Trial intelligence / Profile preview

Nipocalimab versus efgartigimod in generalized myasthenia gravis, including switching from efgartigimod to nipocalimab

2025-521130-28-00Phase 3Authorised

Sponsor
Janssen Pharmaceutical
Start
Sep 2026
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes, Antibody Fragments → Engineered Antibody Formats → Antibody-Based Therapeutics
Countries
7
01

Overview

Phase 3, randomised, open-label trial in myasthenia gravis (MG) comparing Nipocalimab comparator arm, Efgartigimod alfa comparator arm and Switch from efgartigimod to nipocalimab (3 arms). Primary endpoints: Averaged mean change from baseline in MG-ADL total score over Weeks 8 to 12 between Arms 1 and 2 and Averaged mean percent change from baseline in total IgG over Weeks 8 to 12 between Arms 1 and 2. Planned start Sep 2026; status: authorised.

02

Drugs

nipocalimabefgartigimod alfa
03

Conditions

myasthenia gravis (MG)

Beyond the preview

Go deeper on 2025-521130-28-00.

Study design, results and competitive context are available in the Gosset platform where reported.

Study design & results

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on 2025-521130-28-00.

Gosset Free

Get started with Gosset.

Enter your corporate email.

Work email preferred.

Book a call