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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 : October 2, 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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Locations
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United States, Arizona
Investigator Site 29 Recruiting
Phoenix, Arizona, United States, 85018
Contact: Antonio Guglietta, MD    329-310-3471    clinicaltrials@argenx.com   
United States, California
Investigator Site 66 Not yet recruiting
Carlsbad, California, United States, 92011
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Investigator Site 5 Recruiting
Los Angeles, California, United States, 90033
Contact: Antonio Guglietta, MD    329-310-3471    clinicaltrials@argenx.com   
Investigator Site 49 Recruiting
Los Angeles, California, United States, 90095
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Investigator Site 18 Recruiting
Orange, California, United States, 92868
Contact: Antonio Guglietta, MD    329-310-3471    clinicaltrials@argenx.com   
Investigator Site 40 Recruiting
Palo Alto, California, United States, 94304
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Investigator Site 59 Recruiting
San Francisco, California, United States, 94115
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
United States, Colorado
Investigator Site 58 Recruiting
Aurora, Colorado, United States, 80045
Contact: Antonio Gugliett, MD    329-310-3471    Clinicaltrials@argenx.com   
United States, Florida
Investigator Site 34 Recruiting
Jacksonville, Florida, United States, 32209
Contact: Antonio Guglietta, MD    329-310-3471    clinicaltrials@argenx.com   
Investigator Site 4 Recruiting
Tampa, Florida, United States, 33612
Contact: Antonio Guglietta, MD    329-310-3471    clinicaltrials@argenx.com   
United States, Illinois
Investigator Site 30 Recruiting
Springfield, Illinois, United States, 62702
Contact: Antonio Guglietta, MD    329-310-3471    clinicaltrials@argenx.com   
United States, Iowa
Investigator Site 25 Recruiting
Iowa City, Iowa, United States, 52242
Contact: Antonio Guglietta, MD    329-310-3471    clinicaltrials@argenx.com   
United States, Kansas
Investigator Site 21 Recruiting
Kansas City, Kansas, United States, 66160
Contact: Antonio Guglietta, MD    329-310-3471    clinicaltrials@argenx.com   
United States, Massachusetts
Investigator Site 27 Recruiting
Boston, Massachusetts, United States, 02115
Contact: Antonio Guglietta, MD    329-310-3471    clinicaltrials@argenx.com   
United States, Michigan
Investigator Site 48 Recruiting
Detroit, Michigan, United States, 48201
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
United States, New York
Investigator Site 53 Active, not recruiting
Buffalo, New York, United States, 14202
United States, North Carolina
Investigator Site 3 Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Antonio Guglietta, MD    329-310-3471    clinicaltrials@argenx.com   
United States, Ohio
Investigator Site 20 Recruiting
Cleveland, Ohio, United States, 44195
Contact: Antonio Guglietta, MD    329-310-3471    clinicaltrials@argenx.com   
United States, Oregon
Investigator Site 9 Recruiting
Portland, Oregon, United States, 97239
Contact: Antonio Guglietta, MD    329-310-3471    clinicaltrials@argenx.com   
United States, South Carolina
Investigator Site 17 Recruiting
Charleston, South Carolina, United States, 29425
Contact: Antonio Guglietta, MD    329-310-3471    clinicaltrials@argenx.com   
United States, Tennessee
Investigator Site Recruiting
Cordova, Tennessee, United States, 38018
Contact: Antonio Guglietta, MD    329-310-3471    clinicaltrials@argenx.com   
United States, Texas
Investigator Site 44 Recruiting
Houston, Texas, United States, 77030
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Investigator Site 6 Recruiting
San Antonio, Texas, United States, 78229
Contact: Antonio Guglietta, MD    329-310-3471    clinicaltrials@argenx.com   
United States, Virginia
Investigator Site 2 Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Antonio Guglietta, MD    329-310-3471    clinicaltrials@argenx.com   
United States, Washington
Investigator Site 16 Recruiting
Seattle, Washington, United States, 98195
Contact: Antonio Guglietta, MD    329-310-3471    clinicaltrials@argenx.com   
Belgium
Investigator Site 11 Recruiting
Edegem, Belgium, 2650
Contact: Antonio Guglietta, MD    3293103471    clinicaltrials@argenx.com   
Investigator Site 8 Recruiting
Ghent, Belgium, 9000
Contact: Antonio Guglietta, MD    3293103471    clinicaltrials@argenx.com   
Canada, Alberta
Investigator Site 38 Recruiting
Edmonton, Alberta, Canada, T6G 2G3
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Canada, Ontario
Investigator Site 24 Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Antonio Guglietta, MD    3293103471    clinicaltrials@argenx.com   
Canada, Quebec
Investigator Site 22 Recruiting
Montréal, Quebec, Canada, H3A 2B4
Contact: Antonio Guglietta, MD    3293103471    clinicaltrials@argenx.com   
Czechia
Investigator Site 32 Recruiting
Brno, Czechia, 62500
Contact: Antonio Guglietta, MD    329-310-3471    clinicaltrials@argenx.com   
Investigator Site 35 Recruiting
Ostrava-Poruba, Czechia, 70852
Contact: Antonio Guglietta, MD    329-310-3471    clinicaltrials@argenx.com   
Investigator Site 51 Recruiting
Praha 2, Czechia, 128 00
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Denmark
Investigator Site 36 Recruiting
Aarhus, Denmark, 8200
Contact: Antonio Guglietta, MD    329-310-3471    clinicaltrials@argenx.com   
Investigator Site 15 Recruiting
Copenhagen, Denmark, 2100
Contact: Antonio Guglietta, MD    3293103471    clinicaltrials@argenx.com   
France
Investigator Site 13 Recruiting
Bordeaux Cedex, France, 33076
Contact: Antonio Guglietta, MD    3293103471    clinicaltrials@argenx.com   
Investigator Site 52 Active, not recruiting
Marseille, France, 13385
Georgia
Investigator Site 46 Recruiting
Tbilisi, Georgia, 0112
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Investigator Site 45 Recruiting
Tbilisi, Georgia, 0114
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Investigator Site 47 Recruiting
Tbilisi, Georgia, 0114
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Germany
Investigator Site 33 Recruiting
Berlin, Germany, 10117
Contact: Antonio Guglietta, MD    329-310-3471    clinicaltrials@argenx.com   
Hungary
Investigator Site 55 Recruiting
Budapest, Hungary, 1204
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Investigator Site 54 Recruiting
Szeged, Hungary, 6725
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Italy
Investigator Site 10 Recruiting
Milano, Italy, 20133
Contact: Antonio Guglietta, MD    3293103471    clinicaltrials@argenx.com   
Investigator Site 12 Recruiting
Napoli, Italy, 80131
Contact: Antonio Guglietta, MD    3293103471    clinicaltrials@argenx.com   
Japan
Investigator Site 42 Recruiting
Chiba-shi, Chiba, Japan, 260-8677
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Investigator Site 26 Recruiting
Sapporo, Hokkaido, Japan, 0608543
Contact: Antonio Guglietta, MD    329-310-3471    clinicaltrials@argenx.com   
Investigator Site 19 Recruiting
Hanamaki, Iwate, Japan, 025-0075
Contact: Antonio Guglietta, MD    3293103471    clinicaltrials@argenx.com   
Investigator Site 43 Recruiting
Sendai, Miyagi, Japan, 983-8520
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Investigator Site 50 Recruiting
Suita, Osaka, Japan, 565-0871
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Investigator Site 28 Recruiting
Ōsaka-sayama, Osaka, Japan, 5898511
Contact: Antonio Guglietta, MD    329-310-3471    clinicaltrials@argenx.com   
Investigator Site 31 Recruiting
Meguro, Tokyo, Japan, 1538515
Contact: Antonio Guglietta, MD    329-310-3471    clinicaltrials@argenx.com   
Investigator Site 41 Recruiting
Minato-Ku, Tokyo, Japan, 108-8329
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Investigator Site 39 Recruiting
Shinjuku-Ku, Tokyo, Japan, 160-0023
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Netherlands
Investigator Site 37 Recruiting
Leiden, Netherlands, 2333 ZA
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Poland
Investigator Site 7 Recruiting
Gdańsk, Poland, 80-952
Contact: Antonio Guglietta, MD    3293103471    clinicaltrials@argenx.com   
Investigator Site 57 Recruiting
Katowice, Poland, 40-123
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Investigator Site 14 Recruiting
Kraków, Poland, 31-505
Contact: Antonio Guglietta, MD    3293103471    Clinicaltrials@argenx.com   
Investigator Site 23 Recruiting
Warszawa, Poland, 02-097
Contact: Antonio Guglietta, MD    3293103471    clinicaltrials@argenx.com   
Russian Federation
Investigator Site 64 Recruiting
Krasnoyarsk, Russian Federation, 660037
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Investigator Site 62 Not yet recruiting
Nizhny Novgorod, Russian Federation, 603126
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Investigator Site 65 Recruiting
Novosibirsk, Russian Federation, 630087
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Investigator Site 60 Recruiting
Samara, Russian Federation, 443095
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Serbia
Investigator Site 61 Recruiting
Belgrade, Serbia, 11000
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
United Kingdom
Investigator Site 63 Recruiting
Edgbaston, United Kingdom, B15 2TH
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
Investigator Site 56 Not yet recruiting
Liverpool, United Kingdom, L9 7LJ
Contact: Antonio Guglietta, MD    329-310-3471    Clinicaltrials@argenx.com   
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: October 2, 2019
Last Verified: September 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
Myasthenia Gravis
Paresis
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