Safety and Efficacy of ALXN1720 in Adults with Generalized Myasthenia Gravis.

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. - Safety and Efficacy of ALXN1720 in Adults with Generalized Myasthenia Gravis.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000460-21-AT

Enrollment

254

Registered

2022-11-18

Start date

2023-02-09

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Myasthenia Gravis MedDRA version: 21.1 Level: PT Classification code 10028417 Term: Myasthenia gravis System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Code: ALXN1720 Pharmaceutical Form: Solution for injection INN or Proposed INN: gefurulimab Current Sponsor code: ALXN1720 Other descriptive name: Humanised VHH-type bispecific antibody again

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Must be = 18 years of age at the time of signing the informed consent - 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 228 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of ALXN1720 compared with placebo in the treatment of gMG based on change in MG-ADL total score;Secondary Objective: To assess the efficacy of ALXN1720 compared with placebo in the treatment of gMG based on change in QMG total score;Primary end point(s): Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Week 26 ;Timepoint(s) of evaluation of this end point: At Week 26	—

Measure

Time frame

Main Objective: To assess the efficacy of ALXN1720 compared with placebo in the treatment of gMG based on change in MG-ADL total score;Secondary Objective: To assess the efficacy of ALXN1720 compared with placebo in the treatment of gMG based on change in QMG total score;Primary end point(s): Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Week 26 ;Timepoint(s) of evaluation of this end point: At Week 26

—

Secondary

Measure	Time frame
Secondary end point(s): - Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Week 26 -Percentage of Responders Based on Reduction of the MG-ADL Total Score at Week 26 -Percentage of Responders based on Reduction of the QMG Total Score at Week 26 - Change From Baseline in Myasthenia Gravis Composite (MGC) Total Score at Week 26 ;Timepoint(s) of evaluation of this end point: At week 26	—

Measure

Time frame

Secondary end point(s): - Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Week 26 -Percentage of Responders Based on Reduction of the MG-ADL Total Score at Week 26 -Percentage of Responders based on Reduction of the QMG Total Score at Week 26 - Change From Baseline in Myasthenia Gravis Composite (MGC) Total Score at Week 26 ;Timepoint(s) of evaluation of this end point: At week 26

—

Countries

Argentina, Austria, Brazil, Canada, China, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Netherlands, Poland, Portugal, Serbia, Spain, Switzerland, Taiwan, Türkiye, United Kingdom, United States

Contacts

Public ContactEuropean Clinical Trial Information

Alexion Europe SAS

clinicaltrials.eu@alexion.com+331 47 10 06 15

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026