Clinical trials: Myasthenia Gravis
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
Myasthenia Gravis
Myasthenia Gravis Inebilizumab Trial
Randomized, double-blind, placebo-controlled, Phase 3, parallel-group study with optional open-label extension.
- Trial name
- MINT (NCT04524273)
- Testing
- inebilizumab
- Where
- 104 sites in United States, Argentina and 17 more
- Volunteers
- 238 people
- Sponsor
- Amgen
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.
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.
Myasthenia Gravis, Ocular
A Study of Telitacicept in Patients With Ocular Myasthenia Gravis (OMG)
This is a Phase III, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Telitacicept for the treatment of Ocular Myasthenia Gravis (OMG).Approximately 120 eligible…
- Trial name
- NCT07249632
- Testing
- Telitacicept
- Where
- China
- Volunteers
- 120 people
- Sponsor
- RemeGen Co., Ltd.
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.
Generalized Myasthenia Gravis
A Study to Evaluate the Safe and Effective Use of a Zilucoplan Auto-injector by Study Participants With Generalized Myasthenia Gravis
The purpose of this study is to evaluate the effectiveness, safety and tolerability of zilucoplan auto-injector (ZLP-AI) self-administration.
- Trial name
- NCT06471361
- Testing
- Zilucoplan
- Where
- 11 sites in United States, Poland and 1 more
- Volunteers
- 31 people
- Sponsor
- UCB Biopharma SRL
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
Registry of Participants With Generalized Myasthenia Gravis Treated With Alexion C5 Inhibition Therapies (C5ITs)
Long-term, multicenter, multinational, observational, registry of patients with gMG that is designed to collect data on clinical outcomes and safety in patients prescribed Alexion C5 inhibitor therapies (C5IT) such as eculizumab…
- Trial name
- NCT04202341
- Where
- 51 sites in United States, Austria and 5 more
- Volunteers
- 500 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Myasthenia Gravis
A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be…
- Trial name
- NCT06298565
- Testing
- efgartigimod
- Where
- 35 sites in United States, Austria and 4 more
- Volunteers
- 680 people
- Sponsor
- argenx
Myasthenia Gravis, CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.
This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy.
- Trial name
- NCT06299748
- Testing
- Efgartigimod
- Where
- 4 sites in United States, Germany and 2 more
- Volunteers
- 279 people
- Sponsor
- argenx
Refractory Myasthenia Gravis
Efficacy and Safety of HN2301 in Refractory Myasthenia Gravis(MG)
This is an investigator-initiated trial designed to evaluate the safety, and efficacy of HN2301 in refractory myasthenia gravis
- Trial name
- NCT06965309
- Testing
- HN2301 injection
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Shenzhen MagicRNA Biotechnology Co., Ltd
Myasthenia Gravis
A Phase 1b/2 Study of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis
The goal of this clinical trial is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and potential efficacy of IM-101 in adult participants with AChR antibody-positive gMG.
- Trial name
- Synergy-MG (NCT07250750)
- Testing
- IM-101 Part A, IM-101 Part B
- Where
- 25 sites in United States, Bulgaria and 4 more
- Volunteers
- 96 people
- Sponsor
- ImmunAbs Inc.
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.
Myasthenia Gravis Generalised
Detecting Fatigue From Voice in Generalised Myasthenia Gravis
The goal of this observational study is to learn if computer analysis of voice recordings can detect a type of exhaustion called "central fatigue" in adults with generalised myasthenia gravis.
- Trial name
- NCT07033559
- Volunteers
- 240 people
- Sponsor
- Thymia Limited
Generalized Myasthenia Gravis
Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis
The purpose of this study is to evaluate the long-term safety and tolerability of efgartigimod PH20 SC 1000 mg, and the clinical efficacy, PD, pharmacokinetics (PK), immunogenicity, impact on the quality of life (QoL) of the…
- Trial name
- ADAPTSC+ (NCT04818671)
- Testing
- efgartigimod PH20 SC
- Where
- 47 sites in United States, Belgium and 10 more
- Volunteers
- 184 people
- Sponsor
- argenx