Fase 2 undersøgelse af sikkerhed og effektivitet af PRA023 i forsøgspersoner med systemisk sklerose forbundet med interstitiel lungesygdom (SSc-ILD) (ATHENA-SSc-ILD)
21. september 2026 opdateret af: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
En dobbeltblind, randomiseret, placebo-kontrolleret undersøgelse til evaluering af effektiviteten og sikkerheden af PRA023 hos forsøgspersoner med systemisk sklerose forbundet med interstitiel lungesygdom (SSc-ILD)
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.
Studieoversigt
Status
Status
Aktiv, ikke rekrutterende
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
Tilmelding
154
Fase
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Buenos Aires
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CABA, Buenos Aires, Argentina, C1426ABP
- Consultorios Médicos Dr. Doreski ( Site 4800)
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Munro, Buenos Aires, Argentina, 1605
- Clínica Privada Independencia ( Site 4802)
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Córdoba Province
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Río Cuarto, Córdoba Province, Argentina, 5800
- Centro de Investigación Instituto Médico Río Cuarto ( Site 4801)
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, S2000CEJ
- Instituto Medico de la Fundacion Estudios Clinicos ( Site 4803)
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South Australia
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Adelaide, South Australia, Australien, 5000
- Royal Adelaide Hospital ( Site 4050)
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Victoria
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Melbourne, Victoria, Australien, 3065
- St Vincents Hospital Melbourne ( Site 4051)
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Belgien, 9000
- UZ Gent ( Site 4401)
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgien, 3000
- UZ Leuven ( Site 4402)
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Wallonne, Region
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Liège, Wallonne, Region, Belgien, 4000
- CHU de Liege ( Site 4400)
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Alberta
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Edmonton, Alberta, Canada, T6G 1W9
- University Of Alberta Hospital ( Site 4702)
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Ontario
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London, Ontario, Canada, N6A 4V2
- St. Joseph's Health Care London ( Site 4701)
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Toronto, Ontario, Canada, M5T 3L9
- Mount Sinai Hospital [Toronto, Canada] ( Site 4700)
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Araucania
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Temuco, Araucania, Chile, 4780000
- Centro de especialidades médicas Vanguardia ( Site 4850)
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chile, 8320000
- BIOCINETIC Ltda ( Site 4854)
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Santiago, Region M. de Santiago, Chile, 8330034
- Centro de Investigacion Clinica UC CICUC ( Site 4855)
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Santiago, Region M. de Santiago, Chile, 8420383
- Centro Internacional de Estudios Clinicos CIEC ( Site 4851)
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Vitacura, Region M. de Santiago, Chile, 7640881
- Clinica Dermacross ( Site 4853)
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Valparaiso
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Viña del Mar, Valparaiso, Chile, 2520598
- ONCOCENTRO APYS ( Site 4852)
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Leeds, Det Forenede Kongerige, LS7 4SA
- Chapel Allerton Hospital ( Site 4551)
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London, City of
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London, London, City of, Det Forenede Kongerige, NW3 2QG
- Royal Free Hospital ( Site 4550)
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Arizona
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Phoenix, Arizona, Forenede Stater, 85054
- Mayo Clinic - Scottsdale ( Site 4014)
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California
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Los Angeles, California, Forenede Stater, 90045
- Pacific Arthritis Care Center ( Site 4008)
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Los Angeles, California, Forenede Stater, 90048
- Cedars Sinai Medical Center ( Site 4010)
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Los Angeles, California, Forenede Stater, 90095-1670
- UCLA School of Medicine ( Site 4006)
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Palo Alto, California, Forenede Stater, 94304
- Stanford Health Care ( Site 4009)
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Colorado
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Denver, Colorado, Forenede Stater, 80206
- National Jewish Health Medical Center ( Site 4015)
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06519
- Yale University ( Site 4017)
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20007
- MedStar Georgetown University Hospital ( Site 4005)
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Maryland
