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)
Who is this study for? Patients with systemic sclerosis associated with interstitial lung disease
What treatments are being studied? PRA023
Status: Active_not_recruiting
Location: See all (95) locations...
Intervention Type: Drug, Diagnostic test
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Mayo Clinic - Scottsdale ( Site 4014)
Phoenix
California
Cedars Sinai Medical Center ( Site 4010)
Los Angeles
Pacific Arthritis Care Center ( Site 4008)
Los Angeles
UCLA School of Medicine ( Site 4006)
Los Angeles
Stanford Health Care ( Site 4009)
Palo Alto
Colorado
National Jewish Health Medical Center ( Site 4015)
Denver
Connecticut
Yale University ( Site 4017)
New Haven
Washington, D.c.
MedStar Georgetown University Hospital ( Site 4005)
Washington D.c.
Massachusetts
Boston University School of Medicine ( Site 4021)
Boston
Massachusetts General Hospital ( Site 4003)
Boston
Maryland
Johns Hopkins Asthma and Allergy Center [Baltimore, MD] ( Site 4018)
Baltimore
Michigan
University of Michigan Hospital ( Site 4001)
Ann Arbor
New Jersey
Rutgers Robert Wood Johnson Medical School ( Site 4013)
New Brunswick
New York
Hospital For Special Surgery ( Site 4020)
New York
Ohio
Cleveland Clinic Foundation ( Site 4019)
Cleveland
University of Toledo Medical Center ( Site 4002)
Toledo
Pennsylvania
University of Pittsburgh Medical Center ( Site 4016)
Pittsburgh
South Carolina
Medical University of South Carolina - PPDS ( Site 4004)
Charleston
Texas
UT Physicians Rheumatology ( Site 4007)
Houston
Wisconsin
Froedtert and Medical College of Wisconsin ( Site 4012)
Milwaukee
Other Locations
Argentina
Consultorios Médicos Dr. Doreski ( Site 4800)
Caba
Clínica Privada Independencia ( Site 4802)
Munro
Centro de Investigación Instituto Médico Río Cuarto ( Site 4801)
Río Cuarto
Instituto Medico de la Fundacion Estudios Clinicos ( Site 4803)
Rosario
Australia
Royal Adelaide Hospital ( Site 4050)
Adelaide
St Vincents Hospital Melbourne ( Site 4051)
Melbourne
Belgium
UZ Gent ( Site 4401)
Ghent
UZ Leuven ( Site 4402)
Leuven
CHU de Liege ( Site 4400)
Liège
Canada
University Of Alberta Hospital ( Site 4702)
Edmonton
St. Joseph's Health Care London ( Site 4701)
London
Mount Sinai Hospital [Toronto, Canada] ( Site 4700)
Toronto
Chile
BIOCINETIC Ltda ( Site 4854)
Santiago
Centro de Investigacion Clinica UC CICUC ( Site 4855)
Santiago
Centro Internacional de Estudios Clinicos CIEC ( Site 4851)
Santiago
Centro de especialidades médicas Vanguardia ( Site 4850)
Temuco
ONCOCENTRO APYS ( Site 4852)
Viña Del Mar
Clinica Dermacross ( Site 4853)
Vitacura
France
CHU de Bordeaux. Hopital Pellegrin ( Site 4202)
Bordeaux
Hôpital Claude Huriez ( Site 4200)
Lille
Hopital Cochin ( Site 4203)
Paris
Germany
Kerckhoff-Klinik-Forschungs-GmbH ( Site 4153)
Bad Nauheim
Universitaetsklinikum Koeln ( Site 4151)
Cologne
Universitaetsklinikum Freiburg ( Site 4152)
Freiburg Im Breisgau
Rheumazentrum am Krankenhaus Bad Doberan ( Site 4150)
Hohenfelde B Bad Doberan
Hungary
Budai Irgalmasrendi Korhaz ( Site 4252)
Budapest
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet ( Site 4253)
Budapest
Debreceni Egyetem Klinikai Kozpont ( Site 4251)
Debrecen
Pecsi Tudomanyegyetem AOK ( Site 4250)
Pécs
Israel
Rambam Medical Center ( Site 4601)
Haifa
Meir Medical Center. ( Site 4604)
Kfar Saba
Galilee Medical Center ( Site 4602)
Nahariya
Rabin Medical Center ( Site 4603)
Petach Tikvah
Sheba Medical Center ( Site 4605)
Ramat Gan
Tel Aviv Sourasky Medical Center ( Site 4606)
Tel Aviv
Italy
Azienda Ospedaliera Universitaria Careggi ( Site 4301)
Florence
Ospedale Policlinico San Martino ( Site 4305)
Genova
IRCCS Osp. Maggiore Policlinico ( Site 4306)
Milan
Ospedale San Raffaele di Milano ( Site 4307)
Milan
Fondazione IRCCS Policlinico San Matteo ( Site 4303)
Pavia
Arcispedale Santa Maria Nuova ( Site 4300)
Reggio Emilia
Azienda Policlinico Umberto I ( Site 4302)
Roma
A.O.U. Citta della Salute e della Scienza di Torino ( Site 4304)
Turin
Mexico
PanAmerican Clinical Research - Guadalajara ( Site 4900)
Guadalajara
Centro de Investigación y Tratamiento Reumatológico S.C ( Site 4902)
Mexico City
Netherlands
Radboud University Medical Center ( Site 4650)
Nijmegen
Norway
Oslo Universitetssykehus HF. Rikshospitalet ( Site 4350)
Oslo
Peru
Instituto de Ginecologia y Reproduccion ( Site 4952)
Lima
Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku - Marii Sklodowskiej-Curie 24A ( Site 4451)
Bialystok
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy ( Site 4454)
Bydgoszcz
Szpital Specjalistyczny nr 1 w Bytomiu ( Site 4453)
Bytom
Twoja Przychodnia Poznanskie Centrum Medyczne ( Site 4452)
Poznan
Centrum Medyczne Reuma Park NZOZ ( Site 4450)
Warsaw
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartanska 1 ( Site
Warszawa
Centrum Medyczne Oporow ( Site 4455)
Wroclaw
Spain
HOSPITAL CLÍNIC DE BARCELONA ( Site 4105)
Barcelona
Hospital Santa Creu i Sant Pau ( Site 4102)
Barcelona
Hospital Universitario Vall d'Hebron - PPDS ( Site 4107)
Barcelona
Hospital Universitario 12 de Octubre ( Site 4106)
Madrid
Hospital Universitario Ramon y Cajal ( Site 4101)
Madrid
Hospital Regional Universitario de Malaga ( Site 4104)
Málaga
Hospital Central de Asturias ( Site 4109)
Oviedo
Hospital Universitario Doctor Peset ( Site 4103)
Valencia
Hospital Clinico Universitario Lozano Blesa ( Site 4100)
Zaragoza
Switzerland
Inselspital Bern ( Site 4502)
Bern
Hopitaux Universitaires de Geneve HUG ( Site 4503)
Geneva
Kantonsspital St. Gallen ( Site 4501)
Sankt Gallen
Universitaetsspital Zuerich ( Site 4500)
Zurich
Ukraine
Institute of Rheumatology LLC ( Site 4752)
Kyiv
Kyiv City Clinical Hospital # 3 ( Site 4754)
Kyiv
Medical Center OK!Clinic+LLC International Institute of Clinical Research ( Site 4753)
Kyiv
ME Ternopil Regional Clinical Hospital of Ternopil Regional Council ( Site 4750)
Ternopil
Vinnytsia Nat Med University n.a.M.Pyrogov,City Clinical Hospital #1 ( Site 4751)
Vinnytsia
United Kingdom
Chapel Allerton Hospital ( Site 4551)
Leeds
Royal Free Hospital ( Site 4550)
London
Time Frame
Start Date: 2022-03-29
Completion Date: 2029-07-31
Participants
Target number of participants: 154
Treatments
Experimental: Tulisokibart
Tulisokibart IV administered by IV infusion
Placebo_comparator: Placebo
Placebo administered by IV infusion
Related Therapeutic Areas
Sponsors
Leads: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)