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Monoclonal Antibodies
ALXN2050 for Myasthenia Gravis
Phase 2
Waitlist Available
Research Sponsored by Alexion Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at the Screening Visit.
MG-ADL total score must be ≥ 5 at the Screening Visit and at randomization (Day 1) with at least 50% of the score attributed to non-ocular elements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8
Awards & highlights
Study Summary
This trial will test the efficacy and safety of ALXN2050 in people with gMG.
Who is the study for?
This trial is for adults with generalized myasthenia gravis (gMG), a condition causing muscle weakness. Participants must have had gMG symptoms scored at a certain level, been diagnosed at least 3 months prior, and be on stable doses of specific treatments without expecting changes during the study. Those with recent thymic surgery or certain severe kidney issues cannot join.Check my eligibility
What is being tested?
The trial is testing ALXN2050's effectiveness and safety in treating gMG compared to a placebo. Two different doses of ALXN2050 (120 mg and 180 mg) are being studied to see if they can improve muscle strength in participants.See study design
What are the potential side effects?
While the side effects of ALXN2050 are not detailed here, typically such trials monitor for any adverse reactions including but not limited to allergic responses, injection site reactions, fatigue, or exacerbation of gMG symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My myasthenia gravis is moderate to severe.
Select...
My MG-ADL score is 5 or more, mostly due to non-eye symptoms.
Select...
My myasthenia gravis is mild to severe but not requiring intubation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Myasthenia Gravis
Secondary outcome measures
Absolute Values And Change From Baseline In Plasma Concentration Of Bb Fragment Of Complement Factor B At Week 8
Absolute Values And Change From Baseline In Serum Alternative Pathway (AP) Activity At Week 8 As Measured By Wieslab Assay
Change From Baseline In MG-ADL Total Score At Week 8
+11 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: ALXN2050: 180 mgExperimental Treatment1 Intervention
Participants will receive ALXN2050.
Group II: ALXN2050: 120 mgExperimental Treatment1 Intervention
Participants will receive ALXN2050.
Group III: PlaceboPlacebo Group2 Interventions
Participants will receive placebo followed by ALXN2050.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ALXN2050
2021
Completed Phase 1
~250
Find a Location
Who is running the clinical trial?
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,338 Total Patients Enrolled
9 Trials studying Myasthenia Gravis
1,208 Patients Enrolled for Myasthenia Gravis
Alexion Pharmaceuticals, Inc.Lead Sponsor
252 Previous Clinical Trials
41,067 Total Patients Enrolled
10 Trials studying Myasthenia Gravis
1,508 Patients Enrolled for Myasthenia Gravis
AlexionLead Sponsor
246 Previous Clinical Trials
39,192 Total Patients Enrolled
9 Trials studying Myasthenia Gravis
1,208 Patients Enrolled for Myasthenia Gravis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not used tacrolimus or cyclosporine in the last 4 weeks.My myasthenia gravis is moderate to severe.I have been diagnosed with a neuromuscular disorder confirmed by specific tests or responded well to AChEI treatment.I had surgery on my thymus gland within the last year.I haven't used intravenous or subcutaneous immunoglobulin in the last 4 weeks.I was diagnosed with MG over 3 months ago and have test results confirming it.My MG-ADL score is 5 or more, mostly due to non-eye symptoms.I am on a stable dose of certain medications and not expecting changes soon.I have an untreated cancer of the thymus.My myasthenia gravis is mild to severe but not requiring intubation.My health has worsened during the screening period.Your MG-ADL total score must be at least 5, and at least half of the score should come from non-eye-related symptoms at the screening visit and on the first day of randomization.It seems like the criterion is incomplete. Could you please provide more details so that I can accurately summarize it for you?Your kidneys are not working very well, as measured by a test called estimated glomerular filtration rate (eGFR).I am on a stable dose of my current medication and don't expect changes during the trial.You have tested positive for anti AChR antibodies during the screening visit.
Research Study Groups:
This trial has the following groups:- Group 1: ALXN2050: 120 mg
- Group 2: Placebo
- Group 3: ALXN2050: 180 mg
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there extensive implementation of this experiment in the US?
"Currently, 21 trial sites are recruiting patients. These centers span from San Francisco to Nashville and Phoenix with other locations between them. To reduce any potential travel burden, it is suggested that participants select the clinic nearest them for enrolment."
Answered by AI
Has ALXN2050 been given regulatory clearance by the FDA?
"Due to the fact that ALXN2050 is in Phase 2, there is some supporting evidence for safety but none backing its efficacy. Thus, our team assigned it a score of two on the 1-3 scale."
Answered by AI
Are there still opportunities for participants to join this clinical trial?
"As displayed on clinicaltrials.gov, this medical research is now in the recruitment phase having first been posted on December 30th 2021 and recently updated November 11th 2022."
Answered by AI
How many participants are contributing to this research endeavor?
"Affirmative. Clinicaltrials.gov offers proof that this trial, which was initially registered on December 30th 2021, is actively searching for participants. About 70 patients are needed from 21 distinct sites."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
How old are they?
18 - 65
What site did they apply to?
Clinical Trial Site
What portion of applicants met pre-screening criteria?
Met criteria
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