Myositis (Idiopathic Inflammatory Myopathy, IIM) are auto-immune diseases related to muscles. They are not hereditary. They are characterized by a muscle weakness and fatigability, and very often by muscle pain (myalgia).
Clinical trials ongoing at the Institute:
- ADSVF-in-IBM: Cell therapy for Inclusion Body Myositis (IBM) by muscle injection of autologous uncultured Adipose-Derived Stromal Vascular Fraction (ADSVF): a phase I trial
- IgPro20_3007: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM)
- SPIREA 80202135IIM2001: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Nipocalimab in Participants with Active Idiopathic Inflammatory Myopathies
- ARGX-113-1802 – ADHERE: A Phase 2a/2b, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Patients With Active Idiopathic Inflammatory Myopathy (IIM).
- ARGX-113-1902 – ADHERE +: Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
- ARGX-113-2007-ALKIVIA: A Phase 2a/2b, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Patients With Active Idiopathic Inflammatory Myopathy (IIM).
- ARGX-117-2002_ARDA: A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy
- ARGX-117-2003 (ARDA Ext): 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 (ARDA+)
Acronym |
ADSVF-in-IBM |
IgPro20_3007 |
SPIREA 80202135IIM2001 |
| Intervention | Cell therapy | IgPro20 | nipocalimab |
| Principal investigator | Olivier Benveniste | Olivier Benveniste | Olivier Benveniste |
| Sponsor | APHP (PHCR) | CSL Behring | Jannsen-Cilag |
| Pathology | IBM | DM | IIM |
| Study status | Active | Active | In activation |
| Recruitment status | Ongoing | Ongoing | Beginning soon |
| Population | Adult | Adult | Adult |
| + infos on clinicaltrials.gov | + infos on clinicaltrials.gov | + infos on clinicaltrials.gov |
Acronym |
ARGX-113-1802 – ADHERE |
ARGX-113-1902 – ADHERE + |
ARGX-113-2007-ALKIVIA |
ARGX-117-2002_ARDA |
ARGX-117-2003 (ARDA Ext) |
| Intervention | efgartigimod | efgartigimod | efgartigimod | ARGX117 | ARGX117 |
| Principal investigator | R. Debs | R. Debs | O. Benveniste | K. Viala | K. Viala |
| Sponsor | Argenx | Argenx | Argenx | Argenx | Argenx |
| Pathology | CIDP | CIDP | IIM | NMB | NMB |
| Study status | Active | Active | In activation | Active | Active |
| Recruitment status | Ongoing | Ongoing | Beginning soon | Ongoing | Beginning soon |
| Population | Adult | Adult | Adult | Adult | Adult |
| + infos sur clinicaltrials.gov | + infos sur clinicaltrials.gov | + infos on clinicaltrials.gov | + infos on clinicaltrials.gov | + infos on clinicaltrials.gov |
Contact: essais-adultes@institut-myologie.org
