Phase
Condition
Lung Disease
Scar Tissue
Treatment
Placebo
PRA023 IV
Companion diagnostic ( CDx)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 orbreastfeeding and either willing to use an acceptable contraceptive method orsexually abstinent
Able to provide written informed consent and understand and comply with therequirements of the study
Exclusion
Exclusion Criteria:
Has an airway obstruction per pulmonary function test (PFT) or clinicallysignificant 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 chronicbacterial 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 Design
Connect with a study center
Consultorios Médicos Dr. Doreski ( Site 4800)
Caba, Buenos Aires C1426ABP
ArgentinaSite Not Available
Clínica Privada Independencia ( Site 4802)
Munro, Buenos Aires 1605
ArgentinaSite Not Available
Centro de Investigación Instituto Médico Río Cuarto ( Site 4801)
Rio Cuarto, Cordoba 5800
ArgentinaSite Not Available
Instituto Medico de la Fundacion Estudios Clinicos ( Site 4803)
Rosario, Santa Fe S2000DEJ
ArgentinaSite Not Available
Instituto Medico de la Fundacion Estudios Clinicos ( Site 4803)
Rosario., Santa Fe S2000CEJ
ArgentinaSite Not Available
Prometheus Biosciences Selected Site
Adelaide, South Australia 5000
AustraliaActive - Recruiting
Royal Adelaide Hospital ( Site 4050)
Adelaide, South Australia 5000
AustraliaSite Not Available
Prometheus Biosciences Selected Site
Fitzroy, Victoria
AustraliaSite Not Available
St Vincents Hospital Melbourne ( Site 4051)
Melbourne, Victoria 3065
AustraliaSite Not Available
CHU de Liege ( Site 4400)
Luik, Liege 4000
BelgiumSite Not Available
Prometheus Biosciences Selected Site
Gent, Oost-Vlaanderen 9000
BelgiumActive - Recruiting
UZ Gent ( Site 4401)
Gent, Oost-Vlaanderen 9000
BelgiumSite Not Available
Prometheus Biosciences Selected Center
Leuven, Vlaams Brabant 3000
BelgiumActive - Recruiting
UZ Leuven ( Site 4402)
Leuven, Vlaams-Brabant 3000
BelgiumSite Not Available
CHU de Liege ( Site 4400)
Liège, Wallonne, Region 4000
BelgiumSite Not Available
CHU de Liege ( Site 4400)
Liege, 4000
BelgiumSite Not Available
Prometheus Biosciences Selected Site
Liège, 4000
BelgiumSite Not Available
Prometheus Biosciences Call Center
Edmonton, Alberta T6G 2C8
CanadaActive - Recruiting
University Of Alberta Hospital ( Site 4702)
Edmonton, Alberta T6G 1W9
CanadaSite Not Available
Prometheus Biosciences Selected Site
London, Ontario N6A 4V2
CanadaActive - Recruiting
St. Joseph's Health Care London ( Site 4701)
London, Ontario N6A 4V2
CanadaSite Not Available
Mount Sinai Hospital [Toronto, Canada] ( Site 4700)
Toronto, Ontario M5T 3L9
CanadaSite Not Available
Prometheus Biosciences Selected Site
Toronto, Ontario M5T 3L9
CanadaActive - Recruiting
Centro de especialidades médicas Vanguardia ( Site 4850)
Temuco, Araucania 4780000
ChileSite Not Available
BIOCINETIC Ltda ( Site 4854)
Santiago, Region M. De Santiago 8320000
ChileSite Not Available
Centro Internacional de Estudios Clinicos CIEC ( Site 4851)
Santiago, Region M. De Santiago 8420383
ChileSite Not Available
Centro de Investigacion Clinica UC CICUC ( Site 4855)
Santiago, Region M. De Santiago 8330034
ChileSite Not Available
Clinica Dermacross ( Site 4853)
Vitacura, Region M. De Santiago 7640881
ChileSite Not Available
ONCOCENTRO APYS ( Site 4852)
Vina del Mar, Valparaiso 2520598
ChileSite Not Available
ONCOCENTRO APYS ( Site 4852)
Viña del Mar, Valparaiso 2520598
ChileSite Not Available
Prometheus Biosciences Selected Site
Bordeaux, Gironde 33076
FranceActive - Recruiting
CHU de Bordeaux. Hopital Pellegrin ( Site 4202)
Bordeaux, Nord 33076
FranceSite Not Available
Hôpital Claude Huriez ( Site 4200)
Lille, Nord 59000
FranceSite Not Available
Prometheus Biosciences Selected Site
Lille, Nord 59000
FranceActive - Recruiting
Hopital Cochin ( Site 4203)
Paris, 75679
FranceSite Not Available
Prometheus Biosciences Selected Site
Paris, 75014
FranceActive - Recruiting
Universitaetsklinikum Freiburg ( Site 4152)
Freiburg, Baden-Wurttemberg 79106
GermanySite Not Available
Kerckhoff-Klinik-Forschungs-GmbH ( Site 4153)
Bad Nauheim, Hessen 61231
GermanySite Not Available
Prometheus Biosciences Selected Site
Bad Nauheim, Hessen 61231
GermanyActive - Recruiting
Rheumazentrum am Krankenhaus Bad Doberan ( Site 4150)
Hohenfelde B Bad Doberan, Mecklenburg-Vorpommern 18209
GermanySite Not Available
Prometheus Biosciences Selected Site
Köln, Nordrhein-Westfalen 50931
GermanyActive - Recruiting
Universitaetsklinikum Koeln ( Site 4151)
Köln, Nordrhein-Westfalen 50937
GermanySite Not Available
Prometheus Biosciences Selected Site
Bad Doberan, 18209
GermanySite Not Available
Prometheus Biosciences Selected Site
Freiburg, 79106
GermanyActive - Recruiting
Pecsi Tudomanyegyetem AOK ( Site 4250)
Pecs, Baranya 7632
HungarySite Not Available
Prometheus Biosciences Selected Site
Pécs, Baranya 7632
HungarySite Not Available
Prometheus Biosciences Selected Site
Debrecen, Hajdu-Bihar 4032
HungaryActive - Recruiting
Budai Irgalmasrendi Korhaz ( Site 4252)
Budapest, 1023
HungarySite Not Available
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet ( Site 4253)
Budapest, 1097
HungarySite Not Available
Prometheus Biosciences Selected Site
Budapest, 1121
HungaryActive - Recruiting
Debreceni Egyetem Klinikai Kozpont ( Site 4251)
Debrecen, 4032
HungarySite Not Available
Prometheus Biosciences Selected Site
Kfar Saba, HaMerkas 44281
IsraelActive - Recruiting
Prometheus Biosciences Call Center
Nahariya, HaZafon 2210001
IsraelActive - Recruiting
Prometheus Biosciences Selected Site
Ramat Gan, Tel-Aviv 52621
IsraelSite Not Available
Prometheus Biosciences Selected Site
Haifa, 31096
IsraelActive - Recruiting
Rambam Medical Center ( Site 4601)
Haifa, 3109601
IsraelSite Not Available
Meir Medical Center ( Site 4604)
Kfar Saba, 4428164
IsraelActive - Recruiting
Meir Medical Center. ( Site 4604)
Kfar Saba, 4428164
IsraelSite Not Available
Galilee Medical Center ( Site 4602)
Nahariya, 2210001
IsraelSite Not Available
Rabin Medical Center ( Site 4603)
Petach Tikvah, 49100
IsraelSite Not Available
Prometheus Biosciences Selected Site
Petah tikva, 49100
IsraelSite Not Available
Sheba Medical Center ( Site 4605)
Ramat-Gan, 5265601
IsraelSite Not Available
Prometheus Biosciences Selected Site
Tel Aviv, 64239
IsraelActive - Recruiting
Tel Aviv Sourasky Medical Center ( Site 4606)
Tel Aviv, 6423906
IsraelSite Not Available
Prometheus Biosciences Selected Site
Reggio Emilia, Emilia-Romagne 42123
ItalyActive - Recruiting
Prometheus Biosciences Selected Site
Roma, Lazio 00161
ItalyActive - Recruiting
Prometheus Biosciences Selected Site
Genova, Liguria 16132
ItalyActive - Recruiting
Prometheus Biosciences Selected Site
Pavia, Lombardia 27100
ItalyActive - Recruiting
A.O.U. Citta della Salute e della Scienza di Torino ( Site 4304)
Torino, Piemonte 10126
ItalySite Not Available
Prometheus Biosciences Selected Site
Firenze, Toscana 50139
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Careggi ( Site 4301)
Firenze, 50141
ItalySite Not Available
Ospedale Policlinico San Martino ( Site 4305)
Genova, 16132
ItalySite Not Available
IRCCS Osp. Maggiore Policlinico ( Site 4306)
Milano, 20122
ItalySite Not Available
Ospedale San Raffaele di Milano ( Site 4307)
Milano, 20132
ItalySite Not Available
Fondazione IRCCS Policlinico San Matteo ( Site 4303)
Pavia, 27100
ItalySite Not Available
Arcispedale Santa Maria Nuova ( Site 4300)
Reggio Emilia, 42123
ItalySite Not Available
Azienda Policlinico Umberto I ( Site 4302)
Roma, 00161
ItalySite Not Available
Centro de Investigación y Tratamiento Reumatológico S.C ( Site 4902)
Ciudad de México, Distrito Federal 31000
MexicoSite Not Available
PanAmerican Clinical Research - Guadalajara ( Site 4900)
Guadalajara, Jalisco 44670
MexicoSite Not Available
Prometheus Biosciences Selected Site
Nijmegen, Gelderland 6525 GA
NetherlandsActive - Recruiting
Radboud University Medical Center ( Site 4650)
Nijmegen, Gelderland 6500 HB
NetherlandsSite Not Available
Oslo Universitetssykehus HF. Rikshospitalet ( Site 4350)
Oslo, 0372
NorwaySite Not Available
Prometheus Biosciences Selected Site
Oslo, N-0372
NorwayActive - Recruiting
Instituto de Ginecologia y Reproduccion ( Site 4952)
Lima, 15023
PeruSite Not Available
Centrum Medyczne Oporow ( Site 4455)
Wroclaw, Dolnoslaskie 52-416
PolandSite Not Available
Prometheus Biosciences Selected Site
Wrocław, Dolnoslaskie 53-439
PolandSite Not Available
Prometheus Biosciences Selected Site
Bydgoszcz, Kujawsko-pomorskie 85-168
PolandActive - Recruiting
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy ( Site 4454)
Bydgoszcz, Kujawsko-pomorskie 85-168
PolandSite Not Available
Centrum Medyczne Reuma Park NZOZ ( Site 4450)
Warszawa, Mazowieckie 02-691
PolandSite Not Available
Prometheus Biosciences Selected Site
Warszawa, Mazowieckie 02-665
PolandActive - Recruiting
Prometheus Biosciences Selected Site
Białystok, Podlaskie 15-276
PolandActive - Recruiting
Uniwersytecki Szpital Kliniczny w Bialymstoku - Marii Sklodowskiej-Curie 24A ( Site 4451)
Białystok, Podlaskie 15-276
PolandSite Not Available
Prometheus Biosciences Selected Site
Bytom, Slaskie 41-902
PolandActive - Recruiting
Szpital Specjalistyczny nr 1 w Bytomiu ( Site 4453)
Bytom, Slaskie 41-902
PolandSite Not Available
Prometheus Biosciences Call Center
Poznań, Wielkopolski 61-293
PolandActive - Recruiting
Twoja Przychodnia Poznanskie Centrum Medyczne ( Site 4452)
Poznań, Wielkopolskie 61-293
PolandSite Not Available
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartanska 1 ( Site
Warszawa, Wielkopolskie 02-637
PolandSite Not Available
Hospital Central de Asturias ( Site 4109)
Oviedo, Asturias 33011
SpainSite Not Available
HOSPITAL CLÍNIC DE BARCELONA ( Site 4105)
Barcelona, Cataluna 08036
SpainSite Not Available
