Clinical trials: Myasthenia
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, Neuromuscular Manifestations
Expediting Myasthenia Gravis (MG) Diagnostic Evaluation: A Novel, Proof-of-Concept for Undiagnosed, Symptomatic Patients That Uses Social Media Targeting and Self-Assessment
This is a fully remote, site-less, prospective, observational study enrolling adults in the United States (excluding U.S. territories) with undiagnosed neuromuscular symptoms.
- Conditions
- Myasthenia Gravis, Neuromuscular Manifestations, Neuromuscular Diseases
- Trial name
- NCT06381284
- Testing
- Social media recruitment, Self-Assessment, Follow-up
- Where
- United States
- Volunteers
- 215 people, healthy volunteers welcome
- Sponsor
- ZS Associates
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
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
Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia Gravis
This is an randomized, double-blind, double-dummy trial, and the objective is to compare the efficacy and safety of Mycophenolic acid (MA) and Azathioprine (AZA), immunosuppressive drugs, in myasthenia gravis patients.
- Trial name
- Myfortic (NCT00997412)
- Testing
- Mycophenolic acid, AZA
- Volunteers
- 40 people
- Sponsor
- Qualitix Clinical Research Co., Ltd.
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
Safety, Tolerability and Immunogenic Response of CV-MG01 in Patients With Myasthenia Gravis
Study CV-0002 is the first clinical trial administering CV-MG01 in humans. This clinical trial is a safety and proof-of-concept study (proof of mechanism of action) intended to assess the safety, tolerability and immunogenic…
- Trial name
- NCT02609022
- Testing
- CV-MG01
- Where
- Belgium
- Volunteers
- 24 people
- Sponsor
- CuraVac
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
Study of Pyridostigmine With Ondansetron in Subjects With Anti-AchR Positive Myasthenia Gravis
This is a phase II, single center, randomized, double-blind, placebo-controlled, study in patients with a diagnosis of anti-AchR antibody positive myasthenia gravis.
- Trial name
- NCT04226170
- Testing
- DAS-001
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- DAS-MG, Inc
Ocular Myasthenia Gravis
A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
The purpose of the study is to assess the long-term safety and efficacy of rozanolixizumab in adult study participants with ocular myasthenia gravis.
- Trial name
- MyVisionXT (NCT07465289)
- Testing
- Rozanolixizumab
- Where
- 7 sites in United States, China and 2 more
- Volunteers
- 100 people
- Sponsor
- UCB Biopharma SRL