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)

Last updated: April 18, 2025
Sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Overall Status: Active - Not Recruiting

Phase

2

Condition

Lung Disease

Scar Tissue

Treatment

Placebo

PRA023 IV

Companion diagnostic ( CDx)

Clinical Study ID

NCT05270668
7240-007
2023-509743-27
U1111-1309-6150
2021-005206-10
PR200-104
MK-7240-007
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 orbreastfeeding and either willing to use an acceptable contraceptive method orsexually abstinent

  • Able to provide written informed consent and understand and comply with therequirements of the study

Exclusion

Exclusion Criteria:

  • Has an airway obstruction per pulmonary function test (PFT) or clinicallysignificant 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 chronicbacterial 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

Study Design

Total Participants: 152
Treatment Group(s): 5
Primary Treatment: Placebo
Phase: 2
Study Start date:
March 29, 2022
Estimated Completion Date:
July 31, 2029

Connect with a study center

  • Consultorios Médicos Dr. Doreski ( Site 4800)

    Caba, Buenos Aires C1426ABP
    Argentina

    Site Not Available

  • Clínica Privada Independencia ( Site 4802)

    Munro, Buenos Aires 1605
    Argentina

    Site Not Available

  • Centro de Investigación Instituto Médico Río Cuarto ( Site 4801)

    Rio Cuarto, Cordoba 5800
    Argentina

    Site Not Available

  • Instituto Medico de la Fundacion Estudios Clinicos ( Site 4803)

    Rosario, Santa Fe S2000DEJ
    Argentina

    Site Not Available

  • Instituto Medico de la Fundacion Estudios Clinicos ( Site 4803)

    Rosario., Santa Fe S2000CEJ
    Argentina

    Site Not Available

  • Prometheus Biosciences Selected Site

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • Royal Adelaide Hospital ( Site 4050)

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Prometheus Biosciences Selected Site

    Fitzroy, Victoria
    Australia

    Site Not Available

  • St Vincents Hospital Melbourne ( Site 4051)

    Melbourne, Victoria 3065
    Australia

    Site Not Available

  • CHU de Liege ( Site 4400)

    Luik, Liege 4000
    Belgium

    Site Not Available

  • Prometheus Biosciences Selected Site

    Gent, Oost-Vlaanderen 9000
    Belgium

    Active - Recruiting

  • UZ Gent ( Site 4401)

    Gent, Oost-Vlaanderen 9000
    Belgium

    Site Not Available

  • Prometheus Biosciences Selected Center

    Leuven, Vlaams Brabant 3000
    Belgium

    Active - Recruiting

  • UZ Leuven ( Site 4402)

    Leuven, Vlaams-Brabant 3000
    Belgium

    Site Not Available

  • CHU de Liege ( Site 4400)

    Liège, Wallonne, Region 4000
    Belgium

    Site Not Available

  • CHU de Liege ( Site 4400)

    Liege, 4000
    Belgium

    Site Not Available

  • Prometheus Biosciences Selected Site

    Liège, 4000
    Belgium

    Site Not Available

  • Prometheus Biosciences Call Center

    Edmonton, Alberta T6G 2C8
    Canada

    Active - Recruiting

  • University Of Alberta Hospital ( Site 4702)

    Edmonton, Alberta T6G 1W9
    Canada

    Site Not Available

  • Prometheus Biosciences Selected Site

    London, Ontario N6A 4V2
    Canada

    Active - Recruiting

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

    London, Ontario N6A 4V2
    Canada

    Site Not Available

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

    Toronto, Ontario M5T 3L9
    Canada

    Site Not Available

  • Prometheus Biosciences Selected Site

    Toronto, Ontario M5T 3L9
    Canada

    Active - Recruiting

  • Centro de especialidades médicas Vanguardia ( Site 4850)

    Temuco, Araucania 4780000
    Chile

    Site Not Available

  • BIOCINETIC Ltda ( Site 4854)

    Santiago, Region M. De Santiago 8320000
    Chile

    Site Not Available

  • Centro Internacional de Estudios Clinicos CIEC ( Site 4851)

    Santiago, Region M. De Santiago 8420383
    Chile

    Site Not Available

  • Centro de Investigacion Clinica UC CICUC ( Site 4855)

    Santiago, Region M. De Santiago 8330034
    Chile

    Site Not Available

  • Clinica Dermacross ( Site 4853)

    Vitacura, Region M. De Santiago 7640881
    Chile

    Site Not Available

  • ONCOCENTRO APYS ( Site 4852)

    Vina del Mar, Valparaiso 2520598
    Chile

    Site Not Available

  • ONCOCENTRO APYS ( Site 4852)

