Clinical trials: gMG
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
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
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
Generalized Myasthenia Gravis
A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 85 Years With gMG.
The study is a randomized, double-blind, placebo-controlled, multicenter, Phase III study, to evaluate efficacy, safety and tolerability of iptacopan in patients with AChR+ gMG who are on stable SOC treatment.
- Trial name
- NCT06517758
- Testing
- Iptacopan
- Where
- 116 sites in United States, Argentina and 16 more
- Volunteers
- 146 people
- Sponsor
- Novartis Pharmaceuticals
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), 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.
Muscular Diseases, Neuromuscular Manifestations
Study of Anitocabtagene Autoleucel in Participants With Non-Oncology Plasma Cell-Related Diseases
The goal of this clinical study is to learn more about the study drug Anitocabtagene autoleucel (anito-cel), and its safety, tolerability, dosing, and preliminary effectiveness in participants with generalized myasthenia gravis…
- Conditions
- Muscular Diseases, Neuromuscular Manifestations, Autoimmune, Autoimmune Diseases
- Trial name
- NCT06626919
- Testing
- anito-cel, Cyclophosphamide, Fludarabine
- Where
- 14 sites in United States
- Volunteers
- 30 people
- Sponsor
- Kite, A Gilead Company
Generalized Myasthenia Gravis
Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis
The purpose of this 4-period study is to confirm the efficacy and safety of batoclimab in participants with gMG. In Period 1, participants will be randomized 1:1:1 to receive batoclimab 680 milligrams (mg) subcutaneously (SC)…
- Trial name
- NCT05403541
- Testing
- Batoclimab 680 mg SC weekly, Batoclimab 340 mg SC weekly, Batoclimab 340 mg SC bi-weekly
- Where
- 93 sites in United States, Argentina and 14 more
- Volunteers
- 233 people
- Sponsor
- Immunovant Sciences GmbH
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, Anti-AChR Antibody Positive
Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis
The primary objective of the study is to evaluate the effectiveness of Ravulizumab in improving MG-ADL in an early-stage AChR+ gMG population.
- Trial name
- NCT06967480
- Testing
- Ravulizumab
- Where
- 23 sites in Italy
- Volunteers
- 40 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Generalized Myasthenia Gravis (gMG)
An Early Exploratory Clinical Study of GC012F Injection in the Treatment of Refractory Generalized Myasthenia Gravis
This is a single-arm, open-label and early exploratory clinical study, with the purpose to study the safety, tolerability and initial clinical efficacy of GC012F Injection in the treatment of refractory GMG and to evaluate the…
- Trial name
- KY2024-853 (NCT06759948)
- Testing
- GC012F injection
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Chongbo Zhao
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
Generalized Myasthenia Gravis
A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
The purpose of the MycarinGstudy is to demonstrate the clinical efficacy and to assess safety and tolerability of rozanolixizumab in patients with generalized myasthenia gravis (MG).
- Trial name
- NCT03971422
- Testing
- Rozanolixizumab
- Where
- 112 sites in United States, Belgium and 15 more
- Volunteers
- 200 people
- Sponsor
- UCB Biopharma SRL
Myasthenia Gravis, Myasthenia Gravis, Juvenile Form
A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG)
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of eculizumab in the treatment of pediatric refractory gMG based on change from Baseline in the Quantitative Myasthenia Gravis…
- Conditions
- Myasthenia Gravis, Myasthenia Gravis, Juvenile Form, Myasthenia Gravis, Generalized
- Trial name
- NCT03759366
- Testing
- Eculizumab
- Where
- 11 sites in United States, Japan
- Volunteers
- 12 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
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
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