An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness (ADAPT)

argenx

Status and phase: Completed; Phase 3

Conditions: Generalized Myasthenia Gravis

Treatments: Biological: Placebo; Biological: ARGX-113

Study type: Interventional

Funder types: Industry

Identifiers

NCT03669588

2018-002132-25 (EudraCT Number)

ARGX-113-1704

Details and patient eligibility

About

A randomized, double-blind, placebo controlled, multicenter Phase 3 trial to evaluate the efficacy, safety, tolerability, quality of life and impact on normal daily activities of ARGX-113 in patients with gMG.

Enrollment: 167 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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167 participants in 2 patient groups, including a placebo group

ARGX-113

Experimental group

Treatment:

Biological: ARGX-113

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo