Empasiprubart IV

BIOLOGICAL9 trials

Sponsors

argenx

Conditions

AChR-Ab Seropositive Generalized Myasthenia GravisCIDPCIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)Chronic Inflammatory Demyelinating PolyneuropathyChronic Inflammatory Demyelinating PolyradiculoneuropathyChronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)DermatomyositisGeneralized Myasthenia Gravis

Phase 1

A Study to Assess the Absolute Bioavailability of Empasiprubart SC Administered With an Autoinjector and the Pharmacokinetic Noninferiority of Empasiprubart SC Versus Intravenous (IV) in Healthy Adult Participants

RecruitingNCT07612020

argenxHealthy Volunteers

Start: 2026-03-16End: 2027-10-01Target: 130Updated: 2026-05-28

A Study to Assess the Effect of Empasiprubart on Nerve Morphology by Ultrasound in Adults With Multifocal Motor Neuropathy

RecruitingNCT07610564

argenxMultifocal Motor Neuropathy (MMN)

Start: 2026-07-27End: 2030-04-01Target: 60Updated: 2026-08-13

Phase 2

A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis

Active, not recruitingNCT06284954

argenxDermatomyositis, Myositis

Start: 2024-08-20End: 2026-11-30Updated: 2025-09-25

ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod

RecruitingNCT07284420

argenxAChR-Ab Seropositive Generalized Myasthenia Gravis, Generalized Myasthenia Gravis, Generalized Myasthenia Gravis (gMG) +3

Start: 2025-12-19End: 2028-03-07Target: 70Updated: 2026-09-18

A Study to Assess the Correct Dose, Safety and Efficacy of Empasiprubart in Adolescent Participants Aged 12 to Less Than 18 Years With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Not yet recruitingNCT07638566

argenxChronic Inflammatory Demyelinating Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), CIDP +1

Start: 2026-09-01End: 2031-08-01Target: 6Updated: 2026-06-10

ADAPT Forward 2 - ISA2 - a Study to Evaluate the Safety, Tolerability and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis

RecruitingNCT07673627

argenxAChR-Ab Seropositive Generalized Myasthenia Gravis, gMG, MG - Myasthenia Gravis +1

Start: 2026-07-10End: 2028-04-01Target: 40Updated: 2026-09-18

A Study of Empasiprubart as Add-On Therapy to IVIg in Adult Participants With Guillain-Barré Syndrome

Not yet recruitingNCT07821762

argenxGuillain-Barré Syndrome (GBS)

Start: 2026-12-01End: 2029-03-01Target: 63Updated: 2026-09-16

Phase 3

A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP

RecruitingNCT07091630

argenxChronic Inflammatory Demyelinating Polyneuropathy, Chronic Inflammatory Demyelinating Polyradiculoneuropathy, CIDP

Start: 2025-09-16End: 2031-01-23Target: 160Updated: 2026-09-17

Unknown Phase

ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis

RecruitingNCT07294170

argenxAChR-Ab Seropositive Generalized Myasthenia Gravis, Generalized Myasthenia Gravis, Generalized Myasthenia Gravis (gMG) +3

Start: 2025-12-19End: 2028-03-07Target: 70Updated: 2026-09-18