Clinical trials: Myasthenia Gravis Generalized
Generalized Myasthenia Gravis
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Myasthenia Gravis
During this pilot study, the investigators will examine the effects of whole-body electrical muscle stimulation exercise (WB-EMS Exercise) on neuromuscular junction (NMJ) transmission and fatigability in adults with Generalized…
- Trial name
- NCT06064695
- Testing
- Whole-body Electrical Muscle Stimulation Exercise
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- University of Missouri-Columbia
Generalized Myasthenia Gravis
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG)
The primary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of inebilizumab administered in pediatric participants with gMG, and to assess the safety and tolerability of…
- Trial name
- THYME (NCT06987539)
- Testing
- Inebilizumab
- Where
- 14 sites in United States, Argentina and 6 more
- Volunteers
- 15 people
- Sponsor
- Amgen
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.
Myasthenia Gravis, Generalized
Markers of Favorable Response to Complement Inhibitors Therapy
Myasthenia gravis is an autoimmune neurological disease caused by autoantibodies primarily directed against components of the postsynaptic membrane of the neuromuscular junction.
- Trial name
- OPTIMISE (NCT06455709)
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
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
A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis
The purpose of the study is to assess the safety and tolerability of subcutaneous (sc) administration of rozanolixizumab in pediatric participants aged ≥2 to <18 years with generalized Myasthenia Gravis (gMG).
- Trial name
- roMyG (NCT06149559)
- Testing
- rozanolixizumab
- Where
- 9 sites in Italy, Japan and 2 more
- Volunteers
- 14 people
- Sponsor
- UCB Biopharma SRL
Generalized Myasthenia Gravis
Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis
The purpose of this study is to investigate the Pharmacodynamics (PD), Pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20…
- Trial name
- ADAPTsc (NCT04735432)
- Testing
- efgartigimod PH20 SC, efgartigimod IV
- Where
- 47 sites in United States, Belgium and 9 more
- Volunteers
- 110 people
- Sponsor
- argenx
Neuromyelitis Optica Spectrum Disorders, Myasthenia Gravis, Generalized
Universal CAR-T Cells in Patients with Refractory Autoimmune Diseases of the Nervous System.
This is an open label, single-site, dose-escalation study in up to 25 participants with refractory autoimmune diseases of nervous system.
- Conditions
- Neuromyelitis Optica Spectrum Disorders, Myasthenia Gravis, Generalized, Multiple Sclerosis, Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- Trial name
- NCT06485232
- Testing
- Universal BCMA CAR-T, Universal CD19 CAR-T, Universal BCMA CAR-T; Universal CD19 CAR-T
- Where
- China
- Volunteers
- 25 people
- Sponsor
- Xuanwu Hospital, Beijing
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
A Phase II Study of SHR-2173 Injection in Patients With Myasthenia Gravis
This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of SHR-2173 compared to placebo as an add-on…
- Trial name
- NCT07622342
- Testing
- SHR-2173 injection
- Where
- 2 sites in China
- Volunteers
- 60 people
- Sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
Generalized Myasthenia Gravis
A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis
This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in participants with generalized myasthenia gravis (gMG).
- Trial name
- NCT04963270
- Testing
- Satralizumab
- Where
- 76 sites in United States, Argentina and 15 more
- Volunteers
- 188 people
- Sponsor
- Hoffmann-La Roche
Myasthenia Gravis, Generalized
A Study to Evaluate the Efficacy of CV-MG01 (Myasterix) in Myasthenia Gravis
Study CV-0003 will be the second clinical trial administering CV-MG01 in humans. This will be a phase 2/3 proof-of-efficacy therapeutic confirmatory study following the proof-of-concept exploratory phase 1 study (CV-0002).
- Trial name
- NCT03165435
- Testing
- CV-MG01
- Where
- Belgium
- Sponsor
- CuraVac
Myasthenia Gravis, Generalized
A Phase 3 Study to Evaluate Claseprubart in Adults With Generalized Myasthenia Gravis (EMERGE)
The purpose of this Phase 3 study is to demonstrate the efficacy, safety, and tolerability of claseprubart in participants with generalized myasthenia gravis (gMG).
- Trial name
- NCT07647510
- Testing
- Claseprubart
- Where
- 12 sites in United States, Georgia and 1 more
- Volunteers
- 195 people
- Sponsor
- Dianthus Therapeutics
Myasthenia Gravis
Evaluate the Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis
The primary study objective is to evaluate medium- and long-term safety of HBM9161 in combination with background treatment for gMG patients through the observation on adverse events and laboratory abnormalities during study…
- Trial name
- NCT05332210
- Testing
- HBM9161 Injection (680mg)
- Where
- China
- Volunteers
- 111 people
- Sponsor
- Harbour BioMed (Guangzhou) Co. Ltd.
Myasthenia Gravis Generalized
Quantification of Change in MG Disease Activity in Individuals With Generalized Myasthenia Gravis (gMG) After Administration of VYVGART® or VYVGART Hytrulo® Using BioDigit MG
Evaluate the feasibility of using digital health technologies to monitor disease symptoms over time in individuals with gMG who are initiating treatment with VYVGART® or VYVGART Hytrulo®.
- Trial name
- BioDigit MG-03 (NCT07226830)
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- BioSensics
Generalized Myasthenia Gravis
A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (UPSTREAM MG)
The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of generalized myasthenia gravis.
- Trial name
- NCT06456580
- Testing
- Telitacicept
- Where
- 120 sites in United States, Argentina and 13 more
- Volunteers
- 191 people
- Sponsor
- Vor Biopharma
Generalized Myasthenia Gravis, Myasthenia Gravis
Study of ALXN2050 in Adult Participants With Generalized Myasthenia Gravis
This study will evaluate the efficacy and safety of ALXN2050 (120 milligrams [mg], 180 mg) in participants with generalized myasthenia gravis (gMG). Safety will be monitored throughout the study.
- Trial name
- NCT05218096
- Testing
- ALXN2050
- Where
- 46 sites in United States, Canada and 6 more
- Volunteers
- 70 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Generalized Myasthenia Gravis
An Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneous Zilucoplan in Participants With Generalized Myasthenia Gravis Who Were Previously Receiving Intravenous Complement Component 5 Inhibitors
The purpose of the study is to evaluate the safety and tolerability of switching from intravenous (IV) complement component 5 (C5) inhibitors to subcutaneous (SC) Zilucoplan in study participants with generalized myasthenia…
- Trial name
- NCT05514873
- Testing
- zilucoplan (RA101495)
- Where
- 12 sites in United States
- Volunteers
- 26 people
- Sponsor
- UCB Biopharma SRL
Myasthenia Gravis, Myasthenia Gravis, Generalized
A Pilot Study to Explore the Role of Gut Flora in Myasthenia Gravis
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.
- Trial name
- NCT04224506
- Testing
- No intervention
- Where
- United States
- Sponsor
- ProgenaBiome