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ARGX-113-2003: 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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-510932-36-00
Acronym
ARGX-113-2003
Enrollment
42
Registered
2024-09-08
Start date
2021-12-21
Completion date
2025-10-06
Last updated
2025-10-15

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

Conditions

Generalized Myasthenia Gravis (gMG)

Brief summary

Mean of the average MG-ADL total score change from baseline during the visit of week (W)1 through W21 by regimen arm

Detailed description

Incidence and severity of AEs, incidence of serious adverse events (SAEs), incidence of AESIs, and changes in laboratory test results, vital sign measurements, and electrocardiogram results, Change from baseline in the MG-ADL total score over time, Normalized area under the effect curve (AUEC) of MG-ADL total score improvement from baseline during the following intervals: day 1 through W7; W7 through W14; W14 through W21; W7 through W21, Characterization of MG-ADL total score change from baseline during the following 5 intervals using mean and standard deviation: W1 through W7; W8 through W14; W15 through W21; W8 through W21; W1 through W21, Number and percentage of participants who have a ≥ 2, 3, 4, or 5 points improvement in MG-ADL total score from baseline during the following 5 intervals: W1 through W7; W8 through W14; W15 through W21; W8 through W21; W1 through W21, Percentage of time participants have a reduction in MG-ADL total score of at least 2 points from baseline during W4 through W21, Number and percentage of participants who achieve minimal symptom expression (MSE), defined as a MG-ADL total score of 0 or 1, in the following 5 intervals: W1 through W7; W8 through W14; W15 through W21; W8 through W21; W1 through W21

Interventions

Sponsors

Argenx
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Mean of the average MG-ADL total score change from baseline during the visit of week (W)1 through W21 by regimen arm

Secondary

MeasureTime frame
Incidence and severity of AEs, incidence of serious adverse events (SAEs), incidence of AESIs, and changes in laboratory test results, vital sign measurements, and electrocardiogram results, Change from baseline in the MG-ADL total score over time, Normalized area under the effect curve (AUEC) of MG-ADL total score improvement from baseline during the following intervals: day 1 through W7; W7 through W14; W14 through W21; W7 through W21, Characterization of MG-ADL total score change from baseline during the following 5 intervals using mean and standard deviation: W1 through W7; W8 through W14; W15 through W21; W8 through W21; W1 through W21, Number and percentage of participants who have a ≥ 2, 3, 4, or 5 points improvement in MG-ADL total score from baseline during the following 5 intervals: W1 through W7; W8 through W14; W15 through W21; W8 through W21; W1 through W21, Percentage of time participants have a reduction in MG-ADL total score of at least 2 points from baseline during W4

Countries

Austria, Belgium, France, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026