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) (ATHENA-SSc-ILD)

May 13, 2026 updated by: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-7240/PRA023 in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD)

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1426ABP
        • Consultorios Médicos Dr. Doreski ( Site 4800)
      • Munro, Buenos Aires, Argentina, 1605
        • Clínica Privada Independencia ( Site 4802)
    • Córdoba Province
      • Río Cuarto, Córdoba Province, Argentina, 5800
        • Centro de Investigación Instituto Médico Río Cuarto ( Site 4801)
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000CEJ
        • Instituto Medico de la Fundacion Estudios Clinicos ( Site 4803)
  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital ( Site 4050)
    • Victoria
      • Melbourne, Victoria, Australia, 3065
        • St Vincents Hospital Melbourne ( Site 4051)
  • Belgium
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent ( Site 4401)
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven ( Site 4402)
    • Wallonne, Region
      • Liège, Wallonne, Region, Belgium, 4000
        • CHU de Liege ( Site 4400)
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1W9
        • University Of Alberta Hospital ( Site 4702)
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • St. Joseph's Health Care London ( Site 4701)
      • Toronto, Ontario, Canada, M5T 3L9
        • Mount Sinai Hospital [Toronto, Canada] ( Site 4700)
  • Chile
    • Araucania
      • Temuco, Araucania, Chile, 4780000
        • Centro de especialidades médicas Vanguardia ( Site 4850)
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 8320000
        • BIOCINETIC Ltda ( Site 4854)
      • Santiago, Region M. de Santiago, Chile, 8330034
        • Centro de Investigacion Clinica UC CICUC ( Site 4855)
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Centro Internacional de Estudios Clinicos CIEC ( Site 4851)
      • Vitacura, Region M. de Santiago, Chile, 7640881
        • Clinica Dermacross ( Site 4853)
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520598
        • ONCOCENTRO APYS ( Site 4852)
  • France
      • Paris, France, 75679
        • Hopital Cochin ( Site 4203)
    • Nord
      • Bordeaux, Nord, France, 33076
        • CHU de Bordeaux. Hopital Pellegrin ( Site 4202)
      • Lille, Nord, France, 59000
        • Hôpital Claude Huriez ( Site 4200)
  • Germany
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
        • Universitaetsklinikum Freiburg ( Site 4152)
    • Hesse
      • Bad Nauheim, Hesse, Germany, 61231
        • Kerckhoff-Klinik-Forschungs-GmbH ( Site 4153)
    • Mecklenburg-Vorpommern
      • Hohenfelde B Bad Doberan, Mecklenburg-Vorpommern, Germany, 18209
        • Rheumazentrum am Krankenhaus Bad Doberan ( Site 4150)
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Universitaetsklinikum Koeln ( Site 4151)
  • Hungary
      • Budapest, Hungary, 1023
        • Budai Irgalmasrendi Korhaz ( Site 4252)
      • Budapest, Hungary, 1097
        • Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet ( Site 4253)
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont ( Site 4251)
    • Baranya
      • Pécs, Baranya, Hungary, 7632
        • Pecsi Tudomanyegyetem AOK ( Site 4250)
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Medical Center ( Site 4601)
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center. ( Site 4604)
      • Nahariya, Israel, 2210001
        • Galilee Medical Center ( Site 4602)
      • Petach Tikvah, Israel, 49100
        • Rabin Medical Center ( Site 4603)
      • Ramat Gan, Israel, 5265601
        • Sheba Medical Center ( Site 4605)
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center ( Site 4606)
  • Italy
      • Florence, Italy, 50141
        • Azienda Ospedaliera Universitaria Careggi ( Site 4301)
      • Genova, Italy, 16132
        • Ospedale Policlinico San Martino ( Site 4305)
      • Milan, Italy, 20122
        • IRCCS Osp. Maggiore Policlinico ( Site 4306)
      • Milan, Italy, 20132
        • Ospedale San Raffaele di Milano ( Site 4307)
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo ( Site 4303)
      • Reggio Emilia, Italy, 42123
        • Arcispedale Santa Maria Nuova ( Site 4300)
      • Roma, Italy, 00161
        • Azienda Policlinico Umberto I ( Site 4302)
    • Piedmont
      • Turin, Piedmont, Italy, 10126
        • A.O.U. Citta della Salute e della Scienza di Torino ( Site 4304)
  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • PanAmerican Clinical Research - Guadalajara ( Site 4900)
    • Mexico City
      • Mexico City, Mexico City, Mexico, 31000
        • Centro de Investigación y Tratamiento Reumatológico S.C ( Site 4902)
  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • Radboud University Medical Center ( Site 4650)
  • Norway
      • Oslo, Norway, 0372
        • Oslo Universitetssykehus HF. Rikshospitalet ( Site 4350)
  • Peru
      • Lima, Peru, 15023
        • Instituto de Ginecologia y Reproduccion ( Site 4952)
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 61-293
        • Twoja Przychodnia Poznanskie Centrum Medyczne ( Site 4452)
      • Warszawa, Greater Poland Voivodeship, Poland, 02-637
        • Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartanska 1 ( Site
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-168
        • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy ( Site 4454)
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 52-416
        • Centrum Medyczne Oporow ( Site 4455)
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-691
        • Centrum Medyczne Reuma Park NZOZ ( Site 4450)
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-276
        • Uniwersytecki Szpital Kliniczny w Bialymstoku - Marii Sklodowskiej-Curie 24A ( Site 4451)
    • Silesian Voivodeship
      • Bytom, Silesian Voivodeship, Poland, 41-902
        • Szpital Specjalistyczny nr 1 w Bytomiu ( Site 4453)
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron - PPDS ( Site 4107)
      • Barcelona, Spain, 08041
        • Hospital Santa Creu i Sant Pau ( Site 4102)
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal ( Site 4101)
      • Málaga, Spain, 29009
        • Hospital Regional Universitario de Malaga ( Site 4104)
      • Valencia, Spain, 46017
        • Hospital Universitario Doctor Peset ( Site 4103)
      • Zaragoza, Spain, 50009
        • Hospital Clinico Universitario Lozano Blesa ( Site 4100)
    • Catalonia
      • Barcelona, Catalonia, Spain, 08036
        • HOSPITAL CLÍNIC DE BARCELONA ( Site 4105)
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28041
        • Hospital Universitario 12 de Octubre ( Site 4106)
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Hospital Central de Asturias ( Site 4109)
  • Switzerland
      • Geneva, Switzerland, 1211
        • Hopitaux Universitaires de Geneve HUG ( Site 4503)
      • Zurich, Switzerland, 8091
        • Universitaetsspital Zuerich ( Site 4500)
    • Canton of Bern
      • Bern, Canton of Bern, Switzerland, 3010
        • Inselspital Bern ( Site 4502)
    • Canton of St. Gallen
      • Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen ( Site 4501)
  • Ukraine
      • Kyiv, Ukraine, 02091
        • Medical Center OK!Clinic+LLC International Institute of Clinical Research ( Site 4753)
      • Kyiv, Ukraine, 2081
        • Institute of Rheumatology LLC ( Site 4752)
    • Kyivska Oblast
      • Kyiv, Kyivska Oblast, Ukraine, 02125
        • Kyiv City Clinical Hospital # 3 ( Site 4754)
    • Ternopil Oblast
      • Ternopil, Ternopil Oblast, Ukraine, 46002
        • ME "Ternopil Regional Clinical Hospital of Ternopil Regional Council" ( Site 4750)
    • Vinnytsia Oblast
      • Vinnytsia, Vinnytsia Oblast, Ukraine, 21018
        • Vinnytsia Nat Med University n.a.M.Pyrogov,City Clinical Hospital #1 ( Site 4751)
  • United Kingdom
      • Leeds, United Kingdom, LS7 4SA
        • Chapel Allerton Hospital ( Site 4551)
    • London, City of
      • London, London, City of, United Kingdom, NW3 2QG
        • Royal Free Hospital ( Site 4550)
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic - Scottsdale ( Site 4014)
    • California
      • Los Angeles, California, United States, 90045
        • Pacific Arthritis Care Center ( Site 4008)
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center ( Site 4010)
      • Los Angeles, California, United States, 90095-1670
        • UCLA School of Medicine ( Site 4006)
      • Palo Alto, California, United States, 94304
        • Stanford Health Care ( Site 4009)
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health Medical Center ( Site 4015)
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale University ( Site 4017)
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital ( Site 4005)
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Asthma and Allergy Center [Baltimore, MD] ( Site 4018)
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital ( Site 4003)
      • Boston, Massachusetts, United States, 02118
        • Boston University School of Medicine ( Site 4021)
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Hospital ( Site 4001)
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Robert Wood Johnson Medical School ( Site 4013)
    • New York
      • New York, New York, United States, 10021
        • Hospital For Special Surgery ( Site 4020)
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation ( Site 4019)
      • Toledo, Ohio, United States, 43614
        • University of Toledo Medical Center ( Site 4002)
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center ( Site 4016)
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina - PPDS ( Site 4004)
    • Texas
      • Houston, Texas, United States, 77030
        • UT Physicians Rheumatology ( Site 4007)
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert and Medical College of Wisconsin ( Site 4012)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo administered by IV infusion
Drug: Placebo
Placebo
Diagnostic test: Companion diagnostic ( CDx)
CDx+ or CDx-
Experimental: Tulisokibart
Tulisokibart IV administered by IV infusion
Drug: Tulisokibart
Tulisokibart administered at timepoints as directed by the protocol
Other Names:
  • PRA023
  • MK-7240
Diagnostic test: Companion diagnostic ( CDx)
CDx+ or CDx-

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants who Experience an Adverse Event (AE)
Time Frame: Up to Week 50
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)
Time Frame: Up to Week 50
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
Time Frame: Up to Week 50
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
Time Frame: Baseline and up to 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in FVC at Week 50
Time Frame: Baseline and 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 Week 50
Change from Baseline in High-Resolution Computer Tomography (HRCT) Quantitative Interstitial Lung Disease - Whole Lung (QILD-WL) at Week 50
Time Frame: Baseline and Week 50
QILD-WL will be measured as percent lung involvement using HRCT.
Baseline and Week 50
Percentage of Participants with an Improvement in the Revised Composite Response Index in Systemic Sclerosis (CRISS) Score at Week 50
Time Frame: Baseline and Week 50
The Revised CRISS is a two-step process designed to evaluate the likelihood of improvement in early SSc. The first step assesses worsening or incident cases of internal organ involvement (scleroderma renal crisis, pulmonary arterial hypertension, congestive heart failure, ILD, severe gastrointestinal dysmotility requiring parenteral or enteral nutrition, and digital ischemia requiring hospitalization, gangrene, or amputation). The second step assesses changes from baseline in five core set measures: modified Rodnan skin score (mRSS), percent predicted forced vital capacity (FVC%), health assessment questionnaire-disability index (HAQ-DI), patient (PGA), and physician (PhGA) global assessments.
Baseline and Week 50
Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 50
Time Frame: Baseline and Week 50
HAQ is an instrument to assess physical function. It consists of 20 questions, covering eight types of activities. For each question, scores range from 0 to 3 (0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty or with assistance; 3 = unable to do). HAQ Disability Index (HAQ-DI) score is the average of the highest score in each of the eight categories.
Baseline and Week 50
Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Quality of Life (QoL) Outcome at Week 50
Time Frame: Baseline and Week 50
The L-PF is a questionnaire designed to assess the quality of life of patients with pulmonary fibrosis. It contains 44 questions (items) split into two modules, 23 which assess symptoms (including shortness of breath, cough, and fatigue) and 21 which assess impacts to quality of life. Individual items are scored on a 5-point scale (0 = Not at All to 4 = Extremely). Overall scores range from 0 to 100 with higher scores indicating a greater impairment.
Baseline and Week 50

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Study Director: Prometheus Biosciences, Clinical Trials Call Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2022

Primary Completion (Actual)

April 16, 2026

Study Completion (Estimated)

July 31, 2029

Study Registration Dates

First Submitted

February 27, 2022

First Submitted That Met QC Criteria

March 7, 2022

First Posted (Actual)

March 8, 2022

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7240-007
  • PR200-104 (Other Identifier: PrometheusBio)
  • 2021-005206-10 (EudraCT Number)
  • MK-7240-007 (Other Identifier: MSD)
  • U1111-1309-6150 (Registry Identifier: UTN)
  • 2023-509743-27-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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