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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 : Recruiting
First Posted : December 10, 2018
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
argenx BVBA

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.

Condition or disease Intervention/treatment Phase
Generalized Myasthenia Gravis Biological: ARGX-113 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
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
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ARGX-113 Biological: ARGX-113
Intravenous administration of ARGX-113
Other Name: efgartigimod




Primary Outcome Measures :
  1. Safety and Tolerability as measured by the incidence of treatment emergent (serious) adverse events in the AChR-positive population. [ Time Frame: Up to 1 year ]

Secondary Outcome Measures :
  1. 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 1 year ]
  2. Safety and Tolerability as measured by the incidence of treatment emergent (serious) adverse events after each treatment period in the AChR-Ab seropositive patients. [ Time Frame: Up to 1 year ]
  3. Safety and Tolerability as measured by the incidence of treatment emergent (serious) adverse events after each treatment period in the overall population (AChR-Ab seropositive patients and AChR-Ab seronegative patients). [ Time Frame: Up to 1 year ]


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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:

  1. Patients with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.
  2. 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:

  1. 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.
  2. 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.
  3. 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.
  4. 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


Contacts
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Contact: Antonio Guglietta, MD 3293103471 clinicaltrials@argenx.com

Locations
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United States, California
Investigator Site 8 Recruiting
Los Angeles, California, United States, 90033
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
United States, Florida
Investigator Site 4 Recruiting
Tampa, Florida, United States, 33612
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
United States, North Carolina
Investigator Site 2 Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
United States, Tennessee
Investigator Site Recruiting
Cordova, Tennessee, United States, 38018
Contact: Antonio Guglietta, MD    329-310-3471    clinicaltrials@argenx.com   
United States, Texas
Investigator Site 3 Recruiting
San Antonio, Texas, United States, 78229
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Belgium
Investigator Site 11 Recruiting
Edegem, Belgium, 2650
Contact: Antontio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Investigator Site 7 Recruiting
Ghent, Belgium, 9000
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Italy
Investigator Site 10 Recruiting
Milano, MI, Italy, 20133
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Investigator Site 5 Recruiting
Napoli, Italy, 80131
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Poland
Investigator Site 9 Recruiting
Gdańsk, Poland, 80-952
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Investigator Site 6 Recruiting
Kraków, Poland, 31-505
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Sponsors and Collaborators
argenx BVBA
Investigators
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Study Director: Antonio Guglietta, MD argenx BVBA

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Responsible Party: argenx BVBA
ClinicalTrials.gov Identifier: NCT03770403     History of Changes
Other Study ID Numbers: ARGX-113-1705
2018-002133-37 ( EudraCT Number )
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Muscle Weakness
Paresis
Myasthenia Gravis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases