A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.
NCT ID: NCT03770403
Last Updated: 2023-07-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
151 participants
INTERVENTIONAL
2019-03-01
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ARGX-113
ARGX-113
Intravenous administration of ARGX-113
Interventions
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ARGX-113
Intravenous administration of ARGX-113
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients who participated in trial ARGX-113-1704 and are eligible for roll over, as specified in the protocol.
Exclusion Criteria
2. Pregnant and lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing. Women or childbearing potential should have a negative urine pregnancy test at SEB.
3. 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.
4. Patients with known Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) seropositivity.
18 Years
ALL
No
Sponsors
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argenx
INDUSTRY
Responsible Party
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Principal Investigators
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Sabine Coppieters, MD
Role: STUDY_DIRECTOR
argenx
Locations
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Investigator Site 42
Carlsbad, California, United States
Investigator Site 8
Los Angeles, California, United States
Investigator Site 33
Orange, California, United States
Investigator Site 21
Palo Alto, California, United States
Investigator Site 41
Jacksonville, Florida, United States
Investigator Site 4
Tampa, Florida, United States
Investigator Site 14
Kansas City, Kansas, United States
Investigator Site 32
Detroit, Michigan, United States
Investigator Site 2
Chapel Hill, North Carolina, United States
Investigator Site 18
Cleveland, Ohio, United States
Investigator Site 12
Portland, Oregon, United States
Investigator Site 1
Cordova, Tennessee, United States
Investigator Site 3
San Antonio, Texas, United States
Investigator Site 37
Charlottesville, Virginia, United States
Investigator Site 11
Edegem, , Belgium
Investigator Site 7
Ghent, , Belgium
Investigator Site 20
Toronto, Ontario, Canada
Investigator Site 25
Montreal, Quebec, Canada
Investigator Site 16
Brno, , Czechia
Investigator Site 19
Ostrava-Poruba, , Czechia
Investigator Site 30
Prague, , Czechia
Investigator Site 49
Aarhus, , Denmark
Investigator Site 17
Copenhagen, , Denmark
Investigator Site 50
Bordeaux, , France
Investigator Site 51
Marseille, , France
Investigator Site 45
Tbilisi, , Georgia
Investigator Site 31
Tbilisi, , Georgia
Investigator Site 46
Tbilisi, , Georgia
Investigator Site 28
Berlin, , Germany
Investigator Site 35
Budapest, , Hungary
Investigator Site 52
Szeged, , Hungary
Investigator Site 10
Milan, MI, Italy
Investigator Site 5
Napoli, , Italy
Investigator Site 38
Roma, , Italy
Investigator Site 24
Sapporo, Hokkaido, Japan
Investigator Site 13
Hanamaki-shi, Iwate, Japan
Investigator Site 27
Sendai, Miyagi, Japan
Investigator Site 23
Ōsaka-sayama, Osaka, Japan
Investigator Site 22
Suita, Osaka, Japan
Investigator Site 40
Meguro City, Tokyo, Japan
Investigator Site 43
Shinjuku-Ku, Tokyo, Japan
Investigator Site 47
Chiba, , Japan
Investigator Site 44
Hiroshima, , Japan
Investigator Site 48
Minato, , Japan
Investigator Site 36
Leiden, , Netherlands
Investigator Site 9
Gdansk, , Poland
Investigator Site 29
Katowice, , Poland
Investigator Site 6
Krakow, , Poland
Investigator Site 15
Warsaw, , Poland
Investigator Site 34
Novosibirsk, , Russia
Investigator Site 39
Samara, , Russia
Investigator Site 26
Belgrade, , Serbia
Countries
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References
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Howard JF Jr, Bril V, Vu T, Karam C, Peric S, De Bleecker JL, Murai H, Meisel A, Beydoun SR, Pasnoor M, Guglietta A, Van Hoorick B, Steeland S, T'joen C, Utsugisawa K, Verschuuren J, Mantegazza R; ADAPT+ Study Group. Long-term safety, tolerability, and efficacy of efgartigimod (ADAPT+): interim results from a phase 3 open-label extension study in participants with generalized myasthenia gravis. Front Neurol. 2024 Jan 17;14:1284444. doi: 10.3389/fneur.2023.1284444. eCollection 2023.
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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2018-002133-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ARGX-113-1705
Identifier Type: -
Identifier Source: org_study_id
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