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)

NCT05270668 | Active Not Recruiting Phase 2 DMC FDA Drug FDA Device

• 6 other identifiers: 7240-007PR200-104MK-7240-0072023-509743-27-00U1111-1309-61502021-005206-10
• Study Type: interventional
• Target: 154
• Locations: 20 countries
• Sites: 95

Brief Summary

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

Conditions

Diffuse Cutaneous Systemic Sclerosis; Interstitial Lung Disease

Keywords

ATHENA SSc-ILD; ATHENA; Diffuse Cutaneous Scleroderma; Interstitial Lung Disease

Outcome Measures

Primary Outcomes (4)

• Number of Participants who Experience an Adverse Event (AE)

  An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants who experience an AE will be reported.

  Up to Week 50

• Number of Participants who Experience a Serious Adverse Event (SAE)

  An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants who experience an SAE will be reported.

  Up to Week 50

• Number of Participants who Discontinue due to an AE

  An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants who discontinue due to an AE will be reported.

  Up to Week 50

• Change from Baseline in the Annual Rate of Change in Forced Vital Capacity (FVC) at Week 50

  FVC, as measured in milliliters by spirometry, is the amount of air forcibly exhaled from the lungs after taking the deepest breath possible.

  Baseline and up to Week 50

Secondary Outcomes (5)

• Change from Baseline in FVC at Week 50

  Baseline and Week 50

• Change from Baseline in High-Resolution Computer Tomography (HRCT) Quantitative Interstitial Lung Disease - Whole Lung (QILD-WL) at Week 50

  Baseline and Week 50

• Percentage of Participants with an Improvement in the Revised Composite Response Index in Systemic Sclerosis (CRISS) Score at Week 50

  Baseline and Week 50

• Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 50

  Baseline and Week 50

• Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Quality of Life (QoL) Outcome at Week 50

  Baseline and Week 50

Study Arms (2)

Tulisokibart

EXPERIMENTAL

Tulisokibart IV administered by IV infusion

Drug: Tulisokibart; Diagnostic Test: Companion diagnostic ( CDx)

Placebo

PLACEBO COMPARATOR

Placebo administered by IV infusion

Diagnostic Test: Companion diagnostic ( CDx); Drug: Placebo

Interventions

Tulisokibart DRUG

Tulisokibart administered at timepoints as directed by the protocol

Also known as: PRA023, MK-7240

Tulisokibart

Companion diagnostic ( CDx) DIAGNOSTIC_TEST

CDx+ or CDx-

Placebo; Tulisokibart

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): lead

Study Sites (95)

Mayo Clinic - Scottsdale ( Site 4014)

Phoenix, Arizona, 85054, United States

Location

Pacific Arthritis Care Center ( Site 4008)

Los Angeles, California, 90045, United States

Location

Cedars Sinai Medical Center ( Site 4010)

Los Angeles, California, 90048, United States

Location

UCLA School of Medicine ( Site 4006)

Los Angeles, California, 90095-1670, United States

Location

Stanford Health Care ( Site 4009)

Palo Alto, California, 94304, United States

Location

National Jewish Health Medical Center ( Site 4015)

Denver, Colorado, 80206, United States

Location

Yale University ( Site 4017)

New Haven, Connecticut, 06519, United States

Location

MedStar Georgetown University Hospital ( Site 4005)

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

Location

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

Baltimore, Maryland, 21224, United States

Location

Massachusetts General Hospital ( Site 4003)

Boston, Massachusetts, 02114, United States

Location

Boston University School of Medicine ( Site 4021)

Boston, Massachusetts, 02118, United States

Location

University of Michigan Hospital ( Site 4001)

Ann Arbor, Michigan, 48109, United States

Location

Rutgers Robert Wood Johnson Medical School ( Site 4013)

New Brunswick, New Jersey, 08901, United States

Location

Hospital For Special Surgery ( Site 4020)

New York, New York, 10021, United States

Location

Cleveland Clinic Foundation ( Site 4019)

Cleveland, Ohio, 44195, United States

Location

University of Toledo Medical Center ( Site 4002)

Toledo, Ohio, 43614, United States

Location

University of Pittsburgh Medical Center ( Site 4016)

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina - PPDS ( Site 4004)

Charleston, South Carolina, 29425, United States

Location

UT Physicians Rheumatology ( Site 4007)

Houston, Texas, 77030, United States

Location

Froedtert and Medical College of Wisconsin ( Site 4012)

Milwaukee, Wisconsin, 53226, United States

Location

Consultorios Médicos Dr. Doreski ( Site 4800)

CABA, Buenos Aires, C1426ABP, Argentina

Location

Clínica Privada Independencia ( Site 4802)

Munro, Buenos Aires, 1605, Argentina

Location

Centro de Investigación Instituto Médico Río Cuarto ( Site 4801)

Río Cuarto, Córdoba Province, 5800, Argentina

Location

Instituto Medico de la Fundacion Estudios Clinicos ( Site 4803)

Rosario, Santa Fe Province, S2000CEJ, Argentina

Location

Royal Adelaide Hospital ( Site 4050)

Adelaide, South Australia, 5000, Australia

Location

St Vincents Hospital Melbourne ( Site 4051)

Melbourne, Victoria, 3065, Australia

Location

UZ Gent ( Site 4401)

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

UZ Leuven ( Site 4402)

Leuven, Vlaams-Brabant, 3000, Belgium

Location

CHU de Liege ( Site 4400)

Liège, Wallonne, Region, 4000, Belgium

Location

University Of Alberta Hospital ( Site 4702)

Edmonton, Alberta, T6G 1W9, Canada

Location

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

London, Ontario, N6A 4V2, Canada

Location

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

Toronto, Ontario, M5T 3L9, Canada

Location

BIOCINETIC Ltda ( Site 4854)

Santiago, Region M. de Santiago, 8320000, Chile

Location

Centro de Investigacion Clinica UC CICUC ( Site 4855)

Santiago, Region M. de Santiago, 8330034, Chile

Location

Centro Internacional de Estudios Clinicos CIEC ( Site 4851)

Santiago, Region M. de Santiago, 8420383, Chile

Location

Clinica Dermacross ( Site 4853)

Vitacura, Region M. de Santiago, 7640881, Chile

Location

Centro de especialidades médicas Vanguardia ( Site 4850)

Temuco, Región de la Araucanía, 4780000, Chile

Location

ONCOCENTRO APYS ( Site 4852)

Viña del Mar, Región de Valparaíso, 2520598, Chile

Location

CHU de Bordeaux. Hopital Pellegrin ( Site 4202)

Bordeaux, Nord, 33076, France

Location

Hôpital Claude Huriez ( Site 4200)

Lille, Nord, 59000, France

Location

Hopital Cochin ( Site 4203)

Paris, 75679, France

Location

Universitaetsklinikum Freiburg ( Site 4152)

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Kerckhoff-Klinik-Forschungs-GmbH ( Site 4153)

Bad Nauheim, Hesse, 61231, Germany

Location

Rheumazentrum am Krankenhaus Bad Doberan ( Site 4150)

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

Location

Universitaetsklinikum Koeln ( Site 4151)

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Pecsi Tudomanyegyetem AOK ( Site 4250)

Pécs, Baranya, 7632, Hungary

Location

Budai Irgalmasrendi Korhaz ( Site 4252)

Budapest, 1023, Hungary

Location

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

Budapest, 1097, Hungary

Location

Debreceni Egyetem Klinikai Kozpont ( Site 4251)

Debrecen, 4032, Hungary

Location

Rambam Medical Center ( Site 4601)

Haifa, 3109601, Israel

Location

Meir Medical Center. ( Site 4604)

Kfar Saba, 4428164, Israel

Location

Galilee Medical Center ( Site 4602)

Nahariya, 2210001, Israel

Location

Rabin Medical Center ( Site 4603)

Petach Tikvah, 49100, Israel

Location

Sheba Medical Center ( Site 4605)

Ramat Gan, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center ( Site 4606)

Tel Aviv, 6423906, Israel

Location

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

Turin, Piedmont, 10126, Italy

Location

Azienda Ospedaliera Universitaria Careggi ( Site 4301)

Florence, 50141, Italy

Location

Ospedale Policlinico San Martino ( Site 4305)

Genova, 16132, Italy

Location

IRCCS Osp. Maggiore Policlinico ( Site 4306)

