A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness. (ADAPT+)

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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225049

Enrollment

150

Registered

2020-02-04

Start date

2019-08-14

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Myasthenia Gravis

Interventions

investigational material(s) Generic name etc : ARGX-113 INN of investigational material : efgartigimod Therapeutic category code : 639 Other biological preparations Dosage and Administration for Inves

dosage: 10mg/kg (capped at 1200 mg) control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material :

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
safety Safety and Tolerability as measured by the incidence of treatment emergent (serious) adverse events in the AChR-positive population.	—

Secondary

Measure	Time frame
safety 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).	—

Countries

Europe, Japan, North America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026