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Monoclonal Antibodies
ALXN1720 for Myasthenia Gravis
Phase 3
Recruiting
Research Sponsored by Alexion Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of MG with generalized muscle weakness meeting the clinical criteria defined by Myasthenia Gravis Foundation of America (MGFA) Class II, III or IV
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 26
Awards & highlights
Study Summary
This trial will test a new drug, ALXN1720, for the treatment of generalized myasthenia gravis (gMG) in adults. gMG is a disease where the body's immune system attacks healthy cells, causing muscle weakness. The new drug is designed to stop the immune system from attacking healthy cells.
Who is the study for?
This trial is for adults with generalized Myasthenia Gravis (MG), a condition causing muscle weakness. Participants must have specific autoantibodies against AChR and meet certain MG severity criteria. Those who've had thymus surgery within the last year, untreated thymic tumors, or are pregnant/breastfeeding cannot join.Check my eligibility
What is being tested?
The study tests ALXN1720's safety and effectiveness in treating generalized MG compared to a placebo. It targets patients with antibodies against acetylcholine receptors which are linked to this muscle weakness disorder.See study design
What are the potential side effects?
While not specified here, potential side effects of treatments like ALXN1720 could include reactions at the injection site, flu-like symptoms, changes in blood counts or immune system responses that might lead to increased risk of infections or other complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with MG and experience widespread muscle weakness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 26
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 26
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Week 26
Secondary outcome measures
Change From Baseline in Myasthenia Gravis Composite (MGC) Total Score at Week 26
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Week 26
Percentage of Responders Based on Reduction of the MG-ADL Total Score at Week 26
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ALXN1720Experimental Treatment1 Intervention
Participants will receive a weight-based initial (loading) dose of ALXN1720 on Day 1, followed by weight-based maintenance treatment with ALXN1720 on 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 105 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo during the 26-week RCT period, after which they will enter the OLE period of the study and receive ALXN1720.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ALXN1720
2022
Completed Phase 1
~20
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Myasthenia Gravis (MG) target the autoimmune response that leads to the destruction of acetylcholine receptors (AChR) at the neuromuscular junction. Acetylcholinesterase inhibitors, such as pyridostigmine, increase the availability of acetylcholine, enhancing neuromuscular transmission.
Immunosuppressive drugs, like corticosteroids and azathioprine, reduce the production of autoantibodies. Intravenous immunoglobulin (IVIG) and plasmapheresis are used to remove or neutralize circulating antibodies.
Treatments like ALXN1720 specifically inhibit autoantibodies against AChR, directly addressing the underlying cause of the disease. These treatments are crucial for MG patients as they help improve muscle strength and reduce symptoms, significantly enhancing quality of life.
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Who is running the clinical trial?
Alexion Pharmaceuticals, Inc.Lead Sponsor
254 Previous Clinical Trials
40,981 Total Patients Enrolled
10 Trials studying Myasthenia Gravis
1,324 Patients Enrolled for Myasthenia Gravis
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,167 Total Patients Enrolled
9 Trials studying Myasthenia Gravis
1,024 Patients Enrolled for Myasthenia Gravis
AlexionLead Sponsor
246 Previous Clinical Trials
39,021 Total Patients Enrolled
9 Trials studying Myasthenia Gravis
1,024 Patients Enrolled for Myasthenia Gravis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a positive blood test for autoantibodies against AChR.You have had an infection with Neisseria meningitidis in the past.You have a positive blood test for certain antibodies related to muscle function.I had surgery on my thymus gland within the last year.I have an untreated cancer of the thymus.I have been diagnosed with MG and experience widespread muscle weakness.
Research Study Groups:
This trial has the following groups:- Group 1: ALXN1720
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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