Milan, 20122, Italy

Location

Ospedale San Raffaele di Milano ( Site 4307)

Milan, 20132, Italy

Location

Fondazione IRCCS Policlinico San Matteo ( Site 4303)

Pavia, 27100, Italy

Location

Arcispedale Santa Maria Nuova ( Site 4300)

Reggio Emilia, 42123, Italy

Location

Azienda Policlinico Umberto I ( Site 4302)

Roma, 00161, Italy

Location

PanAmerican Clinical Research - Guadalajara ( Site 4900)

Guadalajara, Jalisco, 44670, Mexico

Location

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

Mexico City, Mexico City, 31000, Mexico

Location

Radboud University Medical Center ( Site 4650)

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Oslo Universitetssykehus HF. Rikshospitalet ( Site 4350)

Oslo, 0372, Norway

Location

Instituto de Ginecologia y Reproduccion ( Site 4952)

Lima, 15023, Peru

Location

Twoja Przychodnia Poznanskie Centrum Medyczne ( Site 4452)

Poznan, Greater Poland Voivodeship, 61-293, Poland

Location

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

Warszawa, Greater Poland Voivodeship, 02-637, Poland

Location

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

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

Location

Centrum Medyczne Oporow ( Site 4455)

Wroclaw, Lower Silesian Voivodeship, 52-416, Poland

Location

Centrum Medyczne Reuma Park NZOZ ( Site 4450)

Warsaw, Masovian Voivodeship, 02-691, Poland

Location

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

Bialystok, Podlaskie Voivodeship, 15-276, Poland

Location

Szpital Specjalistyczny nr 1 w Bytomiu ( Site 4453)

Bytom, Silesian Voivodeship, 41-902, Poland

Location

HOSPITAL CLÍNIC DE BARCELONA ( Site 4105)

Barcelona, Catalonia, 08036, Spain

Location

Hospital Universitario 12 de Octubre ( Site 4106)

Madrid, Madrid, Comunidad de, 28041, Spain

Location

Hospital Central de Asturias ( Site 4109)

Oviedo, Principality of Asturias, 33011, Spain

Location

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

Barcelona, 08035, Spain

Location

Hospital Santa Creu i Sant Pau ( Site 4102)

Barcelona, 08041, Spain

Location

Hospital Universitario Ramon y Cajal ( Site 4101)

Madrid, 28034, Spain

Location

Hospital Regional Universitario de Malaga ( Site 4104)

Málaga, 29009, Spain

Location

Hospital Universitario Doctor Peset ( Site 4103)

Valencia, 46017, Spain

Location

Hospital Clinico Universitario Lozano Blesa ( Site 4100)

Zaragoza, 50009, Spain

Location

Inselspital Bern ( Site 4502)

Bern, Canton of Bern, 3010, Switzerland

Location

Kantonsspital St. Gallen ( Site 4501)

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

Location

Hopitaux Universitaires de Geneve HUG ( Site 4503)

Geneva, 1211, Switzerland

Location

Universitaetsspital Zuerich ( Site 4500)

Zurich, 8091, Switzerland

Location

Kyiv City Clinical Hospital # 3 ( Site 4754)

Kyiv, Kyivska Oblast, 02125, Ukraine

Location

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

Ternopil, Ternopil Oblast, 46002, Ukraine

Location

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

Vinnytsia, Vinnytsia Oblast, 21018, Ukraine

Location

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

Kyiv, 02091, Ukraine

Location

Institute of Rheumatology LLC ( Site 4752)

Kyiv, 2081, Ukraine

Location

Royal Free Hospital ( Site 4550)

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

Location

Chapel Allerton Hospital ( Site 4551)

Leeds, LS7 4SA, United Kingdom

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Scleroderma, Diffuse; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Prometheus Biosciences

  Clinical Trials Call Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2022
• First Posted: March 8, 2022
• Study Start: March 29, 2022
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 31, 2029
• Last Updated: October 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

AU (2); UA (5); CH (4); BE (3); IL (6); FR (3); HU (4); DE (4); PE (1); PL (7); ES (9); CA (3); IT (8); US (20); NO (1); ME (2); AR (4); GB (2); NL (1); CL (6)