Cabaletta Bio
PI: Dr. Dimachkie University of Kansas Health Center Clinicaltrials.gov identifier: NCT05451212
A Phase 1, Open-label, Safety and Dose-finding Study of Autologous Muscle-specific Tyrosine Kinase Chimeric Autoantibody Receptor T Cells (MuSK-CAART) in Subjects With Anti-MuSK-antibody-positive Myasthenia Gravis
Experimental: MuSK-CAART
Cohort A: Infusion of MuSK-CAART at various dose levels with or without pre-treatment (6 groups planned).
Cohort B: Infusion of MuSK-CAART at the dose regimen selected from Part A
Total: 24 patients
For more information contact:
Andrew Heim aheim2@kumc.edu
Immunovant MG
PI: Dr. Pasnoor
University of Kansas Health Center
ClinicalTrials.gov Identifier: NCT05403541
A Phase 3, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis (gMG)
Experimental: Batoclimab
Period 1 arms:
Batoclimab 680 mg SC weekly
Batoclimab 340 mg SC weekly
Matching Placebo SC
Period 2 arms:
Batoclimab 340 mg SC weekly
Batoclimab 340 mg SC bi-weekly
Matching Placebo SC
Total enrollment: 210 participants
For more information:
Nick Staudenmier nstaudenmier@kumc.edu
Clinical Trials
ME & MG Open
Eligibility Critiera
Aged 18 + years old
Diagnosis of gMG with positive serologic test for anti-AChR autoantibody at screening who has read the information sheet and signed the informed consent form
Owns a personal smartphone which version is above 14 for IOS and 8 for Android included
Able to use a smartphone
Able to perform the ME&MG tests (based on investigator's judgment)
Able to read language in which the mobile application is available (English, Spanish, German) and able to understand pictograms
For more information click here.
The MGA maintains communication with representatives from clinical research studies in efforts to keep the public informed about potential trials MG patients can participate in. Take a look at some of the latest studies in our area below or visit the clinical trials database to discover all the research studies conducted around the world.
ALXN1720 – MG
PI: Dr. Dimachkie University of Kansas Health Center ClinicalTrials.gov Identifier: NTC
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel, Multicenter Study to Evaluate the Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis
Experimental: ALXN1720
Participants will receive a weight-based maintenance treatment with ALXN1720 on Day 1, followed by weight-based maintenance treatment of ALXN1720 on Week 1 (Day 8) and once every week (Q1W) thereafter for a total of 26 weeks. Following this randomized controlled treatment (RCT) period, all participants will receive ALXN1720 in an open-label extension (OLE) period of 96 weeks.
Placebo Comparator: Placebo
Participants will receive placebo during the 26-week RCT period, after which they will enter the OLE period of the study and receive ALXN1720.
Total Enrollment: 254 participants
For more information:
Nick Staudenmier nstaudenmier@kumc.edu
Viela Bio
PI: Dr. Pasnoor
University of Kansas Health Center
ClinicalTrials.gov identifier: NCT04524273
A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study With Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults With Myasthenia Gravis
Experimental: Inebilizumab, (AChR-Ab+) MG
Participants will receive inebilizumab administered intravenously (IV) on Days 1, 15, and 183 of the randomized controlled period.
During the open-label period, participants will receive inebilizumab administered IV on Days 1 and 183.
Placebo Comparator: Placebo, (AChR-Ab+) MG
Participants will receive placebo administered IV on Days 1 and 15 and on Day 183 of the randomized controlled period.
During the open label period, participants will receive inebilizumab administered IV on Days 1, 15 and 183.
Experimental: Inebilizumab, (MuSK-Ab+) MG
Participants will receive inebilizumab administered IV on Days 1 and 15 of the randomized controlled period.
During the open-label period, participants will receive inebilizumab administered IV on Days 1 and 183
Placebo Comparator: Placebo, (MuSK-Ab+) MG
Participants will receive placebo administered IV on Days 1 and 15 of the randomized controlled period.
During the open label period, participants will receive inebilizumab administered IV on Days 1, 15 and 183
For more information contact:
Lilli Saavedra lsaavedra2@kumc.edu
Cartesian
PI: Dr. Pasnoor ClinicalTrials.gov Identifier: NCT04146051
University of Kansas Health Center
Autologous T-Cells Expressing A Chimeric Antigen Receptor Directed To B-Cell Maturation Antigen (BCMA) In Patients With Generalized Myasthenia Gravis (MG)
Phase 2 Trial
Experimental: Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA (Descartes-08)
Experimental: Phase 1b Dose-Escalation
Intervention: Descartes-08
Experimental: Phase IIa Expansion
Intervention: Descartes-08
Placebo Comparator: Phase IIb Randomized Control Trial
Intervention: Descartes-08
Total enrollment: 30 participants
For more information contact:
Ali Ciersdorff aciersdorff@kumc.edu
ALXN2050 - MG
Eligibility Criteria
AGES ELIGIBLE FOR STUDY
18 Years and older (ADULT, OLDER_ADULT)
Key Inclusion Criteria:
Diagnosed with MG at least 3 months (90 days) prior to the date of the Screening Visit. Confirmation of MG must be made via the following:
Positive serologic test for anti AChR antibodies at the Screening Visit, and
Abnormal neuromuscular transmission demonstrated by single fiber electromyography or repetitive nerve stimulation, or
Positive response to an AChEI test (eg, edrophonium chloride test), or
Improvement of signs or symptoms related to MG during treatment with an oral AChEI, as determined by the treating physician
Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at the Screening Visit.
MG-ADL total score must be ≥ 5 (with at least 50% of the score attributed to non-ocular elements) at the Screening Visit and at randomization (Day 1).
Participants receiving treatment with protocol-specified immunosuppressive therapies, corticosteroids, or acetylcholinesterase inhibitors must have been receiving treatment and on a stable dose prior to the date of the Screening Visit, with no changes to the regimen expected during screening, the PEP, and/or the ETP.
Key Exclusion Criteria:
Estimated glomerular filtration rate ≤ 30 milliliters/minute/1.73 squared meters during Screening calculated by Chronic Kidney Disease Epidemiology Collaboration.
History of thymectomy, thymomectomy, or any other thymic surgery within 12 months prior to the Screening Visit.
Any untreated thymic malignancy, carcinoma, or thymoma. Participants with a history of treated thymic malignancy or carcinoma are eligible for enrollment if they meet pre-specified conditions outlined in the protocol.
Clinical features consistent with Clinical Deterioration at the time of the Screening Visit or at any time during the Screening Period prior to randomization (Day 1).
Use of the following within the time periods specified below:
Intravenous immunoglobulin G or subcutaneous immunoglobulin within the 4 weeks (28 days) prior to the Screening Visit.
Use of tacrolimus or cyclosporine within the 4 weeks (28 days) prior to the Screening Visit.
Recruiting for children
Argenx ClinicalTrials.gov Identifier: NCT05374590
Evaluating Long-term Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis
A Long-term, Single-Arm, Open-label, Multicenter, Follow-on Trial of ARGX-113-2006 to Evaluate Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis
Ages 2-18
Contact: Sabine Coppieters, MD 857-350-4834 ClinicalTrials@argenx.com
Recruiting in St. Louis, Missouri & Little Rock, Arkansas
UCB MG0017
PI: Dr. Pasnoor
University of Kansas Health Center
Clinicaltrials.gov Identifier: NCT05514873
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
Experimental: 0.3 mg/kg zilucoplan (RA101495)Study participants will be treated with subcutaneous zilucoplan (0.3mg/kg/day)
Total: 20 patients
For more information:
Nicholas Staudenmier nstaudenmier@kumc.edu
Janssen
PI: Dr. Statland
University of Kansas Health Center
ClinicalTrials.gov Identifier: NCT05265273
An Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
Experimental: Nipocalimab
Participants aged 2 to less than [<] 18 years of age will receive nipocalimab once every two weeks for 24 weeks. After Week 24, all participants will have the option to enroll in long term extension (LTE).
Nipocalimab will be administered as an IV infusion
Total enrollment: 12 participants
For more information contact:
Katie Lillig kjennens2@kumc.edu