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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522492-28-00 | EU Trial (CTIS) Number |
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This study is part of the ADAPT Forward platform study (NCT07294170). ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life.
The aim of this ISA1 is to evaluate the safety and therapeutic relevance of empasiprubart as add-on therapy to efgartigimod in participants with AChR-Ab seropositive generalized myasthenia gravis.
The ADAPT Forward master protocol is registered on https://clinicaltrials.gov/study/NCT07294170
Once the master protocol and ISA1 screening periods are completed, eligible participants can enroll in the run-in period (part A) where they will receive efgartigimod IV. Eligible participants can then continue to the add-on period (part B) where they will receive both efgartigimod IV and empasiprubart IV.
Participants who are not eligible for part B will continue directly to the safety follow-up period (part C) where they will receive efgartigimod IV only.
The study duration for each participant is approximately up to 54 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efgartigimod IV + Empasiprubart IV | Experimental | Participants receive efgartigimod IV in part A, B and C and empasiprubart IV in part B |
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| Efgartigimod IV (part A + C) | Experimental | Participants not eligible for part B, receiving efgartigimod IV in part A and C |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efgartigimod IV | Biological | Intravenous infusion of efgartigimod |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events and serious adverse events in parts A and B | Up to 21 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| MG-ADL total score change from baseline at week 18 in part B (cycle 2 day 29) compared with MG ADL total score change from baseline at week 4 in part A | The Myasthenia Gravis Activities of Daily Living (MG- ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (normal symptoms) to 24 (most severe symptoms) | Up to 18 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabine Coppieters, MD | Contact | 857-350-4834 | clinicaltrials@argenx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profound Research LLC - Carlsbad | Recruiting | Carlsbad | California | 92011 | United States |
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| Empasiprubart IV | Biological | Intravenous infusion of empasiprubart |
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| Proportion of participants reaching MSE at any point in part B cycles 1 and 2, and part B cycles 1 or 2 | MSE: Minimal symptom expression | Up to 21 weeks |
| MG-ADL total score changes from baseline over time in part B compared with part A | The Myasthenia Gravis Activities of Daily Living (MG- ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (normal symptoms) to 24 (most severe symptoms) | Up to 21 weeks |
| QMG total score change from baseline at week 18 in part B (cycle 2 day 29) compared with QMG total score change from baseline at week 4 in part A | The Quantitative myasthenia gravis (QMG) includes 13 items that measure endurance or fatigability and accounts for fluctuations in disease state. The total score ranges from 0 (no disease severity) to 39 (highest disease severity) | Up to 18 weeks |
| QMG total score changes from baseline over time in part B compared with part A | The Quantitative myasthenia gravis (QMG) includes 13 items that measure endurance or fatigability and accounts for fluctuations in disease state. The total score ranges from 0 (no disease severity) to 39 (highest disease severity) | Up to 21 weeks |
| Proportion of participants who have a 50% MG ADL total score improvement in part B cycles 1 and 2 | The Myasthenia Gravis Activities of Daily Living (MG ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (normal symptoms) to 24 (most severe symptoms) | Up to 21 weeks |
| Proportion of participants who have positive PASS in part B cycles 1 and 2, and part B cycles 1 or 2 | PASS: Patient acceptable symptom state | Up to 21 weeks |
| Visionary Investigators Network | Recruiting | Miami | Florida | 33176 | United States |
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| University of South Florida | Recruiting | Tampa | Florida | 33620 | United States |
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| Henry Ford Health Systems | Active, not recruiting | Detroit | Michigan | 48202-2608 | United States |
| Dent Neurologic Institute - Amherst | Recruiting | Amherst | New York | 14226 | United States |
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| Duke Early Phase Clinical Research Unit - PPDS | Active, not recruiting | Durham | North Carolina | 27710-0001 | United States |
| Ohio State Martha Morehouse Outpatient Care | Recruiting | Columbus | Ohio | 43221-3502 | United States |
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| Erlanger Health System | Recruiting | Chattanooga | Tennessee | 37403 | United States |
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| National Neuromuscular Research Institute | Recruiting | Austin | Texas | 78756 | United States |
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| University of Texas- San Antonio - Health Science Center - PPDS | Recruiting | San Antonio | Texas | 78229 | United States |
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| UZ Leuven - PPDS | Recruiting | Leuven | 3000 | Belgium |
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| ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII | Recruiting | Bergamo | Lombardy | 24127 | Italy |
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| MICS Centrum Medyczne Bydgoszcz | Recruiting | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | Poland |
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| Centrum Medyczne Neurologia Slaska | Recruiting | Katowice | Silesian Voivodeship | 40-689 | Poland |
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| Hospital Regional Universitario de Malaga - Hospital General | Recruiting | Málaga | Malaga | 29010 | Spain |
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| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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