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)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

154

Participants

Timeline

Start Date

March 29, 2022

Primary Completion Date

April 30, 2026

Study Completion Date

July 31, 2029

Conditions
Diffuse Cutaneous Systemic SclerosisInterstitial Lung Disease
Interventions
DRUG

Tulisokibart

Tulisokibart administered at timepoints as directed by the protocol

DIAGNOSTIC_TEST

Companion diagnostic ( CDx)

CDx+ or CDx-

DRUG

Placebo

Placebo

Trial Locations (95)

1023

Budai Irgalmasrendi Korhaz ( Site 4252), Budapest

1097

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

1211

Hopitaux Universitaires de Geneve HUG ( Site 4503), Geneva

1605

Clínica Privada Independencia ( Site 4802), Munro

2081

Institute of Rheumatology LLC ( Site 4752), Kyiv

3000

UZ Leuven ( Site 4402), Leuven

3010

Inselspital Bern ( Site 4502), Bern

3065

St Vincents Hospital Melbourne ( Site 4051), Melbourne

4000

CHU de Liege ( Site 4400), Liège

4032

Debreceni Egyetem Klinikai Kozpont ( Site 4251), Debrecen

5000

Royal Adelaide Hospital ( Site 4050), Adelaide

5800

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

7632

Pecsi Tudomanyegyetem AOK ( Site 4250), Pécs

8091

Universitaetsspital Zuerich ( Site 4500), Zurich

9000

UZ Gent ( Site 4401), Ghent

9007

Kantonsspital St. Gallen ( Site 4501), Sankt Gallen

10021

Hospital For Special Surgery ( Site 4020), New York

10126

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

15023

Instituto de Ginecologia y Reproduccion ( Site 4952), Lima

15213

University of Pittsburgh Medical Center ( Site 4016), Pittsburgh

16132

Ospedale Policlinico San Martino ( Site 4305), Genova

18209

Rheumazentrum am Krankenhaus Bad Doberan ( Site 4150), Hohenfelde B Bad Doberan

20007

MedStar Georgetown University Hospital ( Site 4005), Washington D.C.

20122

IRCCS Osp. Maggiore Policlinico ( Site 4306), Milan

20132

Ospedale San Raffaele di Milano ( Site 4307), Milan

21018

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

21224

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

27100

Fondazione IRCCS Policlinico San Matteo ( Site 4303), Pavia

28034

Hospital Universitario Ramon y Cajal ( Site 4101), Madrid

28041

Hospital Universitario 12 de Octubre ( Site 4106), Madrid

29009

Hospital Regional Universitario de Malaga ( Site 4104), Málaga

29425

Medical University of South Carolina - PPDS ( Site 4004), Charleston

31000

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

33011

Hospital Central de Asturias ( Site 4109), Oviedo

33076

CHU de Bordeaux. Hopital Pellegrin ( Site 4202), Bordeaux

42123

Arcispedale Santa Maria Nuova ( Site 4300), Reggio Emilia

43614

University of Toledo Medical Center ( Site 4002), Toledo

44195

Cleveland Clinic Foundation ( Site 4019), Cleveland

44670

PanAmerican Clinical Research - Guadalajara ( Site 4900), Guadalajara

46002

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

46017

Hospital Universitario Doctor Peset ( Site 4103), Valencia

48109

University of Michigan Hospital ( Site 4001), Ann Arbor

49100

Rabin Medical Center ( Site 4603), Petach Tikvah

50009

Hospital Clinico Universitario Lozano Blesa ( Site 4100), Zaragoza

50141

Azienda Ospedaliera Universitaria Careggi ( Site 4301), Florence

50937

Universitaetsklinikum Koeln ( Site 4151), Cologne

53226

Froedtert and Medical College of Wisconsin ( Site 4012), Milwaukee

59000

Hôpital Claude Huriez ( Site 4200), Lille

61231

Kerckhoff-Klinik-Forschungs-GmbH ( Site 4153), Bad Nauheim

75679

Hopital Cochin ( Site 4203), Paris

77030

UT Physicians Rheumatology ( Site 4007), Houston

79106

Universitaetsklinikum Freiburg ( Site 4152), Freiburg im Breisgau

80206

National Jewish Health Medical Center ( Site 4015), Denver

85054

Mayo Clinic - Scottsdale ( Site 4014), Phoenix

90045

Pacific Arthritis Care Center ( Site 4008), Los Angeles

90048

Cedars Sinai Medical Center ( Site 4010), Los Angeles

94304

Stanford Health Care ( Site 4009), Palo Alto

2210001

Galilee Medical Center ( Site 4602), Nahariya

2520598

ONCOCENTRO APYS ( Site 4852), Viña del Mar

3109601

Rambam Medical Center ( Site 4601), Haifa

4428164

Meir Medical Center. ( Site 4604), Kfar Saba

4780000

Centro de especialidades médicas Vanguardia ( Site 4850), Temuco

5265601

Sheba Medical Center ( Site 4605), Ramat Gan

6423906

Tel Aviv Sourasky Medical Center ( Site 4606), Tel Aviv

7640881

Clinica Dermacross ( Site 4853), Vitacura

8320000

BIOCINETIC Ltda ( Site 4854), Santiago

8330034

Centro de Investigacion Clinica UC CICUC ( Site 4855), Santiago

8420383

Centro Internacional de Estudios Clinicos CIEC ( Site 4851), Santiago

90095-1670

UCLA School of Medicine ( Site 4006), Los Angeles

06519

Yale University ( Site 4017), New Haven

02114

Massachusetts General Hospital ( Site 4003), Boston

02118

Boston University School of Medicine ( Site 4021), Boston

08901

Rutgers Robert Wood Johnson Medical School ( Site 4013), New Brunswick

C1426ABP

Consultorios Médicos Dr. Doreski ( Site 4800), CABA

S2000CEJ

Instituto Medico de la Fundacion Estudios Clinicos ( Site 4803), Rosario

T6G 1W9

University Of Alberta Hospital ( Site 4702), Edmonton

N6A 4V2

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

M5T 3L9

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

00161

Azienda Policlinico Umberto I ( Site 4302), Roma

6500 HB

Radboud University Medical Center ( Site 4650), Nijmegen

0372

Oslo Universitetssykehus HF. Rikshospitalet ( Site 4350), Oslo

61-293

Twoja Przychodnia Poznanskie Centrum Medyczne ( Site 4452), Poznan

02-637

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

85-168

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

52-416

Centrum Medyczne Oporow ( Site 4455), Wroclaw

02-691

Centrum Medyczne Reuma Park NZOZ ( Site 4450), Warsaw

15-276

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

41-902

Szpital Specjalistyczny nr 1 w Bytomiu ( Site 4453), Bytom

08036

HOSPITAL CLÍNIC DE BARCELONA ( Site 4105), Barcelona

08035

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

08041

Hospital Santa Creu i Sant Pau ( Site 4102), Barcelona

02125

Kyiv City Clinical Hospital # 3 ( Site 4754), Kyiv

02091

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

NW3 2QG

Royal Free Hospital ( Site 4550), London

LS7 4SA

Chapel Allerton Hospital ( Site 4551), Leeds

All Listed Sponsors
lead

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

INDUSTRY