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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 February 2021
Main ID:  NCT03770403
Date of registration: 16/11/2018
Prospective Registration: Yes
Primary sponsor: argenx
Public title: A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness. ADAPT+
Scientific 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
Date of first enrolment: March 1, 2019
Target sample size: 151
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT03770403
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
Belgium Canada Czechia Denmark France Georgia Germany Hungary
Italy Japan Netherlands Poland Russian Federation Serbia United States
Contacts
Name:     Antonio Guglietta, MD
Address: 
Telephone:
Email:
Affiliation:  argenx
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Generalized Myasthenia Gravis
Intervention(s)
Biological: ARGX-113
Primary Outcome(s)
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(s)
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]
Secondary ID(s)
2018-002133-37
ARGX-113-1705
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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