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Trial record 1 of 2 for:    efgartigimod | Myasthenia Gravis | United States
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A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness. (ADAPT+)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03770403
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
argenx BVBA

Tracking Information
First Submitted Date  ICMJE November 16, 2018
First Posted Date  ICMJE December 10, 2018
Last Update Posted Date January 31, 2020
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2020)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 7, 2018)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2020)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2018)
  • 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 ]
  • 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Generalized Myasthenia Gravis
Intervention  ICMJE Biological: ARGX-113
Intravenous administration of ARGX-113
Other Name: efgartigimod
Study Arms  ICMJE Experimental: ARGX-113
Intervention: Biological: ARGX-113
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 7, 2018)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Antonio Guglietta, MD 3293103471 clinicaltrials@argenx.com
Listed Location Countries  ICMJE United States,   Belgium,   Canada,   Czechia,   Denmark,   Georgia,   Germany,   Hungary,   Italy,   Japan,   Netherlands,   Poland,   Russian Federation,   Serbia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03770403
Other Study ID Numbers  ICMJE ARGX-113-1705
2018-002133-37 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party argenx BVBA
Study Sponsor  ICMJE argenx BVBA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Antonio Guglietta, MD argenx BVBA
PRS Account argenx BVBA
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP