NCT05163834 is a Phase 1 clinical trial of Efgartigimod in Healthy Volunteers, sponsored by argenx.

Who is sponsoring NCT05163834?

NCT05163834 is sponsored by argenx.

What drugs are being tested in NCT05163834?

Interventions in NCT05163834: Efgartigimod, Placebo, PNEUMOVAX 23.

What condition does NCT05163834 study?

NCT05163834 studies Healthy Volunteers.

Is NCT05163834 still recruiting?

NCT05163834 is currently completed. Last updated 17 March 2022.

Last reviewed 2022-03-17 · How we verify

NCT05163834

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

Immune Response to PNEUMOVAX 23 in Healthy Adults Receiving Efgartigimod IV

Completed Phase 1 Last updated 17 March 2022

What this trial tests

Phase 1 trial testing Efgartigimod in Healthy Volunteers in 36 participants. Completed in 8 March 2022.

Timeline

17 November 2021

Primary endpoint
8 March 2022

8 March 2022

Quick facts

Lead sponsor	argenx
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	36
Start date	17 November 2021
Primary completion	8 March 2022
Estimated completion	8 March 2022
Sites	1 location across Netherlands

Drugs / interventions tested

Efgartigimod — full drug profile →
Placebo
PNEUMOVAX 23 — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

argenx — full company profile →

Who can join

18 and older, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomized, open-label, placebo-controlled phase 1 study in healthy adult volunteers to provide information regarding vaccination with a common pneumococcal polysaccharide vaccine while receiving efgartigimod.

Publications & conference data

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

Targeting the Neonatal Fc Receptor in Autoimmune Diseases: Pipeline and Progress.
Gjølberg TT, Mester S, Calamera G, Telstad JS, et al · · 2025 · cited 10× · PMID 40156757 · DOI 10.1007/s40259-025-00708-2
Impact of FcRn antagonism on vaccine-induced protective immune responses against viral challenge in COVID-19 and influenza mouse vaccination models.
Warang P, Singh G, Moshir M, Binazon O, et al · · 2025 · cited 7× · PMID 40028815 · DOI 10.1080/21645515.2025.2470542
Humoral immune response to polyvalent pneumococcal vaccine in healthy participants receiving efgartigimod: a randomized, open-label, placebo-controlled, parallel-group phase 1 trial.
Azar AE, Sleasman JW, Steeland S, Verhamme FM, et al · · 2026 · PMID 42183242 · DOI 10.3389/fimmu.2026.1799480

Verify or expand the search:

Other trials of Efgartigimod

Trials testing the same drug.

NCT07217587 — Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis · Phase 3 · recruiting
NCT07025330 — A Study of Efgartigimod in Patients With IgG4-Related Disease · Phase 2 · recruiting
NCT07072988 — Evaluate the Benefit of Corticoid Sparing in Elderly With Generalized AntiRAch Myasthenia Gravis Treated With IV or SC E · Phase 4 · recruiting
NCT06528392 — Efgartigimod for Stiff Person Syndrome (ESPS) · Phase 2 · not yet recruiting
NCT06860633 — Treatment of Myasthenia Gravis Exacerbation or Crisis With Efgartigimod · Phase 4 · recruiting

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

NCT07504003 — Influence of Training Session Duration on Improvements in Physiological Resilience to Exercise · NA · recruiting
NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
NCT07495813 — A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease · Phase 1 · recruiting
NCT07499050 — A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity · Phase 1 · recruiting
NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting

Other argenx trials

Trials by the same sponsor.

NCT07377396 — A Study to Assess the Safety of ARGX-124 in Healthy Volunteers · Phase 1 · recruiting
NCT07287982 — A Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Intravenous Administration · Phase 2 · recruiting
NCT07284420 — ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With · Phase 2 · recruiting
NCT07294170 — ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Particip · recruiting
NCT07091630 — A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP · Phase 3 · recruiting

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 NCT05163834 (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 argenx
Last refreshed: 17 March 2022

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/NCT05163834.

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