Fase 2 sikkerhet og effektivitetsstudie av PRA023 hos personer med systemisk sklerose assosiert med interstitiell lungesykdom (SSc-ILD) (ATHENA-SSc-ILD)
21. september 2026 oppdatert av: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
En dobbeltblind, randomisert, placebokontrollert studie for å evaluere effektiviteten og sikkerheten til PRA023 hos personer med systemisk sklerose assosiert med interstitiell lungesykdom (SSc-ILD)
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
154
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
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, Australia, 5000
- Royal Adelaide Hospital ( Site 4050)
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Victoria
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Melbourne, Victoria, Australia, 3065
- St Vincents Hospital Melbourne ( Site 4051)
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Belgia, 9000
- UZ Gent ( Site 4401)
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgia, 3000
- UZ Leuven ( Site 4402)
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Wallonne, Region
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Liège, Wallonne, Region, Belgia, 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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Arizona
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Phoenix, Arizona, Forente stater, 85054
- Mayo Clinic - Scottsdale ( Site 4014)
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California
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Los Angeles, California, Forente stater, 90045
- Pacific Arthritis Care Center ( Site 4008)
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Los Angeles, California, Forente stater, 90048
- Cedars Sinai Medical Center ( Site 4010)
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Los Angeles, California, Forente stater, 90095-1670
- UCLA School of Medicine ( Site 4006)
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Palo Alto, California, Forente stater, 94304
- Stanford Health Care ( Site 4009)
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Colorado
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Denver, Colorado, Forente stater, 80206
- National Jewish Health Medical Center ( Site 4015)
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Connecticut
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New Haven, Connecticut, Forente stater, 06519
- Yale University ( Site 4017)
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20007
- MedStar Georgetown University Hospital ( Site 4005)
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Maryland
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Baltimore, Maryland, Forente stater, 21224
- Johns Hopkins Asthma and Allergy Center [Baltimore, MD] ( Site 4018)
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Massachusetts General Hospital ( Site 4003)
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Boston, Massachusetts, Forente stater, 02118
- Boston University School of Medicine ( Site 4021)
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109
- University of Michigan Hospital ( Site 4001)
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New Jersey
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New Brunswick, New Jersey, Forente stater, 08901
- Rutgers Robert Wood Johnson Medical School ( Site 4013)
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New York
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New York, New York, Forente stater, 10021
- Hospital For Special Surgery ( Site 4020)
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Ohio
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Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic Foundation ( Site 4019)
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Toledo, Ohio, Forente stater, 43614
- University of Toledo Medical Center ( Site 4002)
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15213
- University of Pittsburgh Medical Center ( Site 4016)
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South Carolina
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Charleston, South Carolina, Forente stater, 29425
- Medical University of South Carolina - PPDS ( Site 4004)
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Texas
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Houston, Texas, Forente stater, 77030
- UT Physicians Rheumatology ( Site 4007)
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Wisconsin
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Milwaukee, Wisconsin, Forente stater, 53226
- Froedtert and Medical College of Wisconsin ( Site 4012)
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Paris, Frankrike, 75679
- Hopital Cochin ( Site 4203)
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Nord
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Bordeaux, Nord, Frankrike, 33076
- CHU de Bordeaux. Hopital Pellegrin ( Site 4202)
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Lille, Nord, Frankrike, 59000
- Hôpital Claude Huriez ( Site 4200)
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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, Italia, 50141
- Azienda Ospedaliera Universitaria Careggi ( Site 4301)
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Genova, Italia, 16132
- Ospedale Policlinico San Martino ( Site 4305)
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Milan, Italia, 20122
- IRCCS Osp. Maggiore Policlinico ( Site 4306)
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Milan, Italia, 20132
- Ospedale San Raffaele di Milano ( Site 4307)
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Pavia, Italia, 27100
- Fondazione IRCCS Policlinico San Matteo ( Site 4303)
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Reggio Emilia, Italia, 42123
- Arcispedale Santa Maria Nuova ( Site 4300)
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Roma, Italia, 00161
- Azienda Policlinico Umberto I ( Site 4302)
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Piedmont
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Turin, Piedmont, Italia, 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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Gelderland
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Nijmegen, Gelderland, Nederland, 6500 HB
- Radboud University Medical Center ( Site 4650)
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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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Barcelona, Spania, 08035
- Hospital Universitario Vall d'Hebron - PPDS ( Site 4107)
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Barcelona, Spania, 08041
- Hospital Santa Creu i Sant Pau ( Site 4102)
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Madrid, Spania, 28034
- Hospital Universitario Ramon y Cajal ( Site 4101)
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Málaga, Spania, 29009
- Hospital Regional Universitario de Malaga ( Site 4104)
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Valencia, Spania, 46017
- Hospital Universitario Doctor Peset ( Site 4103)
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Zaragoza, Spania, 50009
- Hospital Clinico Universitario Lozano Blesa ( Site 4100)
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Catalonia
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Barcelona, Catalonia, Spania, 08036
- HOSPITAL CLÍNIC DE BARCELONA ( Site 4105)
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, Spania, 28041
- Hospital Universitario 12 de Octubre ( Site 4106)
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Principality of Asturias
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Oviedo, Principality of Asturias, Spania, 33011
- Hospital Central de Asturias ( Site 4109)
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Leeds, Storbritannia, LS7 4SA
- Chapel Allerton Hospital ( Site 4551)
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London, City of
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London, London, City of, Storbritannia, NW3 2QG
- Royal Free Hospital ( Site 4550)
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Geneva, Sveits, 1211
- Hopitaux Universitaires de Geneve HUG ( Site 4503)
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Zurich, Sveits, 8091
- Universitaetsspital Zuerich ( Site 4500)
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Canton of Bern
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Bern, Canton of Bern, Sveits, 3010
- Inselspital Bern ( Site 4502)
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Canton of St. Gallen
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Sankt Gallen, Canton of St. Gallen, Sveits, 9007
- Kantonsspital St. Gallen ( Site 4501)
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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, Ukraina, 02091
- Medical Center OK!Clinic+LLC International Institute of Clinical Research ( Site 4753)
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Kyiv, Ukraina, 2081
- Institute of Rheumatology LLC ( Site 4752)
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Kyivska Oblast
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Kyiv, Kyivska Oblast, Ukraina, 02125
- Kyiv City Clinical Hospital # 3 ( Site 4754)
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Ternopil Oblast
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Ternopil, Ternopil Oblast, Ukraina, 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, Ukraina, 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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Tulisokibart
Tulisokibart IV administered by IV infusion |
Tulisokibart administered at timepoints as directed by the protocol
Andre navn:
CDx+ or CDx- |
|
Placebo komparator: Placebo
Placebo administered by IV infusion |
Placebo CDx+ or CDx- |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Prometheus Biosciences, Clinical Trials Call Center
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
29. mars 2022
Primær fullføring (Faktiske)
16. april 2026
Studiet fullført (Antatt)
16. november 2026
Datoer for studieregistrering
Først innsendt
27. februar 2022
Først innsendt som oppfylte QC-kriteriene
7. mars 2022
Først lagt ut (Faktiske)
8. mars 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 7240-007
- PR200-104 (Annen identifikator: PrometheusBio)
- 2021-005206-10 (EudraCT-nummer)
- MK-7240-007 (Annen identifikator: MSD)
- U1111-1309-6150 (Registeridentifikator: UTN)
- 2023-509743-27-00 (Registeridentifikator: EU CT)
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .