Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis

Alexion Pharmaceuticals

Status and phase

Active, not recruiting

Phase 3

Conditions

Generalized Myasthenia Gravis

Treatments

Combination Product: Placebo

Combination Product: ALXN1720

Study type

Interventional

Funder types

Industry

Identifiers

NCT05556096

2022-000460-21 (EudraCT Number)

ALXN1720-MG-301

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of ALXN1720 for the treatment of generalized MG (gMG) in adults with autoantibodies against acetylcholine receptor (AChR).

Enrollment

261 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of MG with generalized muscle weakness meeting the clinical criteria defined by Myasthenia Gravis Foundation of America (MGFA) Class II, III or IV
Positive serological test for autoantibodies against AChR

Exclusion criteria

History of thymectomy, or any other thymic surgery within 12 months prior to Screening
Untreated thymic malignancy, carcinoma, or thymoma
History of Neisseria meningitidis infection
Pregnancy, breastfeeding, or intention to conceive during the course of the study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

261 participants in 2 patient groups, including a placebo group

ALXN1720

Experimental group

Description:

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.

Treatment:

Combination Product: ALXN1720

Placebo

Placebo Comparator group

Description:

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:

Combination Product: Placebo