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New drug aims to slow lung damage in rare autoimmune disease

NCT ID NCT05270668

Disease control Sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether tulisokibart can safely slow lung scarring in people with systemic sclerosis and interstitial lung disease. About 154 participants will receive either the drug or a placebo. The main goal is to see if the drug reduces the yearly decline in lung function over 50 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tulisokibart (also called PRA023 or MK-7240)
What this could lead to
If successful, this could provide a new treatment option to slow lung scarring and preserve breathing function in people with systemic sclerosis-related lung disease.
What could go wrong
This is a mid-stage trial with only 154 participants, so results may not apply to everyone. The drug may not prove more effective than placebo, and side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

154 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diffuse cutaneous systemic sclerosis diffuse scleroderma interstitial lung disease pulmonary systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diffuse cutaneous systemic sclerosis Interstitial lung disease

Contacts and locations

Locations

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

    Turin, Piedmont, 10126, Italy

  • Arcispedale Santa Maria Nuova ( Site 4300)

    Reggio Emilia, 42123, Italy

  • Azienda Ospedaliera Universitaria Careggi ( Site 4301)

    Florence, 50141, Italy

  • Azienda Policlinico Umberto I ( Site 4302)

    Roma, 00161, Italy

  • BIOCINETIC Ltda ( Site 4854)

    Santiago, Region M. de Santiago, 8320000, Chile

  • Boston University School of Medicine ( Site 4021)

    Boston, Massachusetts, 02118, United States

  • Budai Irgalmasrendi Korhaz ( Site 4252)

    Budapest, 1023, Hungary

  • CHU de Bordeaux. Hopital Pellegrin ( Site 4202)

    Bordeaux, Nord, 33076, France

  • CHU de Liege ( Site 4400)

    Liège, Wallonne, Region, 4000, Belgium

  • Cedars Sinai Medical Center ( Site 4010)

    Los Angeles, California, 90048, United States

  • Centro Internacional de Estudios Clinicos CIEC ( Site 4851)

    Santiago, Region M. de Santiago, 8420383, Chile

  • Centro de Investigacion Clinica UC CICUC ( Site 4855)

    Santiago, Region M. de Santiago, 8330034, Chile

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

    Río Cuarto, Córdoba Province, 5800, Argentina

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

    Mexico City, Mexico City, 31000, Mexico

  • Centro de especialidades médicas Vanguardia ( Site 4850)

    Temuco, Araucania, 4780000, Chile

  • Centrum Medyczne Oporow ( Site 4455)

    Wroclaw, Lower Silesian Voivodeship, 52-416, Poland

  • Centrum Medyczne Reuma Park NZOZ ( Site 4450)

    Warsaw, Masovian Voivodeship, 02-691, Poland

  • Chapel Allerton Hospital ( Site 4551)

    Leeds, LS7 4SA, United Kingdom

  • Cleveland Clinic Foundation ( Site 4019)

    Cleveland, Ohio, 44195, United States

  • Clinica Dermacross ( Site 4853)

    Vitacura, Region M. de Santiago, 7640881, Chile

  • Clínica Privada Independencia ( Site 4802)

    Munro, Buenos Aires, 1605, Argentina

  • Consultorios Médicos Dr. Doreski ( Site 4800)

    CABA, Buenos Aires, C1426ABP, Argentina

  • Debreceni Egyetem Klinikai Kozpont ( Site 4251)

    Debrecen, 4032, Hungary

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

    Budapest, 1097, Hungary

  • Fondazione IRCCS Policlinico San Matteo ( Site 4303)

    Pavia, 27100, Italy

  • Froedtert and Medical College of Wisconsin ( Site 4012)

    Milwaukee, Wisconsin, 53226, United States

  • Galilee Medical Center ( Site 4602)

    Nahariya, 2210001, Israel

  • HOSPITAL CLÍNIC DE BARCELONA ( Site 4105)

    Barcelona, Catalonia, 08036, Spain

  • Hopital Cochin ( Site 4203)

    Paris, 75679, France

  • Hopitaux Universitaires de Geneve HUG ( Site 4503)

    Geneva, 1211, Switzerland

  • Hospital Central de Asturias ( Site 4109)

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Clinico Universitario Lozano Blesa ( Site 4100)

    Zaragoza, 50009, Spain

  • Hospital For Special Surgery ( Site 4020)

    New York, New York, 10021, United States

  • Hospital Regional Universitario de Malaga ( Site 4104)

    Málaga, 29009, Spain

  • Hospital Santa Creu i Sant Pau ( Site 4102)

    Barcelona, 08041, Spain

  • Hospital Universitario 12 de Octubre ( Site 4106)

    Madrid, Madrid, Comunidad de, 28041, Spain

  • Hospital Universitario Doctor Peset ( Site 4103)

    Valencia, 46017, Spain

  • Hospital Universitario Ramon y Cajal ( Site 4101)

    Madrid, 28034, Spain

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

    Barcelona, 08035, Spain

  • Hôpital Claude Huriez ( Site 4200)

    Lille, Nord, 59000, France

  • IRCCS Osp. Maggiore Policlinico ( Site 4306)

    Milan, 20122, Italy

  • Inselspital Bern ( Site 4502)

    Bern, Canton of Bern, 3010, Switzerland

  • Institute of Rheumatology LLC ( Site 4752)

    Kyiv, 2081, Ukraine

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

    Rosario, Santa Fe Province, S2000CEJ, Argentina

  • Instituto de Ginecologia y Reproduccion ( Site 4952)

    Lima, 15023, Peru

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

    Baltimore, Maryland, 21224, United States

  • Kantonsspital St. Gallen ( Site 4501)

    Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

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

    Bad Nauheim, Hesse, 61231, Germany

  • Kyiv City Clinical Hospital # 3 ( Site 4754)

    Kyiv, Kyivska Oblast, 02125, Ukraine

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

    Ternopil, Ternopil Oblast, 46002, Ukraine

  • Massachusetts General Hospital ( Site 4003)

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic - Scottsdale ( Site 4014)

    Phoenix, Arizona, 85054, United States

  • MedStar Georgetown University Hospital ( Site 4005)

    Washington D.C., District of Columbia, 20007, United States

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

    Kyiv, 02091, Ukraine

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

    Charleston, South Carolina, 29425, United States

  • Meir Medical Center. ( Site 4604)

    Kfar Saba, 4428164, Israel

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

    Toronto, Ontario, M5T 3L9, Canada

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

    Warszawa, Greater Poland Voivodeship, 02-637, Poland

  • National Jewish Health Medical Center ( Site 4015)

    Denver, Colorado, 80206, United States

  • ONCOCENTRO APYS ( Site 4852)

    Viña del Mar, Valparaiso, 2520598, Chile

  • Oslo Universitetssykehus HF. Rikshospitalet ( Site 4350)

    Oslo, 0372, Norway

  • Ospedale Policlinico San Martino ( Site 4305)

    Genova, 16132, Italy

  • Ospedale San Raffaele di Milano ( Site 4307)

    Milan, 20132, Italy

  • Pacific Arthritis Care Center ( Site 4008)

    Los Angeles, California, 90045, United States

  • PanAmerican Clinical Research - Guadalajara ( Site 4900)

    Guadalajara, Jalisco, 44670, Mexico

  • Pecsi Tudomanyegyetem AOK ( Site 4250)

    Pécs, Baranya, 7632, Hungary

  • Rabin Medical Center ( Site 4603)

    Petach Tikvah, 49100, Israel

  • Radboud University Medical Center ( Site 4650)

    Nijmegen, Gelderland, 6500 HB, Netherlands

  • Rambam Medical Center ( Site 4601)

    Haifa, 3109601, Israel

  • Rheumazentrum am Krankenhaus Bad Doberan ( Site 4150)

    Hohenfelde B Bad Doberan, Mecklenburg-Vorpommern, 18209, Germany

  • Royal Adelaide Hospital ( Site 4050)

    Adelaide, South Australia, 5000, Australia

  • Royal Free Hospital ( Site 4550)

    London, London, City of, NW3 2QG, United Kingdom

  • Rutgers Robert Wood Johnson Medical School ( Site 4013)

    New Brunswick, New Jersey, 08901, United States

  • Sheba Medical Center ( Site 4605)

    Ramat Gan, 5265601, Israel

  • St Vincents Hospital Melbourne ( Site 4051)

    Melbourne, Victoria, 3065, Australia

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

    London, Ontario, N6A 4V2, Canada

  • Stanford Health Care ( Site 4009)

    Palo Alto, California, 94304, United States

  • Szpital Specjalistyczny nr 1 w Bytomiu ( Site 4453)

    Bytom, Silesian Voivodeship, 41-902, Poland

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

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland

  • Tel Aviv Sourasky Medical Center ( Site 4606)

    Tel Aviv, 6423906, Israel

  • Twoja Przychodnia Poznanskie Centrum Medyczne ( Site 4452)

    Poznan, Greater Poland Voivodeship, 61-293, Poland

  • UCLA School of Medicine ( Site 4006)

    Los Angeles, California, 90095-1670, United States

  • UT Physicians Rheumatology ( Site 4007)

    Houston, Texas, 77030, United States

  • UZ Gent ( Site 4401)

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • UZ Leuven ( Site 4402)

    Leuven, Vlaams-Brabant, 3000, Belgium

  • Universitaetsklinikum Freiburg ( Site 4152)

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Universitaetsklinikum Koeln ( Site 4151)

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Universitaetsspital Zuerich ( Site 4500)

    Zurich, 8091, Switzerland

  • University Of Alberta Hospital ( Site 4702)

    Edmonton, Alberta, T6G 1W9, Canada

  • University of Michigan Hospital ( Site 4001)

    Ann Arbor, Michigan, 48109, United States

  • University of Pittsburgh Medical Center ( Site 4016)

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Toledo Medical Center ( Site 4002)

    Toledo, Ohio, 43614, United States

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

    Bialystok, Podlaskie Voivodeship, 15-276, Poland

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

    Vinnytsia, Vinnytsia Oblast, 21018, Ukraine

  • Yale University ( Site 4017)

    New Haven, Connecticut, 06519, United States

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