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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: 29 June 2020
Main ID:  EUCTR2018-002132-25-CZ
Date of registration: 01/11/2018
Prospective Registration: Yes
Primary sponsor: argenx BVBA
Public title: An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.
Scientific title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness
Date of first enrolment: 25/02/2019
Target sample size: 150
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-002132-25
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
 
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 Georgia Germany Hungary
Italy Japan Netherlands Poland Russian Federation Serbia 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:
1. Patients with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.
2. Male or female patients aged = 18 years.
3. Diagnosis of MG with generalized muscle weakness meeting the clinical criteria for diagnosis of MG as defined by the Myasthenia Gravis Foundation of America (MGFA) class II, III, IVa and IVb.

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:
1.Pregnant and lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing.
2. 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.
3. MGFA Class I and V patients
4. Patients with worsening muscle weakness secondary to concurrent infections or medications.
5.Patients with known seropositivity or who test positive for an active viral infection at Screening with: o Hepatitis B Virus (HBV) (except patients who are seropositive because of HBV vaccination) o Hepatitis C Virus (HCV) o Human Immunodeficiency Virus (HIV)

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: 21.1 Level: PT Classification code 10028417 Term: Myasthenia gravis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1 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-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)
Main Objective: Efficacy of ARGX-113 as assessed by the percentage of “Myasthenia Gravis Activities of Daily Living (MG-ADL) responders” in the acetylcholine receptor (AChR)- antibody (Ab) seropositive population.
Primary end point(s): Efficacy of ARGX-113 as assessed by the percentage of “Myasthenia Gravis Activities of Daily Living (MG-ADL) responders” (acetylcholine receptor (AChR)- antibody (Ab) seropositive population)
Secondary Objective: 1. Efficacy of ARGX-113 as assessed by the percentage of “QMG responders” in the AChR-Ab seropositive population.
2. Efficacy of ARGX-113 as assessed by the percentage of “MG-ADL responders” in the overall population (AChR-Ab seropositive and AChR-Ab seronegative patients).
3. Efficacy of ARGX-113 as assessed by the percentage of time that patients show a “clinically meaningful improvement” in total MG-ADL score during the trial in the AChR-Ab seropositive population.
4. Duration of response
5. Onset of efficacy of ARGX-113 as assessed by the percentage of “early MG-ADL responders” in the AChR-Ab seropositive population.
6. Safety and tolerability of ARGX-113 in the overall population and in subgroups.
Timepoint(s) of evaluation of this end point: Week 8
Secondary Outcome(s)
Secondary end point(s): 1. Efficacy of ARGX-113 as assessed by the percentage of “QMG responders” in the AChR-Ab seropositive population.
2. Efficacy of ARGX-113 as assessed by the percentage of “MG-ADL responders” in the overall population (AChR-Ab seropositive and AChR-Ab seronegative patients).
3. Efficacy of ARGX-113 as assessed by the percentage of time that patients show a “clinically meaningful improvement” in total MG-ADL score during the trial in the AChR-Ab seropositive population.
4. Duration of response
5. Onset of efficacy of ARGX-113 as assessed by the percentage of “early MG-ADL responders” in the AChR-Ab seropositive population.
Timepoint(s) of evaluation of this end point: Sec EP 1: Week 8
Sec EP 2: Week 8
Sec EP 3: Duration of the trial
Sec EP 4: Duration of the trial
Sec EP 5: Week 8
Secondary ID(s)
2018-002132-25-NL
ARGX-113-1704
Source(s) of Monetary Support
argenx BVBA
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 09/01/2019
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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