empasiprubart (ARGX-117) / argenx, Broteio - LARVOL DELTA

emvigorate: A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP (clinicaltrials.gov) - P3 | N=218 | Not yet recruiting | Sponsor: argenx

New P3 trial • Pain

Safety, tolerability, and efficacy of empasiprubart in adults with dermatomyositis (EMPACIFIC): A phase 2, randomized, double-blind, placebo-controlled, multicenter study (EULAR 2025) - No abstract available

Clinical • P2 data • Dermatomyositis • Immunology • Myositis

Empassion: A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults with Multifocal Motor Neuropathy (clinicaltrials.gov) - P3 | N=100 | Recruiting | Sponsor: argenx | Not yet recruiting ➔ Recruiting

Enrollment open • Complement-mediated Rare Disorders • Pain

Empassion: A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults with Multifocal Motor Neuropathy (clinicaltrials.gov) - P3 | N=100 | Not yet recruiting | Sponsor: argenx

New P3 trial • Complement-mediated Rare Disorders • Pain

ARDA+: A Clinical Trial to Investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults with Multifocal Motor Neuropathy (clinicaltrials.gov) - P2 | N=51 | Active, not recruiting | Sponsor: argenx | Enrolling by invitation ➔ Active, not recruiting | Trial primary completion date: Nov 2025 ➔ Sep 2026

Enrollment closed • Trial primary completion date • Complement-mediated Rare Disorders • Pain

ARDA: A Clinical Trial to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults with Multifocal Motor Neuropathy (clinicaltrials.gov) - P2 | N=54 | Completed | Sponsor: argenx | Active, not recruiting ➔ Completed | Trial completion date: Oct 2024 ➔ Jun 2024 | Trial primary completion date: Oct 2024 ➔ Jun 2024

Trial completion • Trial completion date • Trial primary completion date • Complement-mediated Rare Disorders • Pain

empacific: A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults with Dermatomyositis (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: argenx | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatomyositis • Immunology • Myositis

argenx Reports Half Year 2024 Financial Results and Provides Second Quarter Business Update (GlobeNewswire) - "Generated global net product sales (inclusive of both VYVGART and VYVGART SC) of $478 million in second quarter of 2024...Phase 3 study of empasiprubart for MMN to initiate in fourth quarter of 2024...Phase 1b/2a studies of ARGX-119 to assess early signal detection in patients with CMS and ALS to start by end of 2024."

New P1/2 trial • New P3 trial • Sales • Amyotrophic Lateral Sclerosis • CNS Disorders • Immunology • Myasthenia Gravis

empacific: A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis (clinicaltrials.gov) - P2 | N=42 | Not yet recruiting | Sponsor: argenx | N=80 ➔ 42

Enrollment change • Dermatomyositis • Immunology • Myositis

ARDA+: A Clinical Trial to Investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy (clinicaltrials.gov) - P2 | N=48 | Enrolling by invitation | Sponsor: argenx | Recruiting ➔ Enrolling by invitation

Enrollment status • Complement-mediated Rare Disorders • Pain

Empasiprubart (ARGX-117) in Multifocal Motor Neuropathy: Initial Safety and Efficacy data of the Phase 2 ARDA Study (EAN 2024) - P2 | "Early efficacy and safety signals in cohort 1 from the ongoing ARDA study support proof of concept of empasiprubart in MMN."

Clinical • P2 data • Complement-mediated Rare Disorders • Pain

argenx to unveil its ‘Vision 2030: Taking Breakthrough Science to 50,000 Patients’ during its Upcoming R&D Day on July 16, 2024 (GlobeNewswire) - "argenx SE...today announced that it will host an R&D day on Tuesday, July 16, 2024 at 8:30am ET in New York City to unveil its ‘Vision 2030: Taking Breakthrough Science to 50,000 Patients’ and provide updates from across its current and future clinical pipeline....The R&D Day agenda will include the following topics...Topline Phase 2 RHO data in Sjogren’s disease; Preview of Phase 2/3 ALKIVIA study in immune-mediated myopathies; Expansion of MG opportunity through label-enabling studies, including seronegative MG...Next pipeline-in-a-product opportunity with empasiprubart; Phase 2 ARDA data in multifocal motor neuropathy (MMN); Preview of Phase 2 studies in delayed graft function and dermatomyositis; Introduction of fourth indication..."

New indication • P2 data • P2/3 data • Dermatomyositis • Immunology • Myasthenia Gravis • Myositis • Sjogren's Syndrome

ARGX-117-2301: A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: argenx | Initiation date: May 2024 ➔ Sep 2024

Trial initiation date • Dermatomyositis • Immunology • Myositis

VARVARA: ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function (clinicaltrials.gov) - P2 | N=102 | Recruiting | Sponsor: argenx | Not yet recruiting ➔ Recruiting

Enrollment open • Transplantation

A Study of Empasiprubart's Effect on the Body, Levels in the Blood, Effectiveness, and Safety in Adults With Dermatomyositis (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: argenx

New P2 trial • Dermatomyositis • Immunology • Myositis

ARDA: A Clinical Trial to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy (clinicaltrials.gov) - P2 | N=54 | Active, not recruiting | Sponsor: argenx | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2024 ➔ Oct 2024 | Trial primary completion date: Feb 2024 ➔ Oct 2024

Enrollment closed • Trial completion date • Trial primary completion date • Complement-mediated Rare Disorders • Pain

VARVARA: ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function (clinicaltrials.gov) - P2 | N=102 | Not yet recruiting | Sponsor: argenx | Initiation date: Oct 2023 ➔ Feb 2024

Trial initiation date • Transplantation

ARDA: A Clinical Trial to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy (clinicaltrials.gov) - P2 | N=48 | Recruiting | Sponsor: argenx | Trial primary completion date: May 2023 ➔ Feb 2024

Trial primary completion date • Complement-mediated Rare Disorders • Pain

VARVARA: ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function (clinicaltrials.gov) - P2 | N=102 | Not yet recruiting | Sponsor: argenx

New P2 trial • Transplantation

ARDA+: A Clinical Trial to Investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy (clinicaltrials.gov) - P2 | N=48 | Recruiting | Sponsor: argenx | Not yet recruiting ➔ Recruiting | Initiation date: Oct 2022 ➔ Jan 2023

Enrollment open • Trial initiation date • Complement-mediated Rare Disorders • Pain

Complement inhibition prevents glial nodal membrane injury in a GM1 antibody-mediated mouse model. (PubMed, Brain Commun) - "These data demonstrate that complement inhibition prevents injury in a Schwann cell nodal membrane injury model, which is representative of neuropathies associated with anti-GM1 antibodies, including Guillain-Barré syndrome and multifocal motor neuropathy. This outcome suggests that both the motor axonal and demyelinating variants of Guillain-Barré syndrome should be included in future complement inhibition clinical trials."

Journal • Preclinical • Complement-mediated Rare Disorders • Pain

A clinical trial to investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy Ensayo clínico para investigar a largo plazo la seguridad, tolerabilidad, eficacia, farmacodinámica, farmacocinética y la inmunogenicidad de ARGX-117 en adultos con neuropatía motora multif (clinicaltrialsregister.eu) - P2 | N=48 | Ongoing | Sponsor: argenx BV

New P2 trial • Complement-mediated Rare Disorders • Pain

SAD and MAD Study With IV and SC Doses of ARGX-117 (clinicaltrials.gov) - P1 | N=110 | Completed | Sponsor: argenx | Active, not recruiting ➔ Completed

Trial completion

ARDA+: A Clinical Trial to Investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy (clinicaltrials.gov) - P2 | N=48 | Not yet recruiting | Sponsor: argenx

New P2 trial • Complement-mediated Rare Disorders • Pain

SAD and MAD Study With IV and SC Doses of ARGX-117 (clinicaltrials.gov) - P1 | N=110 | Active, not recruiting | Sponsor: argenx | Recruiting ➔ Active, not recruiting

Enrollment closed