A Study Evaluating the Efficacy and Safety of Vixarelimab in Participants With Idiopathic Pulmonary Fibrosis and in Participants With Systemic Sclerosis-Associated Interstitial Lung Disease
NCT ID: NCT05785624
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
286 participants
INTERVENTIONAL
2023-05-26
2026-01-09
Brief Summary
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Cohort 1 has completed enrollment and has been closed for further enrollment. Cohort 2 is enrolling participants.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DBT: Cohort 1: Vixarelimab
Participants with IPF will receive vixarelimab, subcutaneously (SC), once every two weeks (Q2W) for 52 weeks in the DBT period. This cohort has completed enrollment and has been closed.
Vixarelimab
Vixarelimab will be administered as per the schedule specified in the respective arms.
DBT: Cohort 1: Placebo
Participants with IPF will receive vixarelimab matching placebo, SC, Q2W for 52 weeks in the DBT period. This cohort has completed enrollment and has been closed.
Placebo
Placebo will be administered as per the schedule specified in the respective arms.
DBT: Cohort 2: Vixarelimab
Participants with SSC-ILD will receive vixarelimab, SC, Q2W for 52 weeks in the DBT period.
Vixarelimab
Vixarelimab will be administered as per the schedule specified in the respective arms.
DBT: Cohort 2: Placebo
Participants with SSC-ILD will receive vixarelimab matching placebo, SC, Q2W for 52 weeks in the DBT period.
Placebo
Placebo will be administered as per the schedule specified in the respective arms.
OLE Period: Cohort 1: Vixarelimab
Participants with IPF who complete 52 weeks of treatment in the DBT period can choose to enroll in the OLE period to receive vixarelimab, SC, Q2W for 52 weeks.
Vixarelimab
Vixarelimab will be administered as per the schedule specified in the respective arms.
OLE Period: Cohort 2: Vixarelimab
Participants with SSC-ILD who complete 52 weeks of treatment in the DBT period can choose to enroll in the OLE period to receive vixarelimab, SC, Q2W for 52 weeks.
Vixarelimab
Vixarelimab will be administered as per the schedule specified in the respective arms.
Interventions
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Vixarelimab
Vixarelimab will be administered as per the schedule specified in the respective arms.
Placebo
Placebo will be administered as per the schedule specified in the respective arms.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* 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
* 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
* 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
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner University Medicine Lung Institute
Phoenix, Arizona, United States
Southern Arizona VA Health Care System NAVREF PPDS
Tucson, Arizona, United States
University of California, San Francisco-Fresno
Fresno, California, United States
University of Southern California Keck School of Medicine
Los Angeles, California, United States
UCLA Rheumatology
Los Angeles, California, United States
University of California, San Francisco Medical Center
San Francisco, California, United States
The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente
Torrance, California, United States
Renstar Medical Research
Ocala, Florida, United States
Coastal Pulmonary and Critical Care PLC
St. Petersburg, Florida, United States
Weston Hospital
Weston, Florida, United States
Piedmont Pulmonary and Sleep Medicine Buckhead
Atlanta, Georgia, United States
Emory Clinic
Atlanta, Georgia, United States
GenHarp Clinical Solutions
Evergreen Park, Illinois, United States
Northwestern Medicine - Northwestern Medicine Glen
Glenview, Illinois, United States
IU Health Ball Memorial Physicians Pulmonary and Critical Care Medicine
Muncie, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
Hannibal Regional Healthcare System HRMG Hannibal
Hannibal, Missouri, United States
Pulmonix LLC
Greensboro, North Carolina, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Baylor Scott and White Health - Advanced Lung Disease Specialists - Dallas
Dallas, Texas, United States
IntraCare Health Center ? Prestige
Dallas, Texas, United States
El Paso Pulmonary Association Elligo PPDS
El Paso, Texas