Ongoing trials - Institut Myologie

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

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

MOM-M281-011

A phase 3, randomised, double-blind, placebo-controlled, multicentre study to evaluate the efficacy, safety, pharmacodynamics and pharmacokinetics of nipocalimab.

Code: MOM-M281-011
Disease: Autoimmune myasthenia gravis
Principal investigator: Sophie Demeret
Sponsor: Jannsen-Cilag
Status: Ongoing
Public: Adults
Phase: Phase 3
Trial site: I-Motion Adults

View on ClinicalTrials.gov

ASPIRO

A phase 1/2, randomised, controlled, open-label, ascending-dose clinical study to evaluate the safety and preliminary efficacy of AT132, a gene therapy delivered by an adeno-associated virus serotype 8 (AAV8) vector, in patients with X-linked myotubular myopathy (XLMTM).

Code: ASPIRO
Disease: Myotubular myopathy and other centronuclear myopathies
Principal investigator: Andreea Seferian
Sponsor: Audentes Therapeutics
Status: Active
Public: Paediatric
Phase: Phase 1
Trial site: I-Motion Pediatric

View on ClinicalTrials.gov

MYAPATH

Creation of a biological resource collection for the study of conditions that can lead to autoimmune myasthenia gravis.

Code: MYAPATH
Disease: Autoimmune myasthenia gravis
Principal investigator: Anthony Behin
Sponsor: AIM
Status: Ongoing
Public: Adults

NatHis-CNM

A prospective, longitudinal study assessing the natural history and motor function of patients with myotubular myopathy and other centronuclear myopathies.

Code: NatHis-CNM
Disease: Myotubular myopathy and other centronuclear myopathies
Principal investigator: Andreea Seferian
Sponsor: AIM
Status: Completed
Public: Adults, Paediatric

View on ClinicalTrials.gov

MS700568_0183

A phase 3, randomised, double-blind, placebo-controlled, three-arm, three-period study to evaluate the efficacy and safety of a new oral cladribine formulation.

Code: MS700568_0183
Disease: Autoimmune myasthenia gravis
Principal investigator: Anthony Behin
Sponsor: Merck
Status: In preparation
Public: Adults
Phase: Phase 3
Trial site: I-Motion Adults

View on ClinicalTrials.gov

NH-CNM-001

A prospective, longitudinal study of the natural history and functional status of patients with centronuclear myopathies.

Code: NH-CNM-001
Disease: Myotubular myopathy and other centronuclear myopathies
Principal investigator: Anthony Behin
Status: In preparation
Public: Adults
Trial site: I-Motion Adults

LOU064O12301

A phase 3, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of a Bruton tyrosine kinase inhibitor in patients with generalised myasthenia gravis.

Code: LOU064O12301
Disease: Autoimmune myasthenia gravis
Principal investigator: Anthony Behin
Sponsor: Novartis
Status: In preparation
Public: Adults
Phase: Phase 3
Trial site: I-Motion Adults

View on ClinicalTrials.gov