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OpenTrials
Completed

NCT Number: NCT04980495

An Open-label Study to Investigate the Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV in Patients With Generalized Myasthenia Gravis

The purpose of this open-label study is to investigate the efficacy, safety, and tolerability of a continuous regimen of efgartigimod compared with a cyclic regimen in participants with Generalized Myasthenia Gravis (gMG).

Participants will receive efgartigimod throughout the study. The participants will be randomized to the continuous regimen arm or to the cyclic regimen arm. The study consists of a part A (regimen comparison period) where participants will continue the treatment based on the treatment regimen arm they were assigned at randomization. Following part A, participants will enter part B (extension period) where all participants will receive efgartigimod in the continuous regimen. The study duration for participants is up to 138 weeks.

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Key information

Conditions

Generalized Myasthenia Gravis Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases MG - Myasthenia Gravis 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 gMG

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigator Site 26 - AT0430002, Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least 18 years of age, at the time of signing the informed consent.
  • Diagnosed with Generalized Myasthenia Gravis (gMG) with confirmed documentation and supported by a physical exam and confirmed seropositivity for anti-acetylcholine receptor antibodies (AChR-Abs).
  • Meets the clinical criteria as defined by the Myasthenia Gravis Foundation of America (MGFA) class II, III, or IV

Exclusion criteria

  • Any other condition that, in the opinion of the investigator, would interfere with an accurate assessment of the clinical symptoms of gMG and/or put the participant at undue risk
  • A thymectomy within 3 months of screening
  • Use of the following prior or concomitant therapies:
  • intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) within 14 days of day 1
  • Rituximab within 6 months of day 1
  • Eculizumab within 1 month of day 1
  • Other monoclonal antibodies (eg, adalimumab, tocilizumab, ixekizumab)

Treatment and study plan

efgartigimod IV

Biological

Intravenous infusions of efgartigimod

Primary outcomes

  1. Mean of the Average MG-ADL Total Score Change From Baseline During the Visit of Week 1 Through Week 21 by Regimen Arm

    Time frame: Up to 21 weeks

    The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment.

Secondary outcomes

  1. Incidence of AEs, SAEs and AESIs

    Time frame: Up to 135 weeks

    AE : adverse event; SAE: serious adverse event; AESI: adverse event of special interest

  2. Change From Baseline in the MG-ADL Total Score Over Time

    Time frame: Up to 126 weeks

    The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment.

  3. Normalized Area Under the Effect Curve (AUEC) of MG-ADL Total Score Improvement From Baseline

    Time frame: Up to 21 weeks

    The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment.

  4. Characterization of MG-ADL Total Score Change From Baseline

    Time frame: Up to 21 weeks

    The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment.

  5. Percentage of Participants Who Have a ≥ 2, 3, 4, or 5 Points Improvement in MG-ADL Total Score From Baseline

    Time frame: Up to 21 weeks

    The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment.

  6. Percentage of Time Participants Have a Change in MG-ADL Total Score of at Least 2 Points From Baseline During Week 4 Through Week 21

    Time frame: From week 4 to week 21

    The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment.

  7. Percentage of Participants Who Achieve MSE, Defined as a MG-ADL Total Score of 0 or 1

    Time frame: Up to 21 weeks

    MSE = minimal symptom expression; The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment.

Sponsors and collaborators

Lead sponsor

argenx

Industry

Registry information

Official study title

A Phase 3b, Randomized, Open-label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia Gravis

Acronym: ADAPT NXT

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Jul 28, 2021
Registry last updated
May 27, 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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