Phase
Condition
Pulmonary Fibrosis
Cystic Fibrosis
Idiopathic Pulmonary Fibrosis
Treatment
Placebo
Vixarelimab
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria for all Participants:
FVC ≥45% predicted during screening as determined by the over-reader
Forced expiratory volume in 1 second (FEV1)/FVC ratio >0.70 during screening as determined by the over-reader
DLco ≥30% and ≤90% of predicted during screening (Hgb corrected) as determined by the over-reader
Minimum 6-MWT distance of 150 m with maximum use of 6 liters per minute (L/min) at sea-level and up to 8 L/min at altitude (> 5000 feet [1524 m] above sea level) of supplemental oxygen while maintaining oxygen saturation of >83% during the 6MWT during screening
Participant and investigator consideration of all medicinal treatment options and/or possibly lung transplantation prior to consideration of participation in the study
Inclusion Criteria for Cohort 1:
Age 40-85 years
Documented diagnosis of IPF or IPF (likely)
HRCT pattern consistent with the diagnosis of IPF, confirmed by central review of chest HRCT and central review of any available lung biopsy
For participants receiving pirfenidone or nintedanib treatment for IPF: treatment for ≥3 months with a stable dose for ≥4 weeks prior to screening and during screening, with plans to continue treatment during the study period
Inclusion Criteria for Cohort 2:
Age 18-85 years
Diagnosis of SSc as defined using the American College of Rheumatology/European Alliance of Associations for Rheumatology (EULAR) criteria
HRCT demonstrating ≥10% extent of fibrosis, confirmed by central review of Chest HRCT
Evidence of progression of pulmonary fibrosis
For participants receiving tocilizumab treatment for SSc-ILD: treatment for ≥3 months with a stable dose for ≥4 weeks prior to screening and during screening, with no contraindications according to local prescribing information, and no intention to change or modify their treatment regimen for the duration of the study
For participants receiving nintedanib treatment for SSc-ILD: treatment for ≥ 3 months with a stable dose for ≥ 4 weeks prior to screening and during screening, with no contraindications according to local prescribing information, and no intention to change or modify their treatment regimen for the duration of the study
Availability of skin for biopsy preferably on proximal forearms having Modified Rodnan Skin Score (mRSS) ≥2 at the biopsy location
Inclusion Criteria for OLE Period:
Completion of 52 weeks of treatment in the double-blinded treatment period
Investigator determination of a favorable benefit-risk for the individual participant, i.e., the expectation of reasonable likelihood for therapeutic benefit and tolerability of the study drug after evaluation of the preceding 52 weeks of double-blinded treatment
Exclusion Criteria for all Participants:
Percentage of predicted FVC value showing improvement in the 6-month period prior to screening and including screening value
Known post-bronchodilator response in FEV1 and/or FVC (defined as an increase in percent predicted values by ≥ 10)
Resting oxygen saturation of <89% using up to 4 L/min of supplemental oxygen at sea level and up to 6 L/min at altitude (5000 feet [1524 m] above sea level) during screening
History of lung transplant
Previous treatment with vixarelimab
Acute respiratory or systemic bacterial, viral, or fungal infection either during screening or prior to screening not successfully resolved by 4 weeks prior to screening visit
Presence of pulmonary hypertension requiring treatment
History of malignancy within the 5 years prior to screening
Positive hepatitis C virus (HCV) antibody test result accompanied by a positive HCV ribonucleic acid (RNA) test at screening
Known immunodeficiency
Known evidence of active or untreated latent tuberculosis
Exclusion Criteria for Cohort 1:
Evidence of other known causes of ILD
Emphysema present on ≥50% of the HRCT, or the extent of emphysema is greater than the extent of fibrosis, according to central review of the HRCT
Exclusion Criteria for Cohort 2:
Evidence of other known causes of ILD
Rheumatic autoimmune disease other than SSc
Receiving pirfenidone treatment within 4 weeks prior to screening
Receipt of nintedanib in combination with tocilizumab
Exclusion Criteria for OLE Period:
Significant non-compliance in the double-blinded treatment period, per investigator's judgment
Any new clinically significant pulmonary disease other than IPF or SSc-ILD since enrolling in the double-blinded treatment period
Study Design
Connect with a study center
Centro Médico Dra de Salvo
Buenos Aires, C1426ABP
ArgentinaActive - Recruiting
Consultorios Médicos Dr. Doreski
Ciudad Autonoma Buenos Aires, C1426ABP
ArgentinaActive - Recruiting
Instituto Medico Rio Cuarto
Cordoba, X5800AEU
ArgentinaSite Not Available
Instituto Ave Pulmo
Mar Del Plata, B7602DCK
ArgentinaActive - Recruiting
Fundacion Scherbovsky
Mendoza, 5500
ArgentinaActive - Recruiting
INSARES
Mendoza, Mendoza City, M5500CCG
ArgentinaActive - Recruiting
Instituto Medico Rio Cuarto
Rio Cuarto, 5800
ArgentinaActive - Recruiting
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, S2013DTC
ArgentinaActive - Recruiting
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucuman, T4000AXL
ArgentinaActive - Recruiting
Centro de Investigaciones Reumatologicas
San Miguel de Tucuman, T4000AXL
ArgentinaActive - Recruiting
Instituto De Patologias Respiratorias
San Miguel de Tucuman, 4000
ArgentinaActive - Recruiting
Instituto Del Buen Aire
Santa Fe, 3000
ArgentinaActive - Recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales 2050
AustraliaActive - Recruiting
St Vincent's Hospital Sydney
Darlinghurst, New South Wales 2010
AustraliaActive - Recruiting
Monash Health Monash Medical Centre
Clayton, Victoria 3168
AustraliaActive - Recruiting
AZORG Campus Aalst-Moorselbaan
Aalst, 9300
BelgiumActive - Recruiting
Onze Lieve Vrouwziekenhuis Aalst
Aalst, 9300
BelgiumActive - Recruiting
CHU de Liège
Liège, 4000
BelgiumActive - Recruiting
AZ Delta
Roeselare, 8800
BelgiumActive - Recruiting
Hospital Brasilia
Brasilia, Distrito Federal 71635580
BrazilSite Not Available
L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
Brasilia, Distrito Federal 70200-730
BrazilActive - Recruiting
Hospital de Clinicas de Porto Alegre HCPA PPDS
Porto Alegre, Pará 90035-903
BrazilActive - Recruiting
Hospital Dia do Pulmao
Blumenau, Santa Catarina 89030-101
BrazilActive - Recruiting
Kelowna Allergy and Respiratory Health Clinic
Kelowna, British Columbia V1W 1V3
CanadaActive - Recruiting
Dynamic Drug Advancement Ltd.
Ajax, Ontario L1S 2J5
CanadaActive - Recruiting
Dr Anil Dhar Professional Medicine Corporation
Windsor, Ontario N8X 5A6
CanadaActive - Recruiting
CEC SpA
Nunoa, 7750495
ChileActive - Recruiting
Enroll SpA - PPDS
Providencia, 7500587
ChileActive - Recruiting
Centro de Investigacion del Maule
Talca, 3481349
ChileActive - Recruiting
Hopital Avicenne
Bobigny, 93000
FranceActive - Recruiting
Hopital Louis Pradel
Bron, 69677
FranceActive - Recruiting
Hopital Nord AP-HM
Marseille, 13015
FranceActive - Recruiting
Hôpital Arnaud de Villeneuve
Montpellier, 34295
FranceActive - Recruiting
Hopital Pasteur 2
Nice Cedex 1, 06001
FranceActive - Recruiting
Groupe Hospitalier Bichat Claude Bernard
Paris, 75018
FranceActive - Recruiting
CHU de Reims
Reims, 51100
FranceActive - Recruiting
Evangelische Lungenklinik Berlin
Berlin, 13125
GermanyActive - Recruiting
Ruhrlandklinik
Essen, 45239
