Ongoing trials - Institut Myologie

ARGX-113-2011 – ALKIVIA+

A phase 3, multicentre, open-label extension study of the long-term safety, tolerability and efficacy of efgartigimod PH20 SC.

Code: ARGX-113-2011
Disease: Myositis
Principal investigator: O. Benveniste
Sponsor: Argenx
Status: Active
Public: Adults
Phase: Phase 3
Trial site: I-Motion Adults

View on ClinicalTrials.gov

GLPG3667-CL-214 – GALARISSO

A multicentre, randomised, double-blind, placebo-controlled study evaluating the efficacy and safety of oral GLPG3667 over 24 weeks in adults with dermatomyositis.

Code: GLPG3667-CL-214
Disease: Myositis
Principal investigator: O. Benveniste
Sponsor: Galapagos
Status: Active
Public: Adults
Trial site: I-Motion Adults

View on ClinicalTrials.gov

ABC008-IBM-201 – ABCURO

A phase 2/3, randomised, double-blind, placebo-controlled, multicentre study evaluating the efficacy and safety of ABC008 in patients with inclusion body myositis.

Code: ABC008-IBM-201
Disease: Myositis
Principal investigator: O. Benveniste
Sponsor: Abcuro
Status: Active
Public: Adults
Phase: Phase 2
Trial site: I-Motion Adults

View on ClinicalTrials.gov

LUPIN-PASS – Namuscla observational study

An observational study to describe the long-term safety and efficacy of Namuscla in the symptomatic management of myotonia in adult patients with non-dystrophic myotonic disorders.

Code: LUPIN-PASS
Disease: Non-dystrophic myotonias
Principal investigator: S. Vicart
Sponsor: Lupin
Status: Active
Public: Adults
Trial site: I-Motion Adults

ARGX-117-2003 (ARDA Ext)

A long-term extension of trial ARGX-117-2002: assessment of the long-term safety, tolerability, efficacy, pharmacodynamics, pharmacokinetics and immunogenicity of ARGX-117.

Code: ARGX-117-2003
Disease: Multifocal motor neuropathy
Principal investigator: K. Viala
Sponsor: Argenx
Status: Active
Public: Adults
Trial site: I-Motion Adults

View on ClinicalTrials.gov

ARGX-113-1802 – ADHERE

A phase 2 trial to investigate the efficacy, safety and tolerability of efgartigimod PH20 SC in adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

Code: ARGX-113-1802
Disease: Chronic inflammatory demyelinating polyneuropathy
Principal investigator: R. Debs
Sponsor: Argenx
Status: Active
Public: Adults
Phase: Phase 2
Trial site: I-Motion Adults

View on ClinicalTrials.gov

ARGX-113-1902 – ADHERE +

An open-label extension of study ARGX-113-1802 to investigate the long-term safety, tolerability and efficacy of efgartigimod PH20 SC in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

Code: ARGX-113-1902
Disease: Chronic inflammatory demyelinating polyneuropathy
Principal investigator: R. Debs
Sponsor: Argenx
Status: Active
Public: Adults
Trial site: I-Motion Adults

View on ClinicalTrials.gov

EFC17236-Sanofi Mobilize

A phase 3, double-blind, placebo-controlled study evaluating the efficacy and safety of riliprubart in participants with refractory chronic inflammatory demyelinating polyneuropathy.

Code: EFC17236-Sanofi-Mobilize
Disease: Chronic inflammatory demyelinating polyneuropathy
Principal investigator: K. Viala
Sponsor: SANOFI
Status: Active
Public: Adults
Phase: Phase 3
Trial site: I-Motion Adults

View on ClinicalTrials.gov

pHeNIx

Hizentra in inflammatory neuropathies.

Code: pHeNIx
Disease: Chronic inflammatory demyelinating polyneuropathy
Principal investigator: C. Benoist
Sponsor: CSL Behring
Status: Active
Public: Adults
Trial site: I-Motion Adults

View on ClinicalTrials.gov

ARISE-JANSSEN

A phase 2/3, multicentre, multi-stage, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of nipocalimab in adults with chronic inflammatory demyelinating polyneuropathy (CIDP).

