ALXN2050 for Myasthenia Gravis, Generalized

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Myasthenia Gravis, Generalized+2 More
ALXN2050 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Myasthenia Gravis, Generalized
  • Myasthenia Gravis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Myasthenia Gravis, Generalized

Study Objectives

1 Primary · 14 Secondary · Reporting Duration: Week 8

Baseline through Week 8
Maximum Peak Plasma Concentration (Cmax) Of ALXN2050 Over Time
Plasma Factor D Concentration Over Time
Pre-dose Concentration (Ctrough) Of ALXN2050 Over Time
Proportion Of Participants Meeting Prespecified Threshold In The MG-ADL Total Score In Any 4 Consecutive Weeks During The First 8 Weeks And Who Did Not Receive Rescue Therapy
Proportion Of Participants Meeting Prespecified Threshold In The QMG Total Score In Any 4 Consecutive Weeks During The First 8 Weeks And Who Did Not Receive Rescue Therapy
Myasthenia Gravis
Serum Classical Pathway Activity Over Time As Measured By CH50
Complement System Proteins
Baseline, Week 8
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
Change From Baseline In Quality Of Life In Neurological Disorders Fatigue Questionnaire (Neuro-QoL) Fatigue Score At Week 8
Change From Baseline In Quantitative Myasthenia Gravis (QMG) Total Score At Week 8
Week 8
Proportion Of Participants Meeting Prespecified Threshold In The MG-ADL Total Score At Week 8
Proportion Of Participants Meeting Prespecified Threshold In The QMG Total Score At Week 8

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Myasthenia Gravis, Generalized

Trial Design

3 Treatment Groups

ALXN2050: 180 mg
1 of 3
ALXN2050: 120 mg
1 of 3
Placebo
1 of 3
Experimental Treatment
Non-Treatment Group

70 Total Participants · 3 Treatment Groups

Primary Treatment: ALXN2050 · Has Placebo Group · Phase 2

ALXN2050: 180 mg
Drug
Experimental Group · 1 Intervention: ALXN2050 · Intervention Types: Drug
ALXN2050: 120 mg
Drug
Experimental Group · 1 Intervention: ALXN2050 · Intervention Types: Drug
PlaceboPlaceboComparator Group · 2 Interventions: Placebo, ALXN2050 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ALXN2050
2021
Completed Phase 1
~250

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 8

Who is running the clinical trial?

Alexion PharmaceuticalsLead Sponsor
225 Previous Clinical Trials
37,260 Total Patients Enrolled
5 Trials studying Myasthenia Gravis, Generalized
940 Patients Enrolled for Myasthenia Gravis, Generalized

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Positive serologic test for anti AChR antibodies at the Screening Visit.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 22nd, 2021

Last Reviewed: October 27th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
New Jersey100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Clinical Trial Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%