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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: 12 December 2020
Main ID:  NCT03669588
Date of registration: 06/09/2018
Prospective Registration: Yes
Primary sponsor: argenx
Public title: An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness ADAPT
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: September 5, 2018
Target sample size: 167
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03669588
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
Belgium Canada Czechia Denmark France Georgia Germany Hungary
Italy Japan Netherlands Poland Russian Federation Serbia United Kingdom 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. 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 defined in the protocol

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 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:

- Hepatitis B Virus (HBV) (except patients who are seropositive because of HBV
vaccination)

- Hepatitis C Virus (HCV)

- Human Immunodeficiency Virus (HIV)

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
Biological: Placebo
Primary Outcome(s)
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 [Time Frame: Week 8]
Secondary Outcome(s)
Duration of response [Time Frame: Through study completion, an average of 26 weeks]
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). [Time Frame: Week 8]
Efficacy of ARGX-113 as assessed by the percentage of "Quantitative Myasthenia Gravis (QMG) responders" in the AChR-Ab seropositive population. [Time Frame: Week 8]
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 [Time Frame: Through study completion, an average of 26 weeks]
Onset of efficacy of ARGX-113 as assessed by the percentage of "early MG-ADL responders" in the AChR-Ab seropositive population. [Time Frame: Up to Week 8]
Secondary ID(s)
2018-002132-25
ARGX-113-1704
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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