An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.

Phase 1

• Conditions: MedDRA version: 21.1Level: LLTClassification code 10028423Term: Myasthenia gravis-like syndromeSystem Organ Class: 10029205 - Nervous system disorders; Myasthenia Gravis; MedDRA version: 21.1Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]; MedDRA version: 20.0Level: HLTClassification code 10071942Term: Myasthenia gravis and related conditionsSystem Organ Class: 100000004859

• Registration Number: EUCTR2018-002132-25-CZ
• Lead Sponsor: argenx BVBA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-01
• Last Update Posted: 29 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified