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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 below
Select...
I have been diagnosed with MG and experience widespread muscle weakness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 26 for reporting.

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 more

Trial 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

Find a Location

Who is running the clinical trial?

Alexion Pharmaceuticals, Inc.Lead Sponsor
253 Previous Clinical Trials
40,928 Total Patients Enrolled
10 Trials studying Myasthenia Gravis
1,324 Patients Enrolled for Myasthenia Gravis
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,169 Total Patients Enrolled
9 Trials studying Myasthenia Gravis
1,024 Patients Enrolled for Myasthenia Gravis
AlexionLead Sponsor
246 Previous Clinical Trials
39,023 Total Patients Enrolled
9 Trials studying Myasthenia Gravis
1,024 Patients Enrolled for Myasthenia Gravis

Media Library

ALXN1720 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05556096 — Phase 3
Myasthenia Gravis Research Study Groups: ALXN1720, Placebo
Myasthenia Gravis Clinical Trial 2023: ALXN1720 Highlights & Side Effects. Trial Name: NCT05556096 — Phase 3
ALXN1720 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05556096 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many patients are you enrolling in this research project?

"That is accurate. The clinicaltrials.gov website has information revealing that this trial is open for recruitment. The trial was first posted on December 16th, 2022 and was last updated on October 17th, 2022. The study needs 254 individuals from 1 location."

Answered by AI

Are there still positions available for trial participants?

"That is correct, the information on clinicaltrials.gov verifies that this trial is still looking for patients. The trial was posted on December 16th, 2022 and was last updated more recently on October 17th, 2022. So far, 254 people have signed up across 1 location."

Answered by AI

Has ALXN1720 received regulatory approval from the US Food and Drug Administration?

"There is some evidence for efficacy and safety, as this is a Phase 3 trial, so we give it a 3."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis
2022. "Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05556096.
All > Myasthenia Gravis
~119 spots leftby Aug 2025
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