    Viña del Mar, Valparaiso 2520598
    Chile

    Site Not Available

  • Prometheus Biosciences Selected Site

    Bordeaux, Gironde 33076
    France

    Active - Recruiting

  • CHU de Bordeaux. Hopital Pellegrin ( Site 4202)

    Bordeaux, Nord 33076
    France

    Site Not Available

  • Hôpital Claude Huriez ( Site 4200)

    Lille, Nord 59000
    France

    Site Not Available

  • Prometheus Biosciences Selected Site

    Lille, Nord 59000
    France

    Active - Recruiting

  • Hopital Cochin ( Site 4203)

    Paris, 75679
    France

    Site Not Available

  • Prometheus Biosciences Selected Site

    Paris, 75014
    France

    Active - Recruiting

  • Universitaetsklinikum Freiburg ( Site 4152)

    Freiburg, Baden-Wurttemberg 79106
    Germany

    Site Not Available

  • Kerckhoff-Klinik-Forschungs-GmbH ( Site 4153)

    Bad Nauheim, Hessen 61231
    Germany

    Site Not Available

  • Prometheus Biosciences Selected Site

    Bad Nauheim, Hessen 61231
    Germany

    Active - Recruiting

  • Rheumazentrum am Krankenhaus Bad Doberan ( Site 4150)

    Hohenfelde B Bad Doberan, Mecklenburg-Vorpommern 18209
    Germany

    Site Not Available

  • Prometheus Biosciences Selected Site

    Köln, Nordrhein-Westfalen 50931
    Germany

    Active - Recruiting

  • Universitaetsklinikum Koeln ( Site 4151)

    Köln, Nordrhein-Westfalen 50937
    Germany

    Site Not Available

  • Prometheus Biosciences Selected Site

    Bad Doberan, 18209
    Germany

    Site Not Available

  • Prometheus Biosciences Selected Site

    Freiburg, 79106
    Germany

    Active - Recruiting

  • Pecsi Tudomanyegyetem AOK ( Site 4250)

    Pecs, Baranya 7632
    Hungary

    Site Not Available

  • Prometheus Biosciences Selected Site

    Pécs, Baranya 7632
    Hungary

    Site Not Available

  • Prometheus Biosciences Selected Site

    Debrecen, Hajdu-Bihar 4032
    Hungary

    Active - Recruiting

  • Budai Irgalmasrendi Korhaz ( Site 4252)

    Budapest, 1023
    Hungary

    Site Not Available

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

    Budapest, 1097
    Hungary

    Site Not Available

  • Prometheus Biosciences Selected Site

    Budapest, 1121
    Hungary

    Active - Recruiting

  • Debreceni Egyetem Klinikai Kozpont ( Site 4251)

    Debrecen, 4032
    Hungary

    Site Not Available

  • Prometheus Biosciences Selected Site

    Kfar Saba, HaMerkas 44281
    Israel

    Active - Recruiting

  • Prometheus Biosciences Call Center

    Nahariya, HaZafon 2210001
    Israel

    Active - Recruiting

  • Prometheus Biosciences Selected Site

    Ramat Gan, Tel-Aviv 52621
    Israel

    Site Not Available

  • Prometheus Biosciences Selected Site

    Haifa, 31096
    Israel

    Active - Recruiting

  • Rambam Medical Center ( Site 4601)

    Haifa, 3109601
    Israel

    Site Not Available

  • Meir Medical Center ( Site 4604)

    Kfar Saba, 4428164
    Israel

    Active - Recruiting

  • Meir Medical Center. ( Site 4604)

    Kfar Saba, 4428164
    Israel

    Site Not Available

  • Galilee Medical Center ( Site 4602)

    Nahariya, 2210001
    Israel

    Site Not Available

  • Rabin Medical Center ( Site 4603)

    Petach Tikvah, 49100
    Israel

    Site Not Available

  • Prometheus Biosciences Selected Site

    Petah tikva, 49100
    Israel

    Site Not Available

  • Sheba Medical Center ( Site 4605)

    Ramat-Gan, 5265601
    Israel

    Site Not Available

  • Prometheus Biosciences Selected Site

    Tel Aviv, 64239
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center ( Site 4606)

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Prometheus Biosciences Selected Site

    Reggio Emilia, Emilia-Romagne 42123
    Italy

    Active - Recruiting

  • Prometheus Biosciences Selected Site

    Roma, Lazio 00161
    Italy

    Active - Recruiting

  • Prometheus Biosciences Selected Site

    Genova, Liguria 16132
    Italy

    Active - Recruiting

  • Prometheus Biosciences Selected Site

    Pavia, Lombardia 27100
    Italy

    Active - Recruiting

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

    Torino, Piemonte 10126
    Italy

    Site Not Available

  • Prometheus Biosciences Selected Site

    Firenze, Toscana 50139
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Careggi ( Site 4301)