Hospital Universitario 12 de Octubre ( Site 4106)
Madrid, Madrid, Comunidad De 28041
SpainSite Not Available
Prometheus Biosciences Selected Site
Málaga, Malaga 29009
SpainSite Not Available
Hospital Santa Creu i Sant Pau ( Site 4102)
Barcelona, 08041
SpainSite Not Available
Hospital Universitario Vall d'Hebron - PPDS ( Site 4107)
Barcelona, 08035
SpainSite Not Available
Prometheus Biosciences Selected Site
Barcelona, 08035
SpainActive - Recruiting
Hospital Universitario Ramon y Cajal ( Site 4101)
Madrid, 28034
SpainSite Not Available
Prometheus Biosciences Selected Site
Madrid, 28034
SpainActive - Recruiting
Hospital Regional Universitario de Malaga ( Site 4104)
Malaga, 29009
SpainSite Not Available
Hospital Universitario Doctor Peset ( Site 4103)
Valencia, 46017
SpainSite Not Available
Prometheus Biosciences Selected Site
Valencia, 46017
SpainActive - Recruiting
Hospital Clinico Universitario Lozano Blesa ( Site 4100)
Zaragoza, 50009
SpainSite Not Available
Prometheus Biosciences Selected Site
Zaragoza, 50009
SpainActive - Recruiting
Inselspital Bern ( Site 4502)
Bern, Berne 3010
SwitzerlandSite Not Available
Kantonsspital St. Gallen ( Site 4501)
St. Gallen, Sankt Gallen 9007
SwitzerlandSite Not Available
Prometheus Biosciences Selected Site
Saint Gallen, Sankt Gallen (de) 9007
SwitzerlandSite Not Available
Prometheus Biosciences Selected Site
Zürich, Zurich 8091
SwitzerlandSite Not Available
Prometheus Biosciences Selected Site
Bern, 3010
SwitzerlandActive - Recruiting
Prometheus Biosciences Selected Site
Geneva, 1206
SwitzerlandSite Not Available
Hopitaux Universitaires de Geneve HUG ( Site 4503)
Geneve, 1211
SwitzerlandSite Not Available
Universitaetsspital Zuerich ( Site 4500)
Zurich, 8091
SwitzerlandSite Not Available
Kyiv City Clinical Hospital # 3 ( Site 4754)
Kyiv, Kyivska Oblast 02125
UkraineSite Not Available
ME "Ternopil Regional Clinical Hospital of Ternopil Regional Council" ( Site 4750)
Ternopil, Ternopilska Oblast 46002
UkraineSite Not Available
Vinnytsia Nat Med University n.a.M.Pyrogov,City Clinical Hospital #1 ( Site 4751)
Vinnytsia, Vinnytska Oblast 21018
UkraineSite Not Available
Institute of Rheumatology LLC ( Site 4752)
Kyiv, 2081
UkraineSite Not Available
Medical Center OK!Clinic+LLC International Institute of Clinical Research ( Site 4753)
Kyiv, 02091
UkraineSite Not Available
Royal Free Hospital ( Site 4550)
London, London, City Of NW3 2QG
United KingdomSite Not Available
Prometheus Biosciences Selected Site
Leeds, West Yorkshire LS1 3EX
United KingdomActive - Recruiting
Chapel Allerton Hospital ( Site 4551)
Leeds, LS7 4SA
United KingdomSite Not Available
Prometheus Biosciences Selected Site
London, NW3 2QG
United KingdomActive - Recruiting
Mayo Clinic - Scottsdale ( Site 4014)
Phoenix, Arizona 85054
United StatesSite Not Available
Prometheus Biosciences Selected Site
Scottsdale, Arizona 85259
United StatesSite Not Available
Cedars Sinai Medical Center ( Site 4010)
Los Angeles, California 90048
United StatesSite Not Available
Pacific Arthritis Care Center ( Site 4008)
Los Angeles, California 90045
United StatesSite Not Available
Prometheus Biosciences Selected Site
Los Angeles, California 90095
United StatesActive - Recruiting
UCLA School of Medicine ( Site 4006)
