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

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ClinicalTrials.gov Identifier: NCT03669588
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
argenx BVBA

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Generalized Myasthenia Gravis Biological: ARGX-113 Biological: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ARGX-113 Biological: ARGX-113
Intravenous administration of ARGX-113
Other Name: efgartigimod

Placebo Comparator: Placebo Biological: Placebo
Intravenous administration of placebo




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Duration of response [ Time Frame: Through study completion, an average of 26 weeks ]
  5. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669588


Contacts
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Contact: Antonio Guglietta, MD 3293103471 clinicaltrials@argenx.com

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Sponsors and Collaborators
argenx BVBA
Investigators
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Study Director: Antonio Guglietta, MD argenx BVBA

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Responsible Party: argenx BVBA
ClinicalTrials.gov Identifier: NCT03669588     History of Changes
Other Study ID Numbers: ARGX-113-1704
2018-002132-25 ( EudraCT Number )
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscle Weakness
Paresis
Myasthenia Gravis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases