Clinical trial
Phase 2
Interventional
Ages 18 and up
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)
Run by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · NCT05270668 · Data updated 2026-11-12
Fully enrolled, still running. This study is not taking new participants. Its registered completion date is 2026-04-16.
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 154 (actual) |
| Sponsor | Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) Industry-sponsored |
| Drugs / interventions | Tulisokibart, Companion diagnostic ( CDx), Placebo |
| Locations | 95 sites (Argentina, Australia, Belgium, Canada, Chile, France, Germany, Hungary and more) |
| Trial ID | NCT05270668 on ClinicalTrials.gov |
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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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
Show 44 more locations
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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 -
Centro de especialidades médicas Vanguardia ( Site 4850)
Temuco, Araucania, Chile -
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 -
ONCOCENTRO APYS ( Site 4852)
Viña del Mar, Valparaiso, 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
+45 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Prometheus Biosciences — Clinical Trials Call Center
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-15 by the Find a Trial editorial team.
Information on this page is for educational purposes and is not medical advice.
Always consult qualified healthcare professionals about clinical trial participation.