    Firenze, 50141
    Italy

    Site Not Available

  • Ospedale Policlinico San Martino ( Site 4305)

    Genova, 16132
    Italy

    Site Not Available

  • IRCCS Osp. Maggiore Policlinico ( Site 4306)

    Milano, 20122
    Italy

    Site Not Available

  • Ospedale San Raffaele di Milano ( Site 4307)

    Milano, 20132
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo ( Site 4303)

    Pavia, 27100
    Italy

    Site Not Available

  • Arcispedale Santa Maria Nuova ( Site 4300)

    Reggio Emilia, 42123
    Italy

    Site Not Available

  • Azienda Policlinico Umberto I ( Site 4302)

    Roma, 00161
    Italy

    Site Not Available

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

    Ciudad de México, Distrito Federal 31000
    Mexico

    Site Not Available

  • PanAmerican Clinical Research - Guadalajara ( Site 4900)

    Guadalajara, Jalisco 44670
    Mexico

    Site Not Available

  • Prometheus Biosciences Selected Site

    Nijmegen, Gelderland 6525 GA
    Netherlands

    Active - Recruiting

  • Radboud University Medical Center ( Site 4650)

    Nijmegen, Gelderland 6500 HB
    Netherlands

    Site Not Available

  • Oslo Universitetssykehus HF. Rikshospitalet ( Site 4350)

    Oslo, 0372
    Norway

    Site Not Available

  • Prometheus Biosciences Selected Site

    Oslo, N-0372
    Norway

    Active - Recruiting

  • Instituto de Ginecologia y Reproduccion ( Site 4952)

    Lima, 15023
    Peru

    Site Not Available

  • Centrum Medyczne Oporow ( Site 4455)

    Wroclaw, Dolnoslaskie 52-416
    Poland

    Site Not Available

  • Prometheus Biosciences Selected Site

    Wrocław, Dolnoslaskie 53-439
    Poland

    Site Not Available

  • Prometheus Biosciences Selected Site

    Bydgoszcz, Kujawsko-pomorskie 85-168
    Poland

    Active - Recruiting

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

    Bydgoszcz, Kujawsko-pomorskie 85-168
    Poland

    Site Not Available

  • Centrum Medyczne Reuma Park NZOZ ( Site 4450)

    Warszawa, Mazowieckie 02-691
    Poland

    Site Not Available

  • Prometheus Biosciences Selected Site

    Warszawa, Mazowieckie 02-665
    Poland

    Active - Recruiting

  • Prometheus Biosciences Selected Site

    Białystok, Podlaskie 15-276
    Poland

    Active - Recruiting

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

    Białystok, Podlaskie 15-276
    Poland

    Site Not Available

  • Prometheus Biosciences Selected Site

    Bytom, Slaskie 41-902
    Poland

    Active - Recruiting

  • Szpital Specjalistyczny nr 1 w Bytomiu ( Site 4453)

    Bytom, Slaskie 41-902
    Poland

    Site Not Available

  • Prometheus Biosciences Call Center

    Poznań, Wielkopolski 61-293
    Poland

    Active - Recruiting

  • Twoja Przychodnia Poznanskie Centrum Medyczne ( Site 4452)

    Poznań, Wielkopolskie 61-293
    Poland

    Site Not Available

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

    Warszawa, Wielkopolskie 02-637
    Poland

    Site Not Available

  • Hospital Central de Asturias ( Site 4109)

    Oviedo, Asturias 33011
    Spain

    Site Not Available

  • HOSPITAL CLÍNIC DE BARCELONA ( Site 4105)

    Barcelona, Cataluna 08036
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre ( Site 4106)

    Madrid, Madrid, Comunidad De 28041
    Spain

    Site Not Available

  • Prometheus Biosciences Selected Site

    Málaga, Malaga 29009
    Spain

    Site Not Available

  • Hospital Santa Creu i Sant Pau ( Site 4102)

    Barcelona, 08041
    Spain

    Site Not Available

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

    Barcelona, 08035
    Spain

    Site Not Available

  • Prometheus Biosciences Selected Site

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon y Cajal ( Site 4101)

    Madrid, 28034
    Spain

    Site Not Available

  • Prometheus Biosciences Selected Site

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Regional Universitario de Malaga ( Site 4104)

    Malaga, 29009
    Spain

    Site Not Available

  • Hospital Universitario Doctor Peset ( Site 4103)

    Valencia, 46017
    Spain

    Site Not Available

  • Prometheus Biosciences Selected Site

    Valencia, 46017
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario Lozano Blesa ( Site 4100)

    Zaragoza, 50009
    Spain

    Site Not Available

  • Prometheus Biosciences Selected Site

    Zaragoza, 50009
    Spain

    Active - Recruiting

  • Inselspital Bern ( Site 4502)

    Bern, Berne 3010
    Switzerland

    Site Not Available

  • Kantonsspital St. Gallen ( Site 4501)

    St. Gallen, Sankt Gallen 9007
    Switzerland

    Site Not Available

  • Prometheus Biosciences Selected Site

    Saint Gallen, Sankt Gallen (de) 9007
    Switzerland

    Site Not Available

  • Prometheus Biosciences Selected Site

    Zürich, Zurich 8091
    Switzerland

    Site Not Available

  • Prometheus Biosciences Selected Site

    Bern, 3010
    Switzerland

    Active - Recruiting

  • Prometheus Biosciences Selected Site

    Geneva, 1206
    Switzerland

    Site Not Available

  • Hopitaux Universitaires de Geneve HUG ( Site 4503)

    Geneve, 1211
    Switzerland

    Site Not Available

  • Universitaetsspital Zuerich ( Site 4500)

    Zurich, 8091
    Switzerland

    Site Not Available

  • Kyiv City Clinical Hospital # 3 ( Site 4754)

    Kyiv, Kyivska Oblast 02125
    Ukraine

    Site Not Available

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

    Ternopil, Ternopilska Oblast 46002
    Ukraine

    Site Not Available

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

    Vinnytsia, Vinnytska Oblast 21018
    Ukraine

    Site Not Available

  • Institute of Rheumatology LLC ( Site 4752)

    Kyiv, 2081
    Ukraine

    Site Not Available

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

    Kyiv, 02091
    Ukraine

    Site Not Available

  • Royal Free Hospital ( Site 4550)

    London, London, City Of NW3 2QG
    United Kingdom

    Site Not Available

  • Prometheus Biosciences Selected Site

    Leeds, West Yorkshire LS1 3EX
    United Kingdom

    Active - Recruiting

  • Chapel Allerton Hospital ( Site 4551)

    Leeds, LS7 4SA
    United Kingdom

    Site Not Available

  • Prometheus Biosciences Selected Site

    London, NW3 2QG
    United Kingdom

    Active - Recruiting

  • Mayo Clinic - Scottsdale ( Site 4014)

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • Cedars Sinai Medical Center ( Site 4010)

    Los Angeles, California 90048
    United States

    Site Not Available

  • Pacific Arthritis Care Center ( Site 4008)

    Los Angeles, California 90045
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • UCLA School of Medicine ( Site 4006)

    Los Angeles, California 90095-1670
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Stanford Health Care ( Site 4009)

    Palo Alto, California 94304
    United States

    Site Not Available

  • National Jewish Health Medical Center ( Site 4015)

    Denver, Colorado 80206
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    Denver, Colorado 80206
    United States

    Active - Recruiting

  • Prometheus Biosciences Selected Site

    New Haven, Connecticut 06519
    United States

    Active - Recruiting

  • Yale University ( Site 4017)

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • MedStar Georgetown University Hospital ( Site 4005)

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

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

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    Baltimore, Maryland 21224-6821
    United States

    Active - Recruiting

  • Boston University School of Medicine ( Site 4021)

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Massachusetts General Hospital ( Site 4003)

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    Boston, Massachusetts 02118
    United States

    Active - Recruiting

  • Prometheus Biosciences Selected Site

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • University of Michigan Hospital ( Site 4001)

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Rutgers Robert Wood Johnson Medical School ( Site 4013)

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Hospital For Special Surgery ( Site 4020)

    New York, New York 10021
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    New York, New York 10021-4823
    United States

    Active - Recruiting

  • Cleveland Clinic Foundation ( Site 4019)

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Prometheus Biosciences Selected Site

    Toledo, Ohio 43614
    United States

    Active - Recruiting

  • University of Toledo Medical Center ( Site 4002)

    Toledo, Ohio 43614
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center ( Site 4016)

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Medical University of South Carolina - PPDS ( Site 4004)

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Prometheus Biosciences Selected Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • UT Physicians Rheumatology ( Site 4007)

    Houston, Texas 77030
    United States

    Site Not Available

  • Froedtert and Medical College of Wisconsin ( Site 4012)

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Prometheus Biosciences Selected Site

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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