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ACTIVE NOT RECRUITING
NCT05270668
PHASE2

Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007)

Sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.

Official title: A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-7240/PRA023 in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

154

Start Date

2022-03-29

Completion Date

2029-07-31

Last Updated

2025-10-20

Healthy Volunteers

No

Interventions

DRUG

Tulisokibart

Tulisokibart administered at timepoints as directed by the protocol

DIAGNOSTIC_TEST

Companion diagnostic ( CDx)

CDx+ or CDx-

DRUG

Placebo

Placebo

Locations (95)

Mayo Clinic - Scottsdale ( Site 4014)

Phoenix, Arizona, United States

Pacific Arthritis Care Center ( Site 4008)

Los Angeles, California, United States

Cedars Sinai Medical Center ( Site 4010)

Los Angeles, California, United States

UCLA School of Medicine ( Site 4006)

Los Angeles, California, United States

Stanford Health Care ( Site 4009)

Palo Alto, California, United States

National Jewish Health Medical Center ( Site 4015)

Denver, Colorado, United States

Yale University ( Site 4017)

New Haven, Connecticut, United States

MedStar Georgetown University Hospital ( Site 4005)

Washington D.C., District of Columbia, United States

Johns Hopkins Asthma and Allergy Center [Baltimore, MD] ( Site 4018)

Baltimore, Maryland, United States

Massachusetts General Hospital ( Site 4003)

Boston, Massachusetts, United States

Boston University School of Medicine ( Site 4021)

Boston, Massachusetts, United States

University of Michigan Hospital ( Site 4001)

Ann Arbor, Michigan, United States

Rutgers Robert Wood Johnson Medical School ( Site 4013)

New Brunswick, New Jersey, United States

Hospital For Special Surgery ( Site 4020)

New York, New York, United States

Cleveland Clinic Foundation ( Site 4019)

Cleveland, Ohio, United States

University of Toledo Medical Center ( Site 4002)

Toledo, Ohio, United States

University of Pittsburgh Medical Center ( Site 4016)

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina - PPDS ( Site 4004)

Charleston, South Carolina, United States

UT Physicians Rheumatology ( Site 4007)

Houston, Texas, United States

Froedtert and Medical College of Wisconsin ( Site 4012)

Milwaukee, Wisconsin, United States

Consultorios Médicos Dr. Doreski ( Site 4800)

CABA, Buenos Aires, Argentina

Clínica Privada Independencia ( Site 4802)

Munro, Buenos Aires, Argentina

Centro de Investigación Instituto Médico Río Cuarto ( Site 4801)

Río Cuarto, Córdoba Province, Argentina

Instituto Medico de la Fundacion Estudios Clinicos ( Site 4803)

Rosario, Santa Fe Province, Argentina

Royal Adelaide Hospital ( Site 4050)

Adelaide, South Australia, Australia

St Vincents Hospital Melbourne ( Site 4051)

Melbourne, Victoria, Australia

UZ Gent ( Site 4401)

Ghent, Oost-Vlaanderen, Belgium

UZ Leuven ( Site 4402)

Leuven, Vlaams-Brabant, Belgium

CHU de Liege ( Site 4400)

Liège, Wallonne, Region, Belgium

University Of Alberta Hospital ( Site 4702)

Edmonton, Alberta, Canada

St. Joseph's Health Care London ( Site 4701)

London, Ontario, Canada

Mount Sinai Hospital [Toronto, Canada] ( Site 4700)

Toronto, Ontario, Canada

BIOCINETIC Ltda ( Site 4854)

Santiago, Region M. de Santiago, Chile

Centro de Investigacion Clinica UC CICUC ( Site 4855)

Santiago, Region M. de Santiago, Chile

Centro Internacional de Estudios Clinicos CIEC ( Site 4851)

Santiago, Region M. de Santiago, Chile

Clinica Dermacross ( Site 4853)

Vitacura, Region M. de Santiago, Chile

Centro de especialidades médicas Vanguardia ( Site 4850)

Temuco, Región de la Araucanía, Chile

ONCOCENTRO APYS ( Site 4852)

Viña del Mar, Región de Valparaíso, Chile

CHU de Bordeaux. Hopital Pellegrin ( Site 4202)

Bordeaux, Nord, France

Hôpital Claude Huriez ( Site 4200)

Lille, Nord, France

Hopital Cochin ( Site 4203)

Paris, France

Universitaetsklinikum Freiburg ( Site 4152)

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Kerckhoff-Klinik-Forschungs-GmbH ( Site 4153)

Bad Nauheim, Hesse, Germany

Rheumazentrum am Krankenhaus Bad Doberan ( Site 4150)

Hohenfelde B Bad Doberan, Mecklenburg-Vorpommern, Germany

Universitaetsklinikum Koeln ( Site 4151)

Cologne, North Rhine-Westphalia, Germany

Pecsi Tudomanyegyetem AOK ( Site 4250)

