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)
NCT ID: NCT05270668
Last Updated: 2025-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
154 participants
INTERVENTIONAL
2022-03-29
2029-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tulisokibart
Tulisokibart IV administered by IV infusion
Tulisokibart
Tulisokibart administered at timepoints as directed by the protocol
Companion diagnostic ( CDx)
CDx+ or CDx-
Placebo
Placebo administered by IV infusion
Companion diagnostic ( CDx)
CDx+ or CDx-
Placebo
Placebo
Interventions
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Tulisokibart
Tulisokibart administered at timepoints as directed by the protocol
Companion diagnostic ( CDx)
CDx+ or CDx-
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
INDUSTRY
Responsible Party
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Principal Investigators
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Prometheus Biosciences
Role: STUDY_DIRECTOR
Clinical Trials Call Center
Locations
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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
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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PR200-104
Identifier Type: OTHER
Identifier Source: secondary_id
MK-7240-007
Identifier Type: OTHER
Identifier Source: secondary_id
2023-509743-27-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1309-6150
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-005206-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
7240-007
Identifier Type: -
Identifier Source: org_study_id
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