Clinical trials: gMG
Myasthenia Gravis, MG
ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis
ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis.
- Conditions
- Myasthenia Gravis, MG, gMG, Generalized Myasthenia Gravis
- Trial name
- NCT07294170
- Testing
- Efgartigimod IV, Empasiprubart IV, Efgartigimod PH20 SC PFS
- Where
- 37 sites in United States, Belgium and 6 more
- Volunteers
- 70 people
- Sponsor
- argenx
Generalized Myasthenia Gravis, gMG
Efficacy and Safety of Ravulizumab in Chinese Adults Participants With Generalized Myasthenia Gravis (gMG)
The primary purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab in Chinese adult participants with Acetylcholine receptor (AChR) + Generalized…
- Trial name
- NCT07596784
- Testing
- Ravulizumab
- Where
- 10 sites in China
- Volunteers
- 20 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Generalized Myasthenia Gravis (gMG)
RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis
RESET-MG: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Participants with Generalized Myasthenia Gravis
- Trial name
- NCT06359041
- Testing
- CABA-201
- Where
- 17 sites in United States
- Volunteers
- 24 people
- Sponsor
- Cabaletta Bio
AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis (MG)
ADAPT Forward 2 - ISA2 - a Study to Evaluate the Safety, Tolerability and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis
This study is part of the ADAPT Forward platform study (NCT07294170). ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis.
- Conditions
- AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis (MG), MG - Myasthenia Gravis, gMG
- Trial name
- ADAPT Forward2 (NCT07673627)
- Testing
- Empasiprubart IV, Efgartigimod PH20 SC PFS
- Where
- 8 sites in United States, Greece and 1 more
- Volunteers
- 40 people
- Sponsor
- argenx
Rare Diseases, Generalized Myasthenia Gravis (gMG)
Epidemiological Study of Treatment Approaches in AChR-Antibody Positive Generalized Myasthenia Gravis in Russia
This is a multicenter, non-interventional, retrospective-prospective, single-arm observational study designed to describe real-world treatment approaches and clinical outcomes among adults with acetylcholine receptor (AChR)…
- Trial name
- NCT07247279
- Where
- 7 sites in Russia
- Volunteers
- 450 people
- Sponsor
- AstraZeneca
AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis
ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod
This study is part of the ADAPT Forward platform study (NCT07294170). ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis.
- Conditions
- AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis, MG, gMG
- Trial name
- NCT07284420
- Testing
- Efgartigimod IV, Empasiprubart IV
- Where
- 33 sites in United States, Belgium and 6 more
- Volunteers
- 70 people
- Sponsor
- argenx
Generalized Myasthenia Gravis (gMG)
An Open-label, Dose-escalation Phase Ib Study of EA5 Injection in Adults With Anti-AChR Antibody-Positive Generalized Myasthenia Gravis
This is a Phase Ib, open-label, dose-escalation, single-center/multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of multiple doses of EA5 (a humanized…
- Trial name
- NCT07818291
- Testing
- EA5
- Where
- 2 sites in China
- Volunteers
- 18 people
- Sponsor
- Shanghai Lanyi Therapeutics Co., Ltd.
Generalized Myasthenia Gravis, gMG
A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis
The primary purpose of this study is to measure the efficacy and safety of efgartigimod IV compared to placebo in participants with Acetylcholine Receptor Binding Antibody (AChR-Ab) seronegative Generalized Myasthenia Gravis…
- Conditions
- Generalized Myasthenia Gravis, gMG, Myasthenia Gravis, Generalized, Myasthenia Gravis
- Trial name
- ADAPT SERON (NCT06298552)
- Testing
- Efgartigimod IV
- Where
- 91 sites in United States, Belgium and 20 more
- Volunteers
- 119 people
- Sponsor
- argenx
Generalized Myasthenia Gravis, MG - Myasthenia Gravis
An Open-label Study to Investigate the Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV in Patients With Generalized Myasthenia Gravis
The purpose of this open-label study is to investigate the efficacy, safety, and tolerability of a continuous regimen of efgartigimod compared with a cyclic regimen in participants with Generalized Myasthenia Gravis (gMG).
- Conditions
- Generalized Myasthenia Gravis, MG - Myasthenia Gravis, gMG
- Trial name
- ADAPT NXT (NCT04980495)
- Testing
- Efgartigimod IV
- Where
- 39 sites in United States, Austria and 9 more
- Volunteers
- 69 people
- Sponsor
- argenx
Generalized Myasthenia Gravis (gMG), gMG
A Study to Evaluate the Impact of Efgartigimod on Overall Disease Experience of People Suffering From Generalized Myasthenia Gravis (gMG) in Italy
This study aims to generate real world evidence (RWE) from Italian clinical practice on the impact of efgartigimod alfa in gMG patients encompassing clinical outcomes and patient reported experiences.
- Trial name
- POEMA (NCT07595653)
- Where
- 30 sites in Italy
- Volunteers
- 100 people
- Sponsor
- argenx
Generalized Myasthenia Gravis, gMG
Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis
The purpose of this trial is to evaluate the long-term safety of efgartigimod IV and efgartigimod PH20 SC administered to participants with gMG in the antecedent studies, ARGX-113-2006 and ARGX-113-2207, respectively.
- Trial name
- ADAPT Jr + (NCT05374590)
- Testing
- Efgartigimod IV or Efgartigimod PH20 SC
- Where
- 16 sites in United States, Belgium and 8 more
- Volunteers
- 12 people
- Sponsor
- argenx
Generalized Myasthenia Gravis, gMG
Evaluation of PK, PD, Efficacy, Safety, and Immunogenicity of IV Ravulizumab in Pediatric Participants With Generalized Myasthenia Gravis
The primary purpose of this study is to characterize the pharmacokinetics and pharmacodynamics of treatment with ravulizumab intravenous infusion in pediatric participants with gMG.
- Trial name
- NCT05644561
- Testing
- Ravulizumab
- Where
- 11 sites in United States, Italy and 3 more
- Volunteers
- 12 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Ultomiris-exposed Pregnant/ Postpartum, Pregnancy
Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
The primary objective of this study is to describe the frequency and characteristics of pregnancy outcomes and maternal complications among participants exposed to Ultomiris and to describe the frequency and characteristics of…
- Conditions
- Ultomiris-exposed Pregnant/ Postpartum, Pregnancy, Paroxysmal Nocturnal Hemoglobinuria (PNH), Atypical Hemolytic Uremic Syndrome (aHUS)
- Trial name
- NCT06312644
- Testing
- Ultomiris
- Where
- 7 sites in United States, Australia and 5 more
- Volunteers
- 75 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Generalized Myasthenia Gravis, gMG
A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab
This is a prospective, multicenter single arm study designed to evaluate the effectiveness and safety of a predefined oral corticosteroids (OCS) tapering schedule to reduce OCS use in adult participants with acetylcholine…
- Trial name
- OCTAGON (NCT07221838)
- Testing
- Oral Corticosteroid Tapering Schedule, Ravulizumab, Prednisone/Prednisolone
- Where
- 12 sites in United States, Germany and 2 more
- Volunteers
- 75 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Generalized Myasthenia Gravis, gMG
PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia Gravis
The primary objective of this study is to assess the pharmacokinetics and pharmacodynamics of gefurulimab in pediatric participants with AChR+ gMG for the duration of the study.
- Trial name
- NCT06607627
- Testing
- Gefurulimab
- Where
- 13 sites in United States, Brazil and 3 more
- Volunteers
- 12 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
New Onset Generalized Myasthenia Gravis (gMG)
A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)
The main purpose of this study is to measure how well adults with new-onset gMG (which means they've had generalized disease signs and/or symptoms for less than 1 year) respond to treatment with efgartigimod PH20 SC.
- Trial name
- ADAPT-EARLY (NCT06909214)
- Testing
- Efgartigimod PH20 SC
- Where
- 18 sites in United States
- Volunteers
- 30 people
- Sponsor
- argenx
Generalized Myasthenia Gravis (gMG), Refractory gMG
Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Chinese Adults With gMG
This is an open-label, single-arm, multi-center study to evaluate the efficacy, safety, PK, PD, and immunogenicity of eculizumab in Chinese participants with refractory gMG.
- Trial name
- ECU-MG-304 (NCT06764160)
- Testing
- Eculizumab
- Where
- 6 sites in China
- Volunteers
- 15 people
- Sponsor
- Alexion Pharmaceuticals, Inc.