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 |
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Recruitment Status :
Completed
First Posted : December 10, 2018
Last Update Posted : July 11, 2022
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Sponsor:
argenx
Information provided by (Responsible Party):
argenx
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Brief Summary:
This is a Long-Term, Single-Arm, Open-Label, Multicenter Phase 3 follow-on trial of the ARGX-113-1704 study to evaluate the safety and tolerability of ARGX-113 in patients with gMG. Patients who have completed at least 1 cycle of treatment and at least 1 year of trial ARGX-113-1705 and have started Part B are eligible to enroll in the open-label trial ARGX-113-2002 to receive efgartigimod by SC administration.
| 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 |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Myasthenia gravis
| Arm | Intervention/treatment |
|---|---|
| Experimental: ARGX-113 |
Biological: ARGX-113
Intravenous administration of ARGX-113
Other Name: efgartigimod |
Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- 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 |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Information from the National Library of Medicine
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
Locations
Show 52 study locations
Sponsors and Collaborators
argenx
Investigators
| Study Director: | Sabine Coppieters, MD | argenx |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | argenx |
| ClinicalTrials.gov Identifier: | NCT03770403 |
| Other Study ID Numbers: |
ARGX-113-1705 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 |
Additional relevant MeSH terms:
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Myasthenia Gravis Muscle Weakness Paresis Muscular Diseases Musculoskeletal Diseases Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Pathologic Processes Paraneoplastic Syndromes, Nervous System |
Nervous System Neoplasms Neoplasms by Site Neoplasms Paraneoplastic Syndromes Autoimmune Diseases of the Nervous System Neurodegenerative Diseases Neuromuscular Junction Diseases Neuromuscular Diseases Autoimmune Diseases Immune System Diseases |