Pécs, Baranya, Hungary

Budai Irgalmasrendi Korhaz ( Site 4252)

Budapest, Hungary

Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet ( Site 4253)

Budapest, Hungary

Debreceni Egyetem Klinikai Kozpont ( Site 4251)

Debrecen, Hungary

Rambam Medical Center ( Site 4601)

Haifa, Israel

Meir Medical Center. ( Site 4604)

Kfar Saba, Israel

Galilee Medical Center ( Site 4602)

Nahariya, Israel

Rabin Medical Center ( Site 4603)

Petach Tikvah, Israel

Sheba Medical Center ( Site 4605)

Ramat Gan, Israel

Tel Aviv Sourasky Medical Center ( Site 4606)

Tel Aviv, Israel

A.O.U. Citta della Salute e della Scienza di Torino ( Site 4304)

Turin, Piedmont, Italy

Azienda Ospedaliera Universitaria Careggi ( Site 4301)

Florence, Italy

Ospedale Policlinico San Martino ( Site 4305)

Genova, Italy

IRCCS Osp. Maggiore Policlinico ( Site 4306)

Milan, Italy

Ospedale San Raffaele di Milano ( Site 4307)

Milan, Italy

Fondazione IRCCS Policlinico San Matteo ( Site 4303)

Pavia, Italy

Arcispedale Santa Maria Nuova ( Site 4300)

Reggio Emilia, Italy

Azienda Policlinico Umberto I ( Site 4302)

Roma, Italy

PanAmerican Clinical Research - Guadalajara ( Site 4900)

Guadalajara, Jalisco, Mexico

Centro de Investigación y Tratamiento Reumatológico S.C ( Site 4902)

Mexico City, Mexico City, Mexico

Radboud University Medical Center ( Site 4650)

Nijmegen, Gelderland, Netherlands

Oslo Universitetssykehus HF. Rikshospitalet ( Site 4350)

Oslo, Norway

Instituto de Ginecologia y Reproduccion ( Site 4952)

Lima, Peru

Twoja Przychodnia Poznanskie Centrum Medyczne ( Site 4452)

Poznan, Greater Poland Voivodeship, Poland

Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartanska 1 ( Site

Warszawa, Greater Poland Voivodeship, Poland

Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy ( Site 4454)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Centrum Medyczne Oporow ( Site 4455)

Wroclaw, Lower Silesian Voivodeship, Poland

Centrum Medyczne Reuma Park NZOZ ( Site 4450)

Warsaw, Masovian Voivodeship, Poland

Uniwersytecki Szpital Kliniczny w Bialymstoku - Marii Sklodowskiej-Curie 24A ( Site 4451)

Bialystok, Podlaskie Voivodeship, Poland

Szpital Specjalistyczny nr 1 w Bytomiu ( Site 4453)

Bytom, Silesian Voivodeship, Poland

HOSPITAL CLÍNIC DE BARCELONA ( Site 4105)

Barcelona, Catalonia, Spain

Hospital Universitario 12 de Octubre ( Site 4106)

Madrid, Madrid, Comunidad de, Spain

Hospital Central de Asturias ( Site 4109)

Oviedo, Principality of Asturias, Spain

Hospital Universitario Vall d'Hebron - PPDS ( Site 4107)

Barcelona, Spain

Hospital Santa Creu i Sant Pau ( Site 4102)

Barcelona, Spain

Hospital Universitario Ramon y Cajal ( Site 4101)

Madrid, Spain

Hospital Regional Universitario de Malaga ( Site 4104)

Málaga, Spain

Hospital Universitario Doctor Peset ( Site 4103)

Valencia, Spain

Hospital Clinico Universitario Lozano Blesa ( Site 4100)

Zaragoza, Spain

Inselspital Bern ( Site 4502)

Bern, Canton of Bern, Switzerland

Kantonsspital St. Gallen ( Site 4501)

Sankt Gallen, Canton of St. Gallen, Switzerland

Hopitaux Universitaires de Geneve HUG ( Site 4503)

Geneva, Switzerland

Universitaetsspital Zuerich ( Site 4500)

Zurich, Switzerland

Kyiv City Clinical Hospital # 3 ( Site 4754)

Kyiv, Kyivska Oblast, Ukraine

ME "Ternopil Regional Clinical Hospital of Ternopil Regional Council" ( Site 4750)

Ternopil, Ternopil Oblast, Ukraine

Vinnytsia Nat Med University n.a.M.Pyrogov,City Clinical Hospital #1 ( Site 4751)

Vinnytsia, Vinnytsia Oblast, Ukraine

Medical Center OK!Clinic+LLC International Institute of Clinical Research ( Site 4753)

Kyiv, Ukraine

Institute of Rheumatology LLC ( Site 4752)

Kyiv, Ukraine

Royal Free Hospital ( Site 4550)

London, London, City of, United Kingdom

Chapel Allerton Hospital ( Site 4551)

Leeds, United Kingdom