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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: EUCTR
Last refreshed on: 28 February 2019
Main ID:  EUCTR2018-002133-37-HU
Date of registration: 22/11/2018
Prospective Registration: Yes
Primary sponsor: argenx BVBA
Public title: A safety and tolerability study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.
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: 28/01/2019
Target sample size: 150
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-002133-37
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Belgium Canada Czech Republic Denmark France Germany Hungary Italy
Japan Netherlands Poland Russian Federation Sweden United Kingdom United States
Contacts
Name: Regulatory affairs   
Address:  Industriepark Zwijnaarde 7 B 9052 Zwijnaarde Belgium
Telephone:
Email: regulatory@argenx.com
Affiliation:  argenx BVBA
Name: Regulatory affairs   
Address:  Industriepark Zwijnaarde 7 B 9052 Zwijnaarde Belgium
Telephone:
Email: regulatory@argenx.com
Affiliation:  argenx BVBA
Key inclusion & exclusion criteria
Inclusion criteria:
Patients will roll over in this trial only if they meet all of the following criteria:
1. Patients with the ability to understand the requirements of the trial, provide written informed consent, and can 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion criteria:
Patients will not roll over in this trial if they meet any of the following 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 of childbearing potential (DEFINITION OF TERMS) 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 (as mentioned above) 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:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Myasthenia Gravis
MedDRA version: 20.0 Level: PT Classification code 10028417 Term: Myasthenia gravis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: LLT Classification code 10028423 Term: Myasthenia gravis-like syndrome System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: HLT Classification code 10071942 Term: Myasthenia gravis and related conditions System Organ Class: 100000004859
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

Product Name: Efgartigimod
Product Code: ARGX-113
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Efgartigimod
CAS Number: 1821402-21-4
Current Sponsor code: ARGX-113
Other descriptive name: ARGX-113
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Primary end point(s): Incidence and severity of AEs, serious adverse events (SAEs), vital signs,
electrocardiogram (ECG) and laboratory assessments over 1 year in AChR-Ab seropositive patients.
Main Objective: To evaluate the long-term safety and tolerability of ARGX-113 in acetylcholine receptor antibody (AChR-Ab) seropositive patients.
Secondary Objective: To evaluate the long-term safety and tolerability of ARGX-113 in the overall population (AChR-Ab seropositive and AChR-Ab seronegative patients).
Timepoint(s) of evaluation of this end point: Over 1 year
Secondary Outcome(s)

Secondary end point(s): 1) Incidence and severity of AEs, SAEs, vital signs, ECG and laboratory assessments over 1 year in the overall population (AChR-Ab seropositive patients and AChR-Ab
seronegative patients).

2) Incidence and severity of AEs, SAEs, vital signs, ECG and laboratory assessments at each Treatment Period in AChR-Ab seropositive patients.

3) Incidence and severity of AEs, SAEs, vital signs, ECG and laboratory assessments at each Treatment Period in the overall population (AChR-Ab seropositive patients and AChR-Ab seronegative patients).

Timepoint(s) of evaluation of this end point: Sec EP 1: over 1 year
Sec EP 2: after each treatment period
Sec EP 3: after each treatment period
Secondary ID(s)
2018-002133-37-NL
ARGX-113-1705
Source(s) of Monetary Support
argenx BVBA
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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