Code: ARISE-JANSSEN
Disease: Chronic inflammatory demyelinating polyneuropathy
Principal investigator: K. Viala
Sponsor: JANSSEN
Status: In preparation
Public: Adults
Phase: Phase 2
Trial site: I-Motion Adults

View on ClinicalTrials.gov

STRONG

Measurement of GDF5 protein expression in muscle biopsies and serum from healthy participants.

Code: STRONG
Disease: Sarcopenia
Principal investigator: France Pietri-Rouxel
Sponsor: AIM
Status: Active
Public: Adults
Trial site: I-Motion Adults

ARGX-119-2302

A phase 1b, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and efficacy of ARGX-119 in adult participants with congenital myasthenic syndromes related to DOK7 gene mutations.

Code: ARGX-119-2302
Disease: Congenital myasthenic syndromes
Principal investigator: Villars
Sponsor: Argenx
Status: Active
Public: Adults
Phase: Phase 1
Trial site: I-Motion Adults

View on ClinicalTrials.gov

ARGX-113-2007 ALKIVIA

A phase 2/3, randomised, double-blind, placebo-controlled study evaluating the efficacy and safety of efgartigimod PH20 SC in patients with active idiopathic inflammatory myopathy.

Code: ARGX-113-2007-ALKIVIA
Disease: Myositis
Principal investigator: O. Benveniste
Sponsor: Argenx
Status: Active
Public: Adults
Phase: Phase 2
Trial site: I-Motion Adults

View on ClinicalTrials.gov

DT4RD

Feasibility, validation and application of digital tools for the follow-up of patients with neuromuscular diseases in daily life.

Code: DT4RD
Disease: Cross-disease studies
Principal investigator: Marion Masingue
Sponsor: AIM
Status: Active
Public: Adults
Trial site: I-Motion Adults

Resolve France Expansion – CTRN FSHD France

An 18-month prospective MRI study in facioscapulohumeral muscular dystrophy.

Code: Resolve-France-Expansion
Disease: Facioscapulohumeral muscular dystrophy
Principal investigator: Teresinha Evangelista
Sponsor: CHU de Nice
Status: Active
Public: Adults
Trial site: I-Motion Adults

View on ClinicalTrials.gov

ARGX113-2308 ADAPT (Seroneg)

A phase 3, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of intravenous efgartigimod in adult patients with seronegative generalised myasthenia gravis.

Code: ARGX113-2308
Disease: Autoimmune myasthenia gravis
Principal investigator: Sophie Demeret
Sponsor: Argenx
Status: Active
Public: Adults
Phase: Phase 3
Trial site: I-Motion Adults

View on ClinicalTrials.gov

PROGRESS FSHD

Remote assessment and artificial intelligence to validate new measures, biomarkers and new therapeutic targets in facioscapulohumeral muscular dystrophy.

Code: PROGRESS-FSHD
Disease: Facioscapulohumeral muscular dystrophy
Principal investigator: Teresinha Evangelista
Sponsor: CHU de Nice
Status: Active
Public: Adults
Trial site: I-Motion Adults

View on ClinicalTrials.gov

ARGX-113-2003 – ADAPT NXT

A phase 3b, randomised, open-label, parallel-group study to evaluate different dosing regimens of intravenous efgartigimod in patients with generalised myasthenia gravis.

Code: ARGX-113-2003 – ADAPT NXT
Disease: Autoimmune myasthenia gravis
Principal investigator: Sophie Demeret
Sponsor: Argenx
Status: Active
Public: Adults
Phase: Phase 3
Trial site: I-Motion Adults

View on ClinicalTrials.gov

ReSOLVE FSHD International

Clinical trial readiness to solve barriers to drug development in FSHD.

Code: ReSOLVE-FSHD-International
Disease: Facioscapulohumeral muscular dystrophy
Principal investigator: Guillaume Bassez
Sponsor: CHU de Nice
Status: Active
Public: Adults
Trial site: I-Motion Adults

R3918-MG-2018

Efficacy and safety of pozelimab and cemdisiran combination therapy in patients with autoimmune myasthenia gravis.

Code: R3918-MG-2018
Disease: Autoimmune myasthenia gravis
Principal investigator: Sophie Demeret
Sponsor: Regeneron
Status: Ongoing
Public: Adults
Trial site: I-Motion Adults

View on ClinicalTrials.gov