A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)
NCT ID: NCT04598477
Last Updated: 2025-03-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
183 participants
INTERVENTIONAL
2021-07-15
2024-03-25
Brief Summary
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Trial ARGX-113-1905 evaluated the ability to (further) taper prednisone therapy and achieve Clinical Remission (CR) off therapy (CRoff), the ability to achieve CR and CR on minimal therapy (CRmin) for participants who had not yet achieved CR or CRmin, and the ability to treat flare; it also assessed patient outcome measures and the safety, PD, PK and immunogenicity of efgartigimod PH20 SC over the duration of trial.
Study duration: Up to 60 weeks for participants who receive IMP administration up to 52 weeks and with a follow-up period of 8 weeks after the last IMP administration
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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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efgartigimod PH20 SC
patients receiving efgartigimod PH20 SC on top of prednisone
efgartigimod PH20 SC
Subcutaneous injection of efgartigimod using rHuPH20 (PH20) as a permeation enhancer
prednisone
Oral prednisone tablets
Interventions
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efgartigimod PH20 SC
Subcutaneous injection of efgartigimod using rHuPH20 (PH20) as a permeation enhancer
prednisone
Oral prednisone tablets
Eligibility Criteria
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Inclusion Criteria
2. The participant participated in trial ARGX-113-1904 and completed the study or has the defined criteria for rollover.
3. Contraceptive use by men and women should be consistent with local regulations regarding the methods for contraception for those participating in clinical trials and:
1. Male participants:
Male participants must agree to use an acceptable method of contraception as described in the protocol, from signing the ICF until the last dose of the study drug.
2. Female participants
Women of childbearing potential (WOCBP) must:
* have a negative urine pregnancy test at baseline before the IMP can be administered,
* agree to use a highly effective or acceptable contraception method (as described in the protocol), which should be maintained at minimum until after the last dose of IMP
Exclusion Criteria
2. Participants with clinical evidence of other significant serious disease or participants who recently underwent or have planned a major surgery during the period of the trial, or any other condition in the opinion of the investigator, that could confound the results of the trial or put the participant at undue risk.
3. Known hypersensitivity to any of the components of the administered treatments.
18 Years
ALL
No
Sponsors
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argenx
INDUSTRY
Responsible Party
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Locations
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Investigator site 115 - US0010086
Birmingham, Alabama, United States
Investigator site 89 - US0010091
Scottsdale, Arizona, United States
Investigator site 124 - US0010092
Redwood City, California, United States
Investigator site 1 - US0010087
Boca Raton, Florida, United States
Investigator site 90 - US0010117
Miami, Florida, United States
Investigator site 91 - US0010109
Orlando, Florida, United States
Investigator site 126 - US0010090
Minneapolis, Minnesota, United States
Investigator site 111 - US0010098
St Louis, Missouri, United States
Investigator site 10 - US0010088
Buffalo, New York, United States
Investigator site 76 - US0010096
Durham, North Carolina, United States
Investigator site 30 - US0010094
Cleveland, Ohio, United States
Investigator site 84 - US0010089
Philadelphia, Pennsylvania, United States
Investigator site 103 - US0010097
Philadelphia, Pennsylvania, United States
Investigator site 125 - US0010107
Dallas, Texas, United States
Investigator site 87 - US0010084
Dripping Springs, Texas, United States
Investigator site 88 - US0010114
Houston, Texas, United States
Investigator site 44 - US0010106
Norfolk, Virginia, United States
Investigator site 15 - AU0610006
Sydney, New South Wales, Australia
Investigator site 11 - AU0610007
Parkville, Victoria, Australia
Investigator site 92 - AU0610013
Melbourne, , Australia
Investigator site 17 - BG3590012
Pleven, , Bulgaria
Investigator site 18 - BG3590013
Plovdiv, , Bulgaria
Investigator site 2 - BG3590010
Sofia, , Bulgaria
Investigator site 16 - BG3590009
Sofia, , Bulgaria
Investigator site 3 - BG3590011
Sofia, , Bulgaria
Investigator site 101 - CN0860017
Beijing, , China
Investigator site 107 - CN0860018
Chengdu, , China
Investigator site 118 - CH0860027
Chongqing, , China
Investigator site 120 - CH0860023
Fuzhou, , China
Investigator site 119 - CH0860022
Guangzhou, , China
Investigator site 116 - CH0860053
Guangzhou, , China
Investigator site 100 - CN0860021
Guanzhou, , China
Investigator site 113 - CN0860024
Nanjing, , China
Investigator site 102 - CN0860020
Shanghai, , China
Investigator site 99 - CN0860016
Shanghai, , China
Investigator site 112 - CN0860019
Wuhan, , China
Investigator site 121 - CH0860025
Wuhan, , China
Investigator site 117 - CH0860026
Zhengzhou, , China
Investigator site 77 - FR0330028
Bobigny, , France
Investigator site 60 - FR0330027
La Tronche, , France
Investigator site 108 - FR0330029
Rouen, , France
Investigator site 51 - FR0330026
Saint-Etienne, , France
Investigator site 78 - GE9950014
Tbilisi, , Georgia
Investigator site 127 - GE9950030
Tbilisi, , Georgia
Investigator site 32 - GE9950013
Tbilisi, , Georgia
Investigator site 31 - GE9950015
Tbilisi, , Georgia
Investigator site 45 - DE0490029
Berlin, , Germany
Investigator site 34 - DE0490030
Dresden, , Germany
Investigator site 33 - DE0490024
Frankfurt am Main, , Germany
Investigator site 53 - DE0490023
Freiburg im Breisgau, , Germany
Investigator site 35 - DE0490028
Kiel, , Germany
Investigator site 20 - DE0490002
Lübeck, , Germany
Investigator site 52 - DE0490001
Marburg, , Germany
Investigator site 19 - DE0490025
Tübingen, , Germany
Investigator site 93 - DE0490027
Ulm, , Germany
Investigator site 4 - DE0490026
Würzburg, , Germany
Investigator site 21 - GR030004
Athens, , Greece
Investigator site 37 - GR030006
Athens, , Greece
Investigator site 54 - GR0300001
Athens, , Greece
Investigator site 22 - GR030003
Chaïdári, , Greece
Investigator site 36 - GR0300002
Thessaloniki, , Greece
Investigator site 23 - GR030005
Thessaloniki, , Greece
Investigator site 6 - HU0360003
Debrecen, , Hungary
Investigator site 5 - HU0360001
Pécs, , Hungary
Investigator site 24 - HU0360002
Szeged, , Hungary
Investigator site 65 - IN0910002
Ahmedabad, , India
Investigator site 94 - IN0910001
Chandigarh, , India
Investigator site 79 - IN0910004
Lucknow, , India
Investigator site 80 - IN0910003
Nagpur, , India
Investigator site 85 - IL9720002
Tel Aviv, , Israel
Investigator site 95 - IT0390039
Catania, , Italy
Investigator site 38 - IT0390031
Florence, , Italy
Investigator site 81 - IT0390030
Genova, , Italy
Investigator site 55 - IT0390038
Perugia, , Italy
Investigator site 12 - IT0390006
Roma, , Italy
Investigator site 25 - IT-0390005
Roma, , Italy
Investigator site 61 - IT0390040
Siena, , Italy
Investigator site 82 - JP0810046
Aichi, , Japan
Investigator site 68 - JP0810040
Hiroshima, , Japan
Investigator site 66 - JP0810042
Kofu, , Japan
Investigator site 69 - JP0810050
Kurume, , Japan
Investigator site 73 - JP0810047
Okayama, , Japan
Investigator site 70 - JP0810041
Okayama, , Japan
Investigator site 71 - JP0810049
Osaka, , Japan
Investigator site 72 - JP0810045
Sapporo, , Japan
Investigator site 114 - JP0810067
Sendai, , Japan
Investigator site 67 - JP0810043
Tokyo, , Japan
Investigator site 27 - PL0480027
Katowice, , Poland
Investigator site 56 - PL0480032
Lodz, , Poland
Investigator site 86 - PL0480036
Poznan, , Poland
Investigator site 28 - PL0480025
Rzeszów, , Poland
Investigator site 26 - PL0480028
Wroclaw, , Poland
Investigator site 97 - RO0400013
Bucharest, , Romania
Investigator 96 - RO0400014
Cluj-Napoca, , Romania
Investigator site 98 - RO0400015
Iași, , Romania
Investigator site 40 - RU0070035
Chelyabinsk, , Russia
Investigator site 48 - RU0070029
Kazan', , Russia
Investigator site 49 - RU0070030
Krasnodar, , Russia
Investigator site 39 - RU0070032
Rostov-on-Don, , Russia
Investigator site 46 - RU0070031
Saint Petersburg, , Russia
Investigator site 50 - RU0070034
Saint Petersburg, , Russia
Investigator site 47 - RU0070028
Saratov, , Russia
Investigator site 41 - RU0070033
Yekaterinburg, , Russia
Investigator site 109 - RS3810011
Belgrade, , Serbia
Investigator site 110 - RS3810010
Belgrade, , Serbia
Investigator site 105 - RS3810012
Niš, , Serbia
Investigator site 104 - RS3810009
Novi Sad, , Serbia
Investigator site 62 - ES0340026
Barcelona, , Spain
Investigator site 13 - ES0340032
Barcelona, , Spain
Investigator site 122 - ES0340053
Granada, , Spain
Investigator site 59 - ES0340034
Madrid, , Spain
Investigator site 42 - ES0340025
Madrid, , Spain
Investigator site 7 - ES0340029
Madrid, , Spain
Investigator site 57 - ES0340027
Madrid, , Spain
Investigator site 58 - ES0340028
Seville, , Spain
Investigator site 64 - TR0900020
Gaziantep, , Turkey (Türkiye)
Investigator site 63 - TR0900012
Istanbul, , Turkey (Türkiye)
Investigator site 74 - TR0900011
Istanbul, , Turkey (Türkiye)
Investigator site 75 - UA3800017
Dnipro, , Ukraine
Investigator site 29 - UA3800023
Ivano-Frankivsk, , Ukraine
Investigator site 14 - UA3800020
Kyiv, , Ukraine
Investigator site 8 - UA3800019
Kyiv, , Ukraine
Investigator site 43 - UA3800021
Lviv, , Ukraine
Investigator site 9 - UA3800018
Zaporizhzhia, , Ukraine
Investigator site 106 - UK0440021
Birmingham, , United Kingdom
Investigator site 83 - UK0440022
Bristol, , United Kingdom
Investigator site 123 - UK0440037
Southampton, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ARGX-113-1905
Identifier Type: -
Identifier Source: org_study_id
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