Diffuse Cutaneous Systemic SclerosisPhase 2ATHENA-SSc-ILDNCT05270668
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)
A Phase 2 study testing Tulisokibart and Companion diagnostic ( CDx) in people with Diffuse Cutaneous Systemic Sclerosis and Interstitial Lung Disease, run by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 95 sites in 20 countries.
Trial summary
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Cutaneous Systemic Sclerosis, Interstitial Lung Disease
- What is being tested?
- Tulisokibart and Companion diagnostic ( CDx)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 95 sitesin 20 countries
- Study dates
- 29 Mar 2022to 16 Nov 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
95 sites in 20 countries.
95 sites in 20 countries
United States20 sites
University of Michigan Hospital ( Site 4001)
Ann Arbor, Michigan, 48109
Johns Hopkins Asthma and Allergy Center [Baltimore, MD] ( Site 4018)
Baltimore, Maryland, 21224
Massachusetts General Hospital ( Site 4003)
Boston, Massachusetts, 02114
Boston University School of Medicine ( Site 4021)
Boston, Massachusetts, 02118
Medical University of South Carolina - PPDS ( Site 4004)
Charleston, South Carolina, 29425
Cleveland Clinic Foundation ( Site 4019)
Cleveland, Ohio, 44195
National Jewish Health Medical Center ( Site 4015)
Denver, Colorado, 80206
UT Physicians Rheumatology ( Site 4007)
Houston, Texas, 77030
Pacific Arthritis Care Center ( Site 4008)
Los Angeles, California, 90045
Cedars Sinai Medical Center ( Site 4010)
Los Angeles, California, 90048
UCLA School of Medicine ( Site 4006)
Los Angeles, California, 90095-1670
Froedtert and Medical College of Wisconsin ( Site 4012)
Milwaukee, Wisconsin, 53226
Rutgers Robert Wood Johnson Medical School ( Site 4013)
New Brunswick, New Jersey, 08901
Yale University ( Site 4017)
New Haven, Connecticut, 06519
Hospital For Special Surgery ( Site 4020)
New York, New York, 10021
Stanford Health Care ( Site 4009)
Palo Alto, California, 94304
Mayo Clinic - Scottsdale ( Site 4014)
Phoenix, Arizona, 85054
University of Pittsburgh Medical Center ( Site 4016)
Pittsburgh, Pennsylvania, 15213
University of Toledo Medical Center ( Site 4002)
Toledo, Ohio, 43614
MedStar Georgetown University Hospital ( Site 4005)
Washington D.C., District of Columbia, 20007
Spain9 sites
HOSPITAL CLÍNIC DE BARCELONA ( Site 4105)
Barcelona, Catalonia, 08036
Hospital Universitario Vall d'Hebron - PPDS ( Site 4107)
Barcelona, 08035
Hospital Santa Creu i Sant Pau ( Site 4102)
Barcelona, 08041
Hospital Universitario 12 de Octubre ( Site 4106)
Madrid, Madrid, Comunidad de, 28041
Hospital Universitario Ramon y Cajal ( Site 4101)
Madrid, 28034
Hospital Regional Universitario de Malaga ( Site 4104)
Málaga, 29009
Hospital Central de Asturias ( Site 4109)
Oviedo, Principality of Asturias, 33011
Hospital Universitario Doctor Peset ( Site 4103)
Valencia, 46017
Hospital Clinico Universitario Lozano Blesa ( Site 4100)
Zaragoza, 50009
Italy8 sites
Azienda Ospedaliera Universitaria Careggi ( Site 4301)
Florence, 50141
Ospedale Policlinico San Martino ( Site 4305)
Genova, 16132
IRCCS Osp. Maggiore Policlinico ( Site 4306)
Milan, 20122
Ospedale San Raffaele di Milano ( Site 4307)
Milan, 20132
Fondazione IRCCS Policlinico San Matteo ( Site 4303)
Pavia, 27100
Arcispedale Santa Maria Nuova ( Site 4300)
Reggio Emilia, 42123
Azienda Policlinico Umberto I ( Site 4302)
Roma, 00161
A.O.U. Citta della Salute e della Scienza di Torino ( Site 4304)
Turin, Piedmont, 10126
Poland7 sites
Uniwersytecki Szpital Kliniczny w Bialymstoku - Marii Sklodowskiej-Curie 24A ( Site 4451)
Bialystok, Podlaskie Voivodeship, 15-276
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy ( Site 4454)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168
Szpital Specjalistyczny nr 1 w Bytomiu ( Site 4453)
Bytom, Silesian Voivodeship, 41-902
Twoja Przychodnia Poznanskie Centrum Medyczne ( Site 4452)
Poznan, Greater Poland Voivodeship, 61-293
Centrum Medyczne Reuma Park NZOZ ( Site 4450)
Warsaw, Masovian Voivodeship, 02-691
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartanska 1 ( Site
Warszawa, Greater Poland Voivodeship, 02-637
Centrum Medyczne Oporow ( Site 4455)
Wroclaw, Lower Silesian Voivodeship, 52-416
Chile6 sites
BIOCINETIC Ltda ( Site 4854)
Santiago, Region M. de Santiago, 8320000
Centro de Investigacion Clinica UC CICUC ( Site 4855)
Santiago, Region M. de Santiago, 8330034
Centro Internacional de Estudios Clinicos CIEC ( Site 4851)
Santiago, Region M. de Santiago, 8420383
Centro de especialidades médicas Vanguardia ( Site 4850)
Temuco, Araucania, 4780000
ONCOCENTRO APYS ( Site 4852)
Viña del Mar, Valparaiso, 2520598
Clinica Dermacross ( Site 4853)
Vitacura, Region M. de Santiago, 7640881
Israel6 sites
Rambam Medical Center ( Site 4601)
Haifa, 3109601
Meir Medical Center. ( Site 4604)
Kfar Saba, 4428164
Galilee Medical Center ( Site 4602)
Nahariya, 2210001
Rabin Medical Center ( Site 4603)
Petach Tikvah, 49100
Sheba Medical Center ( Site 4605)
Ramat Gan, 5265601
Tel Aviv Sourasky Medical Center ( Site 4606)
Tel Aviv, 6423906
Ukraine5 sites
Kyiv City Clinical Hospital # 3 ( Site 4754)
Kyiv, Kyivska Oblast, 02125
Medical Center OK!Clinic+LLC International Institute of Clinical Research ( Site 4753)
Kyiv, 02091
Institute of Rheumatology LLC ( Site 4752)
Kyiv, 2081
ME "Ternopil Regional Clinical Hospital of Ternopil Regional Council" ( Site 4750)
Ternopil, Ternopil Oblast, 46002
Vinnytsia Nat Med University n.a.M.Pyrogov,City Clinical Hospital #1 ( Site 4751)
Vinnytsia, Vinnytsia Oblast, 21018
Argentina4 sites
Consultorios Médicos Dr. Doreski ( Site 4800)
CABA, Buenos Aires, C1426ABP
Clínica Privada Independencia ( Site 4802)
Munro, Buenos Aires, 1605
Centro de Investigación Instituto Médico Río Cuarto ( Site 4801)
Río Cuarto, Córdoba Province, 5800
Instituto Medico de la Fundacion Estudios Clinicos ( Site 4803)
Rosario, Santa Fe Province, S2000CEJ
Germany4 sites
Kerckhoff-Klinik-Forschungs-GmbH ( Site 4153)
Bad Nauheim, Hesse, 61231
Universitaetsklinikum Koeln ( Site 4151)
Cologne, North Rhine-Westphalia, 50937
Universitaetsklinikum Freiburg ( Site 4152)
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Rheumazentrum am Krankenhaus Bad Doberan ( Site 4150)
Hohenfelde B Bad Doberan, Mecklenburg-Vorpommern, 18209
Hungary4 sites
Budai Irgalmasrendi Korhaz ( Site 4252)
Budapest, 1023
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet ( Site 4253)
Budapest, 1097
Debreceni Egyetem Klinikai Kozpont ( Site 4251)
Debrecen, 4032
Pecsi Tudomanyegyetem AOK ( Site 4250)
Pécs, Baranya, 7632
Switzerland4 sites
Inselspital Bern ( Site 4502)
Bern, Canton of Bern, 3010
Hopitaux Universitaires de Geneve HUG ( Site 4503)
Geneva, 1211
Kantonsspital St. Gallen ( Site 4501)
Sankt Gallen, Canton of St. Gallen, 9007
Universitaetsspital Zuerich ( Site 4500)
Zurich, 8091
Belgium3 sites
UZ Gent ( Site 4401)
Ghent, Oost-Vlaanderen, 9000
UZ Leuven ( Site 4402)
Leuven, Vlaams-Brabant, 3000
CHU de Liege ( Site 4400)
Liège, Wallonne, Region, 4000
Canada3 sites
University Of Alberta Hospital ( Site 4702)
Edmonton, Alberta, T6G 1W9
St. Joseph's Health Care London ( Site 4701)
London, Ontario, N6A 4V2
Mount Sinai Hospital [Toronto, Canada] ( Site 4700)
Toronto, Ontario, M5T 3L9
France3 sites
CHU de Bordeaux. Hopital Pellegrin ( Site 4202)
Bordeaux, Nord, 33076
Hôpital Claude Huriez ( Site 4200)
Lille, Nord, 59000
Hopital Cochin ( Site 4203)
Paris, 75679
Australia2 sites
Royal Adelaide Hospital ( Site 4050)
Adelaide, South Australia, 5000
St Vincents Hospital Melbourne ( Site 4051)
Melbourne, Victoria, 3065
Mexico2 sites
PanAmerican Clinical Research - Guadalajara ( Site 4900)
Guadalajara, Jalisco, 44670
Centro de Investigación y Tratamiento Reumatológico S.C ( Site 4902)
Mexico City, Mexico City, 31000
United Kingdom2 sites
Chapel Allerton Hospital ( Site 4551)
Leeds, LS7 4SA
Royal Free Hospital ( Site 4550)
London, London, City of, NW3 2QG
Netherlands1 site
Radboud University Medical Center ( Site 4650)
Nijmegen, Gelderland, 6500 HB
Norway1 site
Oslo Universitetssykehus HF. Rikshospitalet ( Site 4350)
Oslo, 0372
About this study
Official title: 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.
- Being tested
- Tulisokibart, Companion diagnostic ( CDx), Placebo
- Keywords
- ATHENA SSc-ILD, ATHENA, Diffuse Cutaneous Scleroderma, Interstitial Lung Disease
- Medical subject headings
- Scleroderma, Diffuse, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TulisokibartDrug
Also called PRA023, MK-7240
Tulisokibart administered at timepoints as directed by the protocol
Companion diagnostic ( CDx)Diagnostic test
CDx+ or CDx-
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Tulisokibart | Experimental | Tulisokibart IV administered by IV infusion Receives: Drug: Tulisokibart; Diagnostic Test: Companion diagnostic ( CDx) |
| Placebo | Placebo comparator | Placebo administered by IV infusion Receives: Diagnostic Test: Companion diagnostic ( CDx); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and up to Week 50
Secondary outcomes (5)
Change from Baseline in 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.
Measured: Baseline and Week 50
Change from Baseline in High-Resolution Computer Tomography (HRCT) Quantitative Interstitial Lung Disease - Whole Lung (QILD-WL) at Week 50
QILD-WL will be measured as percent lung involvement using HRCT.
Measured: Baseline and Week 50
Percentage of Participants with an Improvement in the Revised Composite Response Index in Systemic Sclerosis (CRISS) Score at 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.
Measured: Baseline and Week 50
Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at 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.
Measured: Baseline and Week 50
Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Quality of Life (QoL) Outcome at 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.
Measured: Baseline and Week 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start29 Mar 2022
- Primary completion16 Apr 2026
- Study completion16 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Cutaneous Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prometheus Biosciences, Study director, Clinical Trials Call Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270668
- Sponsor's protocol ID
- 7240-007
- Other IDs
- PR200-104, MK-7240-007, 2023-509743-27-00, U1111-1309-6150, 2021-005206-10, 2023
- Acronym
- ATHENA-SSc-ILD
- Status last verified
- Sep 2026
- First submitted
- 27 Feb 2022
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf