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Monoclonal Antibodies

ALXN2050 for Myasthenia Gravis

Clinical Trial Site, Palo Alto, CA
Targeting 2 different conditionsALXN2050 +1 morePhase 2Waitlist AvailableResearch Sponsored by Alexion Pharmaceuticals, Inc.

Study Summary

This trial will test the efficacy and safety of ALXN2050 in people with gMG.

Eligible Conditions
  • Myasthenia Gravis

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You have a positive blood test for anti AChR antibodies, which confirms you have myasthenia gravis.
Select...
You have been diagnosed with myasthenia gravis using specific tests that show problems with nerve and muscle communication.
Select...
You have been diagnosed with myasthenia gravis based on a positive response to a specific test using a medication called edrophonium chloride.
Select...
Your signs or symptoms of myasthenia gravis improved while taking a specific oral medication, as decided by your doctor.
Select...
You have been diagnosed with Myasthenia Gravis and are classified as Class II to IV by the Myasthenia Gravis Foundation of America.
Select...
Your MG-ADL total score must be at least 5, with at least half of the score coming from non-eye-related symptoms, at the Screening Visit and on the first day of the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 for reporting.

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 more

Trial 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 Pharmaceuticals, Inc.Lead Sponsor
245 Previous Clinical Trials
39,214 Total Patients Enrolled
9 Trials studying Myasthenia Gravis
1,208 Patients Enrolled for Myasthenia Gravis
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,510 Total Patients Enrolled
9 Trials studying Myasthenia Gravis
1,208 Patients Enrolled for Myasthenia Gravis
AlexionLead Sponsor
246 Previous Clinical Trials
39,364 Total Patients Enrolled
9 Trials studying Myasthenia Gravis
1,208 Patients Enrolled for Myasthenia Gravis

Media Library

ALXN2050 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05218096 — Phase 2
Myasthenia Gravis Research Study Groups: ALXN2050: 180 mg, ALXN2050: 120 mg, Placebo
Myasthenia Gravis Clinical Trial 2023: ALXN2050 Highlights & Side Effects. Trial Name: NCT05218096 — Phase 2
ALXN2050 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05218096 — Phase 2

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
Recent research and studies
clinicaltrials.govStudy
Study of ALXN2050 in Adult Participants With Generalized Myasthenia Gravis
2021. "Study of ALXN2050 in Adult Participants With Generalized Myasthenia Gravis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05218096.
All > Oregon > Arkansas
~24 spots leftby Dec 2024
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