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NCT Number: NCT05556096

Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Generalized Myasthenia Gravis Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases Myasthenia Gravis Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, CABA, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALXN1720

Combination Product

Combination product consisting of syringe prefilled with ALXN1720.

Placebo

Combination Product

Combination product consisting of syringe prefilled with placebo.

Primary outcomes

  1. Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Week 26

    Time frame: Baseline, Week 26

Secondary outcomes

  1. Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Week 26

    Time frame: Baseline, Week 26

  2. Percentage of Responders Based on Reduction of the MG-ADL Total Score at Week 26

    Time frame: Baseline up to Week 26

    Response is defined as reduction of the MG-ADL total score by >= 3 points from baseline at Week 26.

  3. Percentage of Responders based on Reduction of the QMG Total Score at Week 26

    Time frame: Baseline up to Week 26

    Response is defined as reduction of the QMG total score by >= 5 points from baseline at Week 26

  4. Change From Baseline in Myasthenia Gravis Composite (MGC) Total Score at Week 26

    Time frame: Baseline, Week 26

  5. Change from Baseline in the QMG total score at Week 4

    Time frame: Baseline, Week 4

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Sep 27, 2022
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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