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Baltimore, Maryland, Forenede Stater, 21224
- Johns Hopkins Asthma and Allergy Center [Baltimore, MD] ( Site 4018)
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital ( Site 4003)
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Boston, Massachusetts, Forenede Stater, 02118
- Boston University School of Medicine ( Site 4021)
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan Hospital ( Site 4001)
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New Jersey
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New Brunswick, New Jersey, Forenede Stater, 08901
- Rutgers Robert Wood Johnson Medical School ( Site 4013)
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New York
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New York, New York, Forenede Stater, 10021
- Hospital For Special Surgery ( Site 4020)
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Ohio
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Foundation ( Site 4019)
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Toledo, Ohio, Forenede Stater, 43614
- University of Toledo Medical Center ( Site 4002)
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- University of Pittsburgh Medical Center ( Site 4016)
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina - PPDS ( Site 4004)
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Texas
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Houston, Texas, Forenede Stater, 77030
- UT Physicians Rheumatology ( Site 4007)
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Froedtert and Medical College of Wisconsin ( Site 4012)
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Paris, Frankrig, 75679
- Hopital Cochin ( Site 4203)
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Nord
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Bordeaux, Nord, Frankrig, 33076
- CHU de Bordeaux. Hopital Pellegrin ( Site 4202)
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Lille, Nord, Frankrig, 59000
- Hôpital Claude Huriez ( Site 4200)
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Gelderland
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Nijmegen, Gelderland, Holland, 6500 HB
- Radboud University Medical Center ( Site 4650)
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Haifa, Israel, 3109601
- Rambam Medical Center ( Site 4601)
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Kfar Saba, Israel, 4428164
- Meir Medical Center. ( Site 4604)
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Nahariya, Israel, 2210001
- Galilee Medical Center ( Site 4602)
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Petach Tikvah, Israel, 49100
- Rabin Medical Center ( Site 4603)
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Ramat Gan, Israel, 5265601
- Sheba Medical Center ( Site 4605)
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Tel Aviv, Israel, 6423906
- Tel Aviv Sourasky Medical Center ( Site 4606)
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Florence, Italien, 50141
- Azienda Ospedaliera Universitaria Careggi ( Site 4301)
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Genova, Italien, 16132
- Ospedale Policlinico San Martino ( Site 4305)
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Milan, Italien, 20122
- IRCCS Osp. Maggiore Policlinico ( Site 4306)
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Milan, Italien, 20132
- Ospedale San Raffaele di Milano ( Site 4307)
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Pavia, Italien, 27100
- Fondazione IRCCS Policlinico San Matteo ( Site 4303)
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Reggio Emilia, Italien, 42123
- Arcispedale Santa Maria Nuova ( Site 4300)
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Roma, Italien, 00161
- Azienda Policlinico Umberto I ( Site 4302)
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Piedmont
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Turin, Piedmont, Italien, 10126
- A.O.U. Citta della Salute e della Scienza di Torino ( Site 4304)
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Jalisco
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Guadalajara, Jalisco, Mexico, 44670
- PanAmerican Clinical Research - Guadalajara ( Site 4900)
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Mexico City
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Mexico City, Mexico City, Mexico, 31000
- Centro de Investigación y Tratamiento Reumatológico S.C ( Site 4902)
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Oslo, Norge, 0372
- Oslo Universitetssykehus HF. Rikshospitalet ( Site 4350)
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Lima, Peru, 15023
- Instituto de Ginecologia y Reproduccion ( Site 4952)
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Polen, 61-293
- Twoja Przychodnia Poznanskie Centrum Medyczne ( Site 4452)
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Warszawa, Greater Poland Voivodeship, Polen, 02-637
- Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartanska 1 ( Site
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Kuyavian-Pomeranian Voivodeship
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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polen, 85-168
- Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy ( Site 4454)
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, Polen, 52-416
- Centrum Medyczne Oporow ( Site 4455)
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polen, 02-691
- Centrum Medyczne Reuma Park NZOZ ( Site 4450)
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Polen, 15-276
- Uniwersytecki Szpital Kliniczny w Bialymstoku - Marii Sklodowskiej-Curie 24A ( Site 4451)
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Silesian Voivodeship
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Bytom, Silesian Voivodeship, Polen, 41-902
- Szpital Specjalistyczny nr 1 w Bytomiu ( Site 4453)
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Geneva, Schweiz, 1211
- Hopitaux Universitaires de Geneve HUG ( Site 4503)
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Zurich, Schweiz, 8091
- Universitaetsspital Zuerich ( Site 4500)
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Canton of Bern
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Bern, Canton of Bern, Schweiz, 3010
- Inselspital Bern ( Site 4502)
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Canton of St. Gallen
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Sankt Gallen, Canton of St. Gallen, Schweiz, 9007
- Kantonsspital St. Gallen ( Site 4501)
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Barcelona, Spanien, 08035
- Hospital Universitario Vall d'Hebron - PPDS ( Site 4107)
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Barcelona, Spanien, 08041
- Hospital Santa Creu i Sant Pau ( Site 4102)
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Madrid, Spanien, 28034
- Hospital Universitario Ramon y Cajal ( Site 4101)
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Málaga, Spanien, 29009
- Hospital Regional Universitario de Malaga ( Site 4104)
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Valencia, Spanien, 46017
- Hospital Universitario Doctor Peset ( Site 4103)
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Zaragoza, Spanien, 50009
- Hospital Clinico Universitario Lozano Blesa ( Site 4100)
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Catalonia
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Barcelona, Catalonia, Spanien, 08036
- HOSPITAL CLÍNIC DE BARCELONA ( Site 4105)
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, Spanien, 28041
- Hospital Universitario 12 de Octubre ( Site 4106)
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Principality of Asturias
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Oviedo, Principality of Asturias, Spanien, 33011
- Hospital Central de Asturias ( Site 4109)
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Baden-Wurttemberg
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Freiburg im Breisgau, Baden-Wurttemberg, Tyskland, 79106
- Universitaetsklinikum Freiburg ( Site 4152)
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Hesse
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Bad Nauheim, Hesse, Tyskland, 61231
- Kerckhoff-Klinik-Forschungs-GmbH ( Site 4153)
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Mecklenburg-Vorpommern
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Hohenfelde B Bad Doberan, Mecklenburg-Vorpommern, Tyskland, 18209
- Rheumazentrum am Krankenhaus Bad Doberan ( Site 4150)
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North Rhine-Westphalia
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Cologne, North Rhine-Westphalia, Tyskland, 50937
- Universitaetsklinikum Koeln ( Site 4151)
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Kyiv, Ukraine, 02091
- Medical Center OK!Clinic+LLC International Institute of Clinical Research ( Site 4753)
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Kyiv, Ukraine, 2081
- Institute of Rheumatology LLC ( Site 4752)
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Kyivska Oblast
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Kyiv, Kyivska Oblast, Ukraine, 02125
- Kyiv City Clinical Hospital # 3 ( Site 4754)
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Ternopil Oblast
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Ternopil, Ternopil Oblast, Ukraine, 46002
- ME "Ternopil Regional Clinical Hospital of Ternopil Regional Council" ( Site 4750)
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Vinnytsia Oblast
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Vinnytsia, Vinnytsia Oblast, Ukraine, 21018
- Vinnytsia Nat Med University n.a.M.Pyrogov,City Clinical Hospital #1 ( Site 4751)
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Budapest, Ungarn, 1023
- Budai Irgalmasrendi Korhaz ( Site 4252)
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Budapest, Ungarn, 1097
- Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet ( Site 4253)
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Debrecen, Ungarn, 4032
- Debreceni Egyetem Klinikai Kozpont ( Site 4251)
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Baranya
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Pécs, Baranya, Ungarn, 7632
- Pecsi Tudomanyegyetem AOK ( Site 4250)
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Has confirmed diagnosis of systemic sclerosis with onset of disease ≤ 5 years ago.
- Has diffuse cutaneous scleroderma
- Has systemic sclerosis related interstitial lung disease confirmed by HRCT
- FVC ≥ 45% of predicted normal
- Diffusing capacity of lung for carbon monoxide (DLCO)≥ 45% of predicted normal
- If on background therapy, meets stable dosing requirements for nintedanib, mycophenolate mofetil (MMF), methotrexate (MTX) OR azathioprine, and corticosteroids
- Women of childbearing potential are eligible to participate if not pregnant or breastfeeding and either willing to use an acceptable contraceptive method or sexually abstinent
- Able to provide written informed consent and understand and comply with the requirements of the study
Exclusion Criteria:
- Has an airway obstruction per pulmonary function test (PFT) or clinically significant pulmonary arterial hypertension
- Has current clinical diagnosis of another inflammatory connective tissue disease
- Has any active infections, a serious infection within the past 3 months, or chronic bacterial infection
- Is a current smoker or smoking within 6 months of screening
- Has any concomitant medical conditions that, in the opinion of the investigator, might place them in unacceptable risk for participation in the study
- Meets the protocol criteria for important laboratory exclusion criteria
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Antal våben
2
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Tulisokibart
Tulisokibart IV administered by IV infusion |
Tulisokibart administered at timepoints as directed by the protocol
Andre navne:
CDx+ or CDx- |
|
Placebo komparator: Placebo
Placebo administered by IV infusion |
Placebo CDx+ or CDx- |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants who Experience an Adverse Event (AE)
Tidsramme: Up to Week 50
|
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants who experience an AE will be reported. |
Up to Week 50
|
|
Number of Participants who Experience a Serious Adverse Event (SAE)
Tidsramme: Up to Week 50
|
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants who experience an SAE will be reported. |
Up to Week 50
|
|
Number of Participants who Discontinue due to an AE
Tidsramme: Up to Week 50
|
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants who discontinue due to an AE will be reported. |
Up to Week 50
|
|
Change from Baseline in the Annual Rate of Change in Forced Vital Capacity (FVC) at Week 50
Tidsramme: Baseline and up to Week 50
|
FVC, as measured in milliliters by spirometry, is the amount of air forcibly exhaled from the lungs after taking the deepest breath possible. |
Baseline and up to Week 50
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline in FVC at Week 50
Tidsramme: Baseline and Week 50
|
FVC, as measured in milliliters by spirometry, is the amount of air forcibly exhaled from the lungs after taking the deepest breath possible. |
Baseline and Week 50
|
|
Change from Baseline in High-Resolution Computer Tomography (HRCT) Quantitative Interstitial Lung Disease - Whole Lung (QILD-WL) at Week 50
Tidsramme: Baseline and Week 50
|
QILD-WL will be measured as percent lung involvement using HRCT. |
Baseline and Week 50
|
|
Percentage of Participants with an Improvement in the Revised Composite Response Index in Systemic Sclerosis (CRISS) Score at Week 50
Tidsramme: Baseline and Week 50
|
The Revised CRISS is a two-step process designed to evaluate the likelihood of improvement in early SSc. The first step assesses worsening or incident cases of internal organ involvement (scleroderma renal crisis, pulmonary arterial hypertension, congestive heart failure, ILD, severe gastrointestinal dysmotility requiring parenteral or enteral nutrition, and digital ischemia requiring hospitalization, gangrene, or amputation). The second step assesses changes from baseline in five core set measures: modified Rodnan skin score (mRSS), percent predicted forced vital capacity (FVC%), health assessment questionnaire-disability index (HAQ-DI), patient (PGA), and physician (PhGA) global assessments. |
Baseline and Week 50
|
|
Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 50
Tidsramme: Baseline and Week 50
|
HAQ is an instrument to assess physical function. It consists of 20 questions, covering eight types of activities. For each question, scores range from 0 to 3 (0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty or with assistance; 3 = unable to do). HAQ Disability Index (HAQ-DI) score is the average of the highest score in each of the eight categories. |
Baseline and Week 50
|
|
Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Quality of Life (QoL) Outcome at Week 50
Tidsramme: Baseline and Week 50
|
The L-PF is a questionnaire designed to assess the quality of life of patients with pulmonary fibrosis. It contains 44 questions (items) split into two modules, 23 which assess symptoms (including shortness of breath, cough, and fatigue) and 21 which assess impacts to quality of life. Individual items are scored on a 5-point scale (0 = Not at All to 4 = Extremely). Overall scores range from 0 to 100 with higher scores indicating a greater impairment. |
Baseline and Week 50
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Prometheus Biosciences, Clinical Trials Call Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
29. marts 2022
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
16. april 2026
Studieafslutning (Anslået)
Studieafslutning
16. november 2026
Datoer for studieregistrering
Først indsendt
Først indsendt
27. februar 2022
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
7. marts 2022
Først opslået (Faktiske)
Først opslået
8. marts 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
22. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. september 2026
Sidst verificeret
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 7240-007
- PR200-104 (Anden identifikator: PrometheusBio)
- 2021-005206-10 (EudraCT nummer)
- MK-7240-007 (Anden identifikator: MSD)
- U1111-1309-6150 (Registry Identifier: UTN)
- 2023-509743-27-00 (Registry Identifier: EU CT)
- 2023 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .