A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness. (ADAPT+)
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|ClinicalTrials.gov Identifier: NCT03770403|
Recruitment Status : Completed
First Posted : December 10, 2018
Last Update Posted : July 11, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Generalized Myasthenia Gravis||Biological: ARGX-113||Phase 3|
Expanded Access : An investigational treatment associated with this study has been approved for sale to the public. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||151 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness|
|Actual Study Start Date :||March 1, 2019|
|Actual Primary Completion Date :||June 23, 2022|
|Actual Study Completion Date :||June 30, 2022|
Intravenous administration of ARGX-113
Other Name: efgartigimod
- Safety and Tolerability as measured by the incidence of treatment emergent (serious) adverse events in the AChR-positive population. [ Time Frame: Up to 3 years ]
- Safety and Tolerability as measured by the incidence of treatment emergent (serious) adverse events in the overall population (AChR-Ab seropositive patients and AChR-Ab seronegative patients). [ Time Frame: Up to 3 years ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.
- Patients who participated in trial ARGX-113-1704 and are eligible for roll over, as specified in the protocol.
Other more specific inclusion criteria are further defined in the protocol.
- Patients who discontinued early from trial ARGX-113-1704 or patients who discontinued early from randomized treatment for pregnancy or rescue reasons or an (S)AE that might jeopardize the safety of the patient in that trial.
- Pregnant and lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing. Women or childbearing potential should have a negative urine pregnancy test at SEB.
- Male patients who are sexually active and do not intend to use effective methods of contraception during the trial or within 90 days after the last dosing or male patients who plan to donate sperm during the trial or within 90 days after the last dosing.
- Patients with known Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) seropositivity.
Other, more specific exclusion criteria are further defined in the protocol.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03770403
|Study Director:||Sabine Coppieters, MD||argenx|
|Other Study ID Numbers:||
2018-002133-37 ( EudraCT Number )
|First Posted:||December 10, 2018 Key Record Dates|
|Last Update Posted:||July 11, 2022|
|Last Verified:||July 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Nervous System Diseases
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Immune System Diseases