GermanyActive - Recruiting
University General Hospital of Heraklion
Herakleion, 711 10
GreeceActive - Recruiting
University General Hospital of Heraklion
Heraklio, 711 10
GreeceSite Not Available
University General Hospital of Larissa
Larissa, 412 21
GreeceActive - Recruiting
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000
HungaryActive - Recruiting
Barzilai Medical Center
Ashkelon, 7830604
IsraelActive - Recruiting
Shamir Medical Center Assaf Harofeh
Be'er Ya'akov, 7033001
IsraelSite Not Available
Shamir Medical Center Assaf Harofeh
Beer Jacob, 0073100
IsraelActive - Recruiting
Lady Davis Carmel Medical Center
Haifa, 34362
IsraelActive - Recruiting
Rambam Medical Center
Haifa, 3109601
IsraelActive - Recruiting
Hadassah Medical Center
Jerusalem, 9112001
IsraelActive - Recruiting
Rabin Medical Center
Petah Tikva, 52621
IsraelActive - Recruiting
Sheba Medical Center - PPDS
Ramat Gan, 5266202
IsraelSite Not Available
The Chaim Sheba Medical Center
Ramat Gan, 5262100
IsraelActive - Recruiting
Sheba Medical Center - PPDS
Ramat-Gan, 5262000
IsraelSite Not Available
Kaplan Medical Center
Rehovot, 7610001
IsraelActive - Recruiting
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv-Yafo, 6423906
IsraelActive - Recruiting
Azienda Ospedaliera Universitaria Senese
Siena, Abruzzo 53100
ItalyActive - Recruiting
Presidio Ospedaliero GB Morgagni L Pierantoni
Forli', Emilia-Romagna 47121
ItalyActive - Recruiting
Fondazione Policlinico Universitario A Gemelli
Roma, Lazio 00168
ItalyActive - Recruiting
Ospedale S. Giuseppe Multimedica
Milano, Lombardia 20123
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
Ancona, Marche 60020
ItalyActive - Recruiting
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, Piemonte 10126
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania, Sicilia 95123
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Careggi
Florence, Toscana 50134
ItalyActive - Recruiting
Gachon University Gil Medical Center
Incheon, 21565
Korea, Republic ofActive - Recruiting
Asan Medical Center - PPDS
Seoul, 05505
Korea, Republic ofActive - Recruiting
Hanyang University Medical Center
Seoul, 04763
Korea, Republic ofActive - Recruiting
Samsung Medical Center - PPDS
Seoul, 06351
Korea, Republic ofActive - Recruiting
The Catholic University of Korea Eunpyeong St. Mary's Hospital
Seoul, 03312
Korea, Republic ofActive - Recruiting
CICUM San Miguel
Americana, Jalisco 44160
MexicoActive - Recruiting
Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable - PPDS
Guadalajara, Jalisco CP 44160
MexicoActive - Recruiting
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo LEON
MexicoActive - Recruiting
Christchurch Hospital
Christchurch, 8011
New ZealandCompleted
Dunedin Hospital
Dunedin,
New ZealandActive - Recruiting
Waikato Hospital
Hamilton, 3248
New ZealandActive - Recruiting
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, 90-153
PolandActive - Recruiting
EMED Centrum Uslug Medycznych Ewa Smialek
Rzeszow, 35-205
PolandActive - Recruiting
EMED Centrum Uslug Medycznych Ewa Smialek
Rzeszów, 35-205
PolandSite Not Available
PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna
Sosnowiec, 41-208
PolandActive - Recruiting
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Warszawa, 04-141
PolandActive - Recruiting
Dr JM Engelbrecht Trial site
Cape Town, 7130
South AfricaActive - Recruiting
University of Cape Town Lung Institute UCTLI
Cape Town, 7700
South AfricaActive - Recruiting
Panorama Medical Centre
City Of Cape Town, 7500
South AfricaSite Not Available
St Augustines Hospital
Durban, 4001
South AfricaActive - Recruiting
Hospital Universitario de Bellvitge
Hospitalet de Llobregat, Barcelona 08907
SpainActive - Recruiting
Hospital Universitario Marques de Valdecilla
Santander, Cantabria 39008
SpainActive - Recruiting
CHUS H Clinico U de Santiago
Santiago de Compostela, LA Coruna 15706
SpainActive - Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hospital Clinico San Carlos
Madrid, 28040
SpainActive - Recruiting
Hospital General Universitario Gregorio Maranon
Madrid, 28040
SpainActive - Recruiting
Hospital Universitario Virgen de la Victoria
Malaga, 29010
SpainActive - Recruiting
Hospital Universitario Son Espases
Palma de Mallorca, 07120
SpainActive - Recruiting
Far East Memorial Hospital
New Taipei, 220
TaiwanActive - Recruiting
Taichung Veterans General Hospital
Taichung, 40705
TaiwanActive - Recruiting
Taipei Veterans General Hospital
Taipei City, 11217
TaiwanActive - Recruiting
University of Alabama at Birmingham
Birmingham, Alabama 35233
United StatesActive - Recruiting
Banner University Medicine Lung Institute
Phoenix, Arizona 85006-2506
United StatesActive - Recruiting
Southern Arizona VA Health Care System NAVREF PPDS
Tucson, Arizona 85723-0001
United StatesActive - Recruiting
University of California, San Francisco-Fresno
Fresno, California 93701-2302
United StatesActive - Recruiting
UCLA Rheumatology
Los Angeles, California 90095-8344
United StatesActive - Recruiting
University of Southern California Keck School of Medicine
Los Angeles, California 90033-1036
United StatesActive - Recruiting
University of California, San Francisco Medical Center
San Francisco, California 94143-2204
United StatesActive - Recruiting
The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente
Torrance, California 90502
United StatesSite Not Available
Renstar Medical Research
Ocala, Florida 34470
United StatesActive - Recruiting
Central Florida Pulmonary Group, PA
Orlando, Florida 32803
United StatesActive - Recruiting
Coastal Pulmonary and Critical Care PLC
Saint Petersburg, Florida 33704-2733
United StatesActive - Recruiting
Weston Hospital
Weston, Florida 33331-3609
United StatesActive - Recruiting
Piedmont Pulmonary and Sleep Medicine Buckhead
Atlanta, Georgia 30309-1740
United StatesActive - Recruiting
GenHarp Clinical Solutions
Evergreen Park, Illinois 60805-2758
United StatesActive - Recruiting
Northwestern Medicine - Northwestern Medicine Glen
Glenview, Illinois 60026-8039
United StatesActive - Recruiting
IU Health Ball Memorial Physicians Pulmonary and Critical Care Medicine
Muncie, Indiana 47303-3432
United StatesActive - Recruiting
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesActive - Recruiting
University of Michigan Hospital
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Hannibal Clinic
Hannibal, Missouri 63401
United StatesActive - Recruiting
Hannibal Regional Healthcare System HRMG Hannibal
Hannibal, Missouri 63401-6890
United StatesActive - Recruiting
Pulmonix LLC
Greensboro, North Carolina 27403-4443
United StatesActive - Recruiting
Southeastern Research Center
Winston-Salem, North Carolina 27103-4029
United StatesActive - Recruiting
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104-5417
United StatesActive - Recruiting
Baylor Scott and White Health - Advanced Lung Disease Specialists - Dallas
Dallas, Texas 75246-2073
United StatesActive - Recruiting
IntraCare Health Center ? Prestige
Dallas, Texas 75254
United StatesActive - Recruiting
El Paso Pulmonary Association Elligo PPDS
El Paso, Texas 79902-1124
United StatesActive - Recruiting
Baylor College of Medicine
Houston, Texas 77030
United StatesActive - Recruiting
McGovern Medical School
Houston, Texas 77030-1501
United StatesActive - Recruiting
Research Centers of America
McKinney, Texas 75071-7824
United StatesSite Not Available
University of Utah - PPDS
Salt Lake City, Utah 84108-1287
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.