Safety and Efficacy of ALXN1720 in Adults with Generalized Myasthenia Gravis
Study identifier:ALXN1720-MG-301
ClinicalTrials.gov identifier:NCT05556096
EudraCT identifier:2022-000460-21
CTIS identifier:N/A
Recruiting
Official Title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel, Multicenter Study to Evaluate the Safety and Efficacy of ALXN1720 in Adults with Generalized Myasthenia Gravis
Medical condition
Generalized Myasthenia Gravis
Phase
Phase 3
Healthy volunteers
No
Study drug
-
Sex
All
Estimated Enrollment
254
Study type
Interventional
Age
18 Years - n/a
Date
Study Start Date: 21 Nov 2022
Estimated Primary Completion Date: 05 Aug 2025
Estimated Study Completion Date: 07 Jul 2027
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2024 by Alexion Pharmaceuticals, Inc.
Sponsors
Alexion Pharmaceuticals, Inc.
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: ALXN1720 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. | Combination Product: ALXN1720 Combination product consisting of syringe prefilled with ALXN1720. |
| Placebo Comparator: Placebo Participants will receive placebo during the 26-week RCT period, after which they will enter the OLE period of the study and receive ALXN1720. | Combination Product: Placebo Combination product consisting of syringe prefilled with placebo. |
