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

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment154 (actual)
SponsorPrometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Industry-sponsored
Drugs / interventionsTulisokibart, Companion diagnostic ( CDx), Placebo
Locations95 sites (Argentina, Australia, Belgium, Canada, Chile, France, Germany, Hungary and more)
Trial IDNCT05270668 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

  • 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
  • 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

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. 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.