Los Angeles, California 90095-1670
United StatesSite Not Available
Prometheus Biosciences Selected Site
Palo Alto, California 94304
United StatesActive - Recruiting
Stanford Health Care ( Site 4009)
Palo Alto, California 94304
United StatesSite Not Available
National Jewish Health Medical Center ( Site 4015)
Denver, Colorado 80206
United StatesSite Not Available
Prometheus Biosciences Selected Site
Denver, Colorado 80206
United StatesActive - Recruiting
Prometheus Biosciences Selected Site
New Haven, Connecticut 06519
United StatesActive - Recruiting
Yale University ( Site 4017)
New Haven, Connecticut 06519
United StatesSite Not Available
MedStar Georgetown University Hospital ( Site 4005)
Washington, District of Columbia 20007
United StatesSite Not Available
Prometheus Biosciences Selected Site
Washington, District of Columbia 20007
United StatesActive - Recruiting
Johns Hopkins Asthma and Allergy Center [Baltimore, MD] ( Site 4018)
Baltimore, Maryland 21224
United StatesSite Not Available
Prometheus Biosciences Selected Site
Baltimore, Maryland 21224-6821
United StatesActive - Recruiting
Boston University School of Medicine ( Site 4021)
Boston, Massachusetts 02118
United StatesSite Not Available
Massachusetts General Hospital ( Site 4003)
Boston, Massachusetts 02114
United StatesSite Not Available
Prometheus Biosciences Selected Site
Boston, Massachusetts 02118
United StatesActive - Recruiting
Prometheus Biosciences Selected Site
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
University of Michigan Hospital ( Site 4001)
Ann Arbor, Michigan 48109
United StatesSite Not Available
Prometheus Biosciences Selected Site
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
Rutgers Robert Wood Johnson Medical School ( Site 4013)
New Brunswick, New Jersey 08901
United StatesSite Not Available
Hospital For Special Surgery ( Site 4020)
New York, New York 10021
United StatesSite Not Available
Prometheus Biosciences Selected Site
New York, New York 10021-4823
United StatesActive - Recruiting
Cleveland Clinic Foundation ( Site 4019)
Cleveland, Ohio 44195
United StatesSite Not Available
Prometheus Biosciences Selected Site
Cleveland, Ohio 44195
United StatesActive - Recruiting
Prometheus Biosciences Selected Site
Toledo, Ohio 43614
United StatesActive - Recruiting
University of Toledo Medical Center ( Site 4002)
Toledo, Ohio 43614
United StatesSite Not Available
Prometheus Biosciences Selected Site
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting
University of Pittsburgh Medical Center ( Site 4016)
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Medical University of South Carolina - PPDS ( Site 4004)
Charleston, South Carolina 29425
United StatesSite Not Available
Prometheus Biosciences Selected Site
Charleston, South Carolina 29425
United StatesActive - Recruiting
Prometheus Biosciences Selected Site
Houston, Texas 77030
United StatesActive - Recruiting
UT Physicians Rheumatology ( Site 4007)
Houston, Texas 77030
United StatesSite Not Available
Froedtert and Medical College of Wisconsin ( Site 4012)
Milwaukee, Wisconsin 53226
United StatesSite Not Available
Prometheus Biosciences Selected Site
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
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