and CIDP.
Querol L, Lleixà C. · · 2021 · cited 41× · PMID 34549385 · DOI 10.1007/s13311-021-01117-3
C1q and central nervous system disorders.
Zhang W, Chen Y, Pei H. · · 2023 · cited 33× · PMID 37033981 · DOI 10.3389/fimmu.2023.1145649
The Role of the Complement System in Chronic Inflammatory Demyelinating Polyneuropathy: Implications for Complement-Targeted Therapies.
Querol LA, Hartung HP, Lewis RA, van Doorn PA, et al · · 2022 · cited 33× · PMID 35378684 · DOI 10.1007/s13311-022-01221-y
Immunoglobulin and Monoclonal Antibody Therapies in Guillain-Barré Syndrome.
Rajabally YA. · · 2022 · cited 20× · PMID 35648286 · DOI 10.1007/s13311-022-01253-4
Results From a Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ANX005, a C1q Inhibitor, in Patients With Guillain-Barré Syndrome.
Mohammad QD, Islam Z, Papri N, Hayat S, et al · · 2025 · cited 10× · PMID 40000167 · DOI 10.1111/jns.70009
Repurposing MS immunotherapies for CIDP and other autoimmune neuropathies: unfulfilled promise or efficient strategy?
Kohle F, Dalakas MC, Lehmann HC. · · 2023 · cited 8× · PMID 36620728 · DOI 10.1177/17562864221137129

Verify or expand the search:

Other trials of ANX005

Trials testing the same drug.

NCT04691570 — Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANX005 in Participants With Warm Autoimmune Hemolytic Ane · Phase 2 · completed
NCT04569435 — Study of ANX005 in Adults With Amyotrophic Lateral Sclerosis (ALS) · Phase 2 · completed
NCT04514367 — An Open Label Study of ANX005 in Subjects With, or at Risk for, Manifest Huntington's Disease · Phase 2 · completed
NCT04035135 — A Clinical Study of ANX005 and IVIG in Subjects With Guillain Barré Syndrome (GBS) · Phase 1 · completed

Other recruiting trials for Guillain-Barre Syndrome

Currently open trials in the same condition.

NCT07020819 — An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barr · Phase 3 · recruiting

Other Annexon, Inc. trials

Trials by the same sponsor.

NCT07020819 — An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barr · Phase 3 · recruiting
NCT06510816 — A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of Vonaprument (Formerly ANX007) in Parti · Phase 3 · active not recruiting
NCT05780515 — A Study of ANX009 in Adult Participants With Lupus Nephritis · Phase 1 · completed
NCT05521269 — Dose Study of ANX1502 in Healthy Volunteers · Phase 1 · completed
NCT05288881 — Single Ascending Dose Study of ANX105 · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04701164 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Annexon, Inc.
Last refreshed: 29 May 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04701164.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing