Myositis

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)
  • PHENIX: Hizentra® in inflammatory neuropathy. pHeNIx study
  • 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-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
  • ARGX-117-2003 (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 (ARDA+)
  • 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
  • EFC17236-Sanofi Mobilize: A Phase 3, double-blind, placebo-controlled study evaluating efficacy and safety of riliprubart in participants with refractory chronic inflammatory demyelinating polyneuropathy

 

Acronym

ADSVF-in-IBM

IgPro20_3007

PHENIX
Pathology IBM DM Inflammatory neuropathies
Intervention Cell therapy IgPro20 Hizentra
Principal investigator Olivier Benveniste Olivier Benveniste C. Benoist
Sponsor APHP (PHCR) CSL Behring CSL Behring
Study status Active Active Active
Recruitment status Ongoing Ongoing Ongoing
Population Adult Adult Adult
+ infos on clinicaltrials.gov + infos on clinicaltrials.gov

 

Acronym

ARGX-113-1802 – ADHERE

ARGX-113-1902 – ADHERE +

ARGX-113-2007-ALKIVIA

ARGX-113-2011 (ALKIVIA+)
Pathology CIDP CIDP IIM IIM
Intervention efgartigimod efgartigimod efgartigimod
Principal investigator R. Debs R. Debs O. Benveniste
Sponsor Argenx Argenx Argenx Argenx
Study status Active Active In activation Active
Recruitment status Ongoing Ongoing Beginning soon Ongoing
Population Adult Adult Adult Adult
+ infos sur clinicaltrials.gov + infos sur clinicaltrials.gov + infos on clinicaltrials.gov + infos on clinicaltrials.gov

 

Acronym

ARGX-117-2003 (ARDA +)

GLPG3667-CL-214 (GALARISSO)

ABC008-IBM-201 (ABCURO)

EFC17236-Sanofi Mobilize
Pathology NMB  Dermatomyosite Myosite à inclusions Polyneuropathie inflammatoire démyélinisante chronique réfractaire
Intervention ARGX117 GLPG3667 ABC008 Riliprubart
Principal investigator K. Viala O. Benveniste O. Benveniste K. Viala
Sponsor Argenx Galapagos Abcuro SANOFI
Study status Active Active Active Active
Recruitment status Closed Ongoing Closed Ongoing
Population Adult Adult Adult Adult
+ infos on clinical trials.gov + infos on clinical trials.gov + infos on clinical trials.gov + infos on clinical trials.gov

 

Contact: essais-adultes@institut-myologie.org