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



Status:Recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:September 5, 2018
End Date:November 2020
Contact:Antonio Guglietta, MD
Email:clinicaltrials@argenx.com
Phone:3293103411

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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

This is 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.


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.
We found this trial at
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Cordova, Tennessee
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Chapel Hill, North Carolina
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Charleston, South Carolina 29412
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Charlottesville, Virginia
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Cleveland, Ohio
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Edegem,
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Iowa City, Iowa 52242
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Los Angeles, California
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Orange, California 92868
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San Antonio, Texas 78224
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Seattle, Washington 98105
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Tampa, Florida
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