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)
- 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-113-2011 (ALKIVIA+): A Phase 3, Single-Arm, Multicenter, Open-label Extension of Study ARGX-113-2007 to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy
- GLPG3667-CL-214 (GALARISSO): A randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered GLPG3667 once daily for 24 weeks in adult subjects with dermatomyositis
- ABC008-IBM-201 (ABCURO): A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis
Acronym |
ADSVF-in-IBM |
IgPro20_3007 |
| Pathology | IBM | DM |
| Intervention | Cell therapy | IgPro20 |
| Principal investigator | Olivier Benveniste | Olivier Benveniste |
| Sponsor | APHP (PHCR) | CSL Behring |
| Study status | Active | Active |
| Recruitment status | Ongoing | Ongoing |
| Population | Adult | Adult |
| + infos on clinicaltrials.gov | + infos on clinicaltrials.gov |
Acronym |
ARGX-113-2007-ALKIVIA |
ARGX-113-2011 (ALKIVIA+) |
| Pathology | IIM | IIM |
| Intervention | efgartigimod | |
| Principal investigator | O. Benveniste | |
| Sponsor | Argenx | Argenx |
| Study status | In activation | Active |
| Recruitment status | Beginning soon | Ongoing |
| Population | Adult | Adult |
| + infos on clinicaltrials.gov | + infos on clinicaltrials.gov |
Acronym |
GLPG3667-CL-214 (GALARISSO) |
ABC008-IBM-201 (ABCURO) |
| Pathology | Dermatomyosite | Myosite à inclusions |
| Intervention | GLPG3667 | ABC008 |
| Principal investigator | O. Benveniste | O. Benveniste |
| Sponsor | Galapagos | Abcuro |
| Study status | Active | Active |
| Recruitment status | Ongoing | Closed |
| Population | Adult | Adult |
| + infos on clinical trials.gov | + infos on clinical trials.gov |
Contact: essais-adultes@institut-myologie.org
