Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis

Официальное название

Efficacy and Safety of Nipocalimab vs Efgartigimod for Patients With Generalized Myasthenia Gravis in a Randomized, Open-label, Phase 3b, Interventional Trial Including Within Class Switching From Efgartigimod to Nipocalimab

Обзор

The purpose of this study is to assess how well nipocalimab works when compared to efgartigimod in participants with generalized myasthenia gravis (a condition in which body's immune system mistakenly attacks and damages the connection between nerves and muscles causing muscle weakness).

Вмешательства

• Препарат Nipocalimab
  Nipocalimab will be administered intravenously.
• Препарат Efgartigimod
  Efgartigimod will be administered intravenously.

Первичные конечные точки

• Arms 1 and 2: Averaged Mean Percent Change from Baseline in Total Immunoglobulin G (IgG) Levels Over Weeks 8, 10 and 12 [Срок оценки: Baseline, Weeks 8, 10 and 12]

Вторичные конечные точки (12)

• Arms 1 and 2: Averaged Mean Change from Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score Over Weeks 8, 10 and 12 [Срок оценки: Baseline, Weeks 8, 10 and 12]
• Arms 1 and 2: Mean Percent Change from Baseline in Total IgG Between Arm 1 at EoT and Arm 2 at EoC Based on Clinical Evaluation [Срок оценки: Baseline, EoT (for Arm 1) and EoC (Arm 2) up to Week 12]
• Arms 1 and 2: Mean Percent Change from Baseline in MG-ADL Total Score Between Arm 1 at EoT and Arm 2 at EoC Based on Clinical Evaluation [Срок оценки: Baseline, EoT (for Arm 1) and EoC (Arm 2) up to Week 12]
• Arms 1 and 2: Mean Percent Change from Baseline in Total IgG Levels at Week 8 [Срок оценки: Baseline and Week 8]
• Arms 1 and 2: Mean Change from Baseline in MG-ADL Total Score at Week 8 [Срок оценки: Baseline and Week 8]
• Arms 1 and 2: Averaged Mean Change from Baseline in Quantitative Myasthenia Gravis (QMG) Total Score Over Weeks 8 and 12 [Срок оценки: Baseline, Weeks 8 and 12]
• Arms 1 and 2: Mean Percent Change from Baseline in QMG Total Score Between Arm 1 at EoT and Arm 2 at EoC Based on Clinical Evaluation [Срок оценки: Baseline, EoT (for Arm 1) and EoC (Arm 2) up to Week 12]
• Arms 1 and 2: Mean Change from Baseline in QMG Total Score at Week 8 [Срок оценки: Baseline and Week 8]
• Arms 1 and 2: Percentage of Participants Maintaining >= 2-Point Improvement in MG-ADL Total Score for At Least 6 Weeks During Randomized Treatment Phase [Срок оценки: Baseline up to Week 12]
• Arms 1 and 2: Percentage of Participants Maintaining >= 2-Point Improvement in MG-ADL Total Score for At Least 8 Weeks During Randomized Treatment Phase [Срок оценки: Baseline up to Week 12]
• Arms 1 and 2: Percentage of Participants Maintaining >= 2-Point Improvement in MG-ADL Total Score for 50% of Postbaseline Observations [Срок оценки: Baseline, Week 2 up to Week 12]
• Arms 1 and 2: Percentage of Participants Maintaining >= 2-Point Improvement in MG-ADL Total Score for 75% of Postbaseline Observations [Срок оценки: Baseline, Week 2 up to Week 12]

Критерии участия

Критерии включения

For all arms:

• Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening
• Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized MG (gMG) as defined by the Myasthenia gravis foundation of America (MGFA) clinical classification class II a/b, III a/b, or IV a/b at screening and positive for acetylcholine receptor (AChR) antibodies
• Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of greater than or equal to (>=) 5 with less than (<) 50% of symptoms coming from ocular MG-ADL sub-scores at study screening and baseline (Day 1) visits

Criteria specific to Arms 1 and 2 only:

\- Has suboptimal response to current stable therapy for gMG according to the investigator or has discontinued corticosteroids and/or immunosuppressants/immunomodulators including eculizumab or other novel approved immune agents at least 4 weeks prior to baseline due to intolerance or lack of efficacy

Criteria specific to Arm 3:

\- Treatment with efgartigimod IV or subcutaneous (SC) for >=1 cycle, and the final cycle is consistent with product information

Критерии исключения

• Any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her gMG, or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
• Had a thymectomy within 1 year prior to baseline, or thymectomy is planned during the study
• Currently has a malignancy or has a history of malignancy within 3 years before baseline

Criteria specific to Arms 1 and 2 only:

\- Has received treatment for MG with an FcRn-targeting therapy

Criteria specific to Arm 3 only:

\- Is currently taking IgG monoclonal antibody therapeutics, or Fc-conjugated therapeutic agents, including factor or enzyme replacement, with the exception of efgartigimod

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 14 центров

• Neurology Center of North Orange County — Fullerton
• The Neurology Group — Pomona
• Advanced Neurology of Colorado — Fort Collins
• University of Connecticut — Farmington
• SFM Clinical Research LLC — Boca Raton
• HSHS St. Elizabeth's Hospital — O'Fallon
• Josephson Wallack Munshower Neurology, PC — Indianapolis
• Tulane Center for Clinical Research — New Orleans
• … и ещё 6 центров

Израиль · 2 центра

• Rambam Medical Center — Haifa
• Sourasky Medical Center — Tel Aviv

Швейцария · 1 центр

• HOCH Health Ostschweiz Kantonsspital St.Gallen — Sankt Gallen

Идентификаторы

NCT: NCT07217587 · 80202135MYG3002 · 80202135MYG3002 · 2025-521130-28-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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