MedDataX Logo

Study of ALXN2050 in Adult Participants With Generalized Myasthenia Gravis

NCT ID: NCT05218096

Last Updated: 2025-01-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-27

Study Completion Date

2024-04-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis

NCT05556096

Generalized Myasthenia Gravis
ACTIVE_NOT_RECRUITING PHASE3

Study of ALXN1830 Administered Subcutaneously in Adults With Generalized Myasthenia Gravis

NCT04982289

Generalized Myasthenia Gravis
WITHDRAWN PHASE2

Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis

NCT00727194

Myasthenia Gravis
TERMINATED PHASE2

Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Chinese Adults With gMG

NCT06764160

Generalized Myasthenia Gravis (gMG) Refractory gMG
COMPLETED PHASE3

An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness

NCT03669588

Generalized Myasthenia Gravis
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study consists of a blinded 8-week Primary Evaluation Period (PEP) and a blinded 26-week Extended Treatment Period (ETP). After completion of 34 weeks of treatment, participants will enter an Open-label Extension (OLE) Period for up to 1.5 years.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Generalized Myasthenia Gravis Myasthenia Gravis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Masking of treatment allocation will be observed until at least Week 34.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ALXN2050: 180 mg

Participants will receive ALXN2050.

Group Type EXPERIMENTAL

ALXN2050

Intervention Type DRUG

Oral tablet.

ALXN2050: 120 mg

Participants will receive ALXN2050.

Group Type EXPERIMENTAL

ALXN2050

Intervention Type DRUG

Oral tablet.

Placebo

Participants will receive placebo followed by ALXN2050.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral tablet.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ALXN2050

Oral tablet.

Intervention Type DRUG

Placebo

Oral tablet.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ACH-0145228 (formerly)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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:

1. Positive serologic test for anti AChR antibodies at the Screening Visit, and
2. Abnormal neuromuscular transmission demonstrated by single fiber electromyography or repetitive nerve stimulation, or
3. Positive response to an AChEI test (eg, edrophonium chloride test), or
4. 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.

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:

1. Intravenous immunoglobulin G or subcutaneous immunoglobulin within the 4 weeks (28 days) prior to the Screening Visit.
2. Use of tacrolimus or cyclosporine within the 4 weeks (28 days) prior to the Screening Visit.
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Phoenix, Arizona, United States

Site Status

Research Site

Aurora, Colorado, United States

Site Status

Research Site

Boca Raton, Florida, United States

Site Status

Research Site

Port Charlotte, Florida, United States

Site Status

Research Site

Tampa, Florida, United States

Site Status

Research Site

Lexington, Kentucky, United States

Site Status

Research Site

New Hyde Park, New York, United States

Site Status

Research Site

Chapel Hill, North Carolina, United States

Site Status

Research Site

Charlotte, North Carolina, United States

Site Status

Research Site

West Chester, Ohio, United States

Site Status

Research Site

Portland, Oregon, United States

Site Status

Research Site

Springfield, Oregon, United States

Site Status

Research Site

Philadelphia, Pennsylvania, United States

Site Status

Research Site

Nashville, Tennessee, United States

Site Status

Research Site

Houston, Texas, United States

Site Status

Research Site

San Antonio, Texas, United States

Site Status

Research Site

Milwaukee, Wisconsin, United States

Site Status

Research Site

Edmonton, Alberta, Canada

Site Status

Research Site

London, Ontario, Canada

Site Status

Research Site

Toronto, Ontario, Canada

Site Status

Research Site

Berlin, , Germany

Site Status

Research Site

Bochum, , Germany

Site Status

Research Site

Düsseldorf, , Germany

Site Status

Research Site

Hamburg, , Germany

Site Status

Research Site

Leipzig, , Germany

Site Status

Research Site

Bergamo, , Italy

Site Status

Research Site

Milan, , Italy

Site Status

Research Site

Napoli, , Italy

Site Status

Research Site

Pisa, , Italy

Site Status

Research Site

Roma, , Italy

Site Status

Research Site

Rome, , Italy

Site Status

Research Site

Udine, , Italy

Site Status

Research Site

Belgrade, , Serbia

Site Status

Research Site

Niš, , Serbia

Site Status

Research Site

Daegu, , South Korea

Site Status

Research Site

Seoul, , South Korea

Site Status

Research Site

Seoul, , South Korea

Site Status

Research Site

Yangsan, , South Korea

Site Status

Research Site

Barcelona, , Spain

Site Status

Research Site

Madrid, , Spain

Site Status

Research Site

Málaga, , Spain

Site Status

Research Site

Murcia, , Spain

Site Status

Research Site

Seville, , Spain

Site Status

Research Site

Hualien City, , Taiwan

Site Status

Research Site

Taipei, , Taiwan

Site Status

Research Site

Taoyuan, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada Germany Italy Serbia South Korea Spain Taiwan

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=ALXN2050-MG-201&attachmentIdentifier=d7fb4ef2-75ad-45ff-9749-51566dbf9ca8&fileName=ALXN2050-MG-201_Abbreviated_CSR_Synopsis_redacted.pdf&versionIdentifier=

Related Info

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-001229-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ALXN2050-MG-201

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis
NCT03920293 COMPLETED PHASE3
A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis
NCT03772587 COMPLETED PHASE2
A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness
NCT02965573 COMPLETED PHASE2
Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study)
NCT01997229 COMPLETED PHASE3
A Study of TAK-079 in People With Generalized Myasthenia Gravis
NCT04159805 COMPLETED PHASE2
A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis
NCT06744920 RECRUITING PHASE3
Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis
NCT05374590 ENROLLING_BY_INVITATION PHASE2/PHASE3
A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis
NCT04650854 COMPLETED PHASE3
Efficacy and Safety of Tolebrutinib (SAR442168) Tablets in Adult Participants With Generalized Myasthenia Gravis
NCT05132569 TERMINATED PHASE3
An Open-label Study to Investigate the Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV in Patients With Generalized Myasthenia Gravis
NCT04980495 COMPLETED PHASE3
Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis
NCT05403541 ACTIVE_NOT_RECRUITING PHASE3
A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)
NCT06909214 RECRUITING PHASE4
FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) Patients
NCT00309088 COMPLETED PHASE3
An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis
NCT03896295 TERMINATED PHASE2
A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 75 Years With gMG.
NCT06517758 RECRUITING PHASE3
BeatMG: Phase II Trial of Rituximab In Myasthenia Gravis
NCT02110706 COMPLETED PHASE2
Study Comparing Two Tapering Strategies of Prednisone in Myasthenia Gravis
NCT00987116 COMPLETED PHASE4
Extension Study of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis
NCT02301624 COMPLETED PHASE3
The Evaluation of Belimumab in Myasthenia Gravis (MG)
NCT01480596 COMPLETED PHASE2
Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis
NCT06414954 RECRUITING PHASE2
A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis
NCT06298552 ACTIVE_NOT_RECRUITING PHASE3
A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.
NCT03770403 COMPLETED PHASE3
Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis
NCT03052751 COMPLETED PHASE2
Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis
NCT04818671 COMPLETED PHASE3
Pharmacodynamic Study of CK-2017357 in Patients With Generalized Myasthenia Gravis
NCT01268280 TERMINATED PHASE2