NCT05827874 is a Phase 1 clinical trial of Nipocalimab in Healthy, sponsored by Janssen Research & Development, LLC.

Who is sponsoring NCT05827874?

NCT05827874 is sponsored by Janssen Research & Development, LLC.

What drugs are being tested in NCT05827874?

Interventions in NCT05827874: Nipocalimab, Tdap, PPSV23.

Is NCT05827874 still recruiting?

NCT05827874 is currently completed. Last updated 4 March 2025.

Last reviewed 2025-03-04 · How we verify

NCT05827874

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

A Study on the Effect of Nipocalimab on Vaccine Responses in Healthy Participants

Completed Phase 1 Last updated 4 March 2025

What this trial tests

Phase 1 trial testing Nipocalimab in Healthy in 32 participants. Completed in 4 October 2023.

Timeline

12 April 2023

Primary endpoint
4 October 2023

4 October 2023

Quick facts

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	32
Start date	12 April 2023
Primary completion	4 October 2023
Estimated completion	4 October 2023
Sites	1 location across Germany

Drugs / interventions tested

Nipocalimab (NIPOCALIMAB) — full drug profile →
Tdap — full drug profile →
PPSV23 (ppsv23) — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

Adults 18 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to assess the effect of nipocalimab treatment on the antibody (a protein made in the body to response to a foreign substance) response following tetanus, diphtheria, pertussis (Tdap) vaccination in healthy participants at Week 4.

Publications & conference data

2 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
A randomized, open-label study on the effect of nipocalimab on vaccine responses in healthy participants.
Cossu M, Bobadilla Mendez C, Jackson A, Myshkin E, et al · · 2025 · cited 4× · PMID 40232701 · DOI 10.1080/21645515.2025.2491269

Verify or expand the search:

Other trials of Nipocalimab

Trials testing the same drug.

NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
NCT04883619 — A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis · Phase 2 · withdrawn
NCT07217587 — Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis · Phase 3 · recruiting
NCT06533098 — A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thro · Phase 3 · recruiting
NCT06741969 — Nipocalimab in Moderate to Severe Sjogren's Disease · Phase 3 · active not recruiting

Other recruiting trials for Healthy

Currently open trials in the same condition.

NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting

Other Janssen Research & Development, LLC trials

Trials by the same sponsor.

NCT07518186 — A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma · Phase 3 · not yet recruiting
NCT07309445 — A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC · recruiting
NCT07499232 — A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease · Phase 3 · not yet recruiting
NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
NCT07227025 — A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer · Phase 1, PHASE2 · 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 NCT05827874 (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 Janssen Research & Development, LLC
Last refreshed: 4 March 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/NCT05827874.

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