An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness
NCT ID: NCT03669588
Last Updated: 2022-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
167 participants
INTERVENTIONAL
2018-08-22
2020-04-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ARGX-113
ARGX-113
Intravenous administration of ARGX-113
Placebo
Placebo
Intravenous administration of placebo
Interventions
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ARGX-113
Intravenous administration of ARGX-113
Placebo
Intravenous administration of placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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)
18 Years
ALL
No
Sponsors
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argenx
INDUSTRY
Responsible Party
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Principal Investigators
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Antonio Guglietta, MD
Role: STUDY_DIRECTOR
argenx
Locations
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Investigator Site 29
Phoenix, Arizona, United States
Investigator Site 66
Carlsbad, California, United States
Investigator Site 5
Los Angeles, California, United States
Investigator Site 49
Los Angeles, California, United States
Investigator Site 18
Orange, California, United States
Investigator Site 40
Palo Alto, California, United States
Investigator Site 59
San Francisco, California, United States
Investigator Site 58
Aurora, Colorado, United States
Investigator Site 34
Jacksonville, Florida, United States
Investigator Site 4
Tampa, Florida, United States
Investigator Site 30
Springfield, Illinois, United States
Investigator Site 25
Iowa City, Iowa, United States
Investigator Site 21
Kansas City, Kansas, United States
Investigator Site 27
Boston, Massachusetts, United States
Investigator Site 48
Detroit, Michigan, United States
Investigator Site 53
Buffalo, New York, United States
Investigator Site 3
Chapel Hill, North Carolina, United States
Investigator Site 20
Cleveland, Ohio, United States
Investigator Site 9
Portland, Oregon, United States
Investigator Site 17
Charleston, South Carolina, United States
Investigator Site
Cordova, Tennessee, United States
Investigator Site 44
Houston, Texas, United States
Investigator Site 6
San Antonio, Texas, United States
Investigator Site 2
Charlottesville, Virginia, United States
Investigator Site 16
Seattle, Washington, United States
Investigator Site 11
Edegem, , Belgium
Investigator Site 8
Ghent, , Belgium
Investigator Site 38
Edmonton, Alberta, Canada
Investigator Site 24
Toronto, Ontario, Canada
Investigator Site 22
Montreal, Quebec, Canada
Investigator Site 32
Brno, , Czechia
Investigator Site 35
Ostrava-Poruba, , Czechia
Investigator Site 51
Prague, , Czechia
Investigator Site 36
Aarhus, , Denmark
Investigator Site 15
Copenhagen, , Denmark
Investigator Site 13
Bordeaux, , France
Investigator Site 52
Marseille, , France
Investigator Site 46
Tbilisi, , Georgia
Investigator Site 45
Tbilisi, , Georgia
Investigator Site 47
Tbilisi, , Georgia
Investigator Site 33
Berlin, , Germany
Investigator Site 55
Budapest, , Hungary
Investigator Site 54
Szeged, , Hungary
Investigator Site 10
Milan, , Italy
Investigator Site 12
Napoli, , Italy
Investigator Site 42
Chiba, Chiba, Japan
Investigator Site 26
Sapporo, Hokkaido, Japan
Investigator Site 19
Hanamaki, Iwate, Japan
Investigator Site 43
Sendai, Miyagi, Japan
Investigator Site 28
Ōsaka-sayama, Osaka, Japan
Investigator Site 50
Suita, Osaka, Japan
Investigator Site 31
Meguro City, Tokyo, Japan
Investigator Site 41
Minato-Ku, Tokyo, Japan
Investigator Site 39
Shinjuku-Ku, Tokyo, Japan
Investigator Site 37
Leiden, , Netherlands
Investigator Site 7
Gdansk, , Poland
Investigator Site 57
Katowice, , Poland
Investigator Site 14
Krakow, , Poland
Investigator Site 23
Warsaw, , Poland
Investigator Site 64
Krasnoyarsk, , Russia
Investigator Site 62
Nizhny Novgorod, , Russia
Investigator Site 65
Novosibirsk, , Russia
Investigator Site 60
Samara, , Russia
Investigator Site 61
Belgrade, , Serbia
Investigator Site 63
Edgbaston, , United Kingdom
Investigator Site 56
Liverpool, , United Kingdom
Countries
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References
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Janssen MF, Dewilde S, Wolfe GI, Muppidi S, Phillips G. Psychometric properties of MG-ADL items and MG-ADL score: An assessment of distributional characteristics, validity and factor structure in two large datasets. J Neurol Sci. 2024 Aug 15;463:123135. doi: 10.1016/j.jns.2024.123135. Epub 2024 Jul 22.
Howard JF Jr, Bril V, Vu T, Karam C, Peric S, Margania T, Murai H, Bilinska M, Shakarishvili R, Smilowski M, Guglietta A, Ulrichts P, Vangeneugden T, Utsugisawa K, Verschuuren J, Mantegazza R; ADAPT Investigator Study Group. Safety, efficacy, and tolerability of efgartigimod in patients with generalised myasthenia gravis (ADAPT): a multicentre, randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2021 Jul;20(7):526-536. doi: 10.1016/S1474-4422(21)00159-9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-002132-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ARGX-113-1704
Identifier Type: -
Identifier Source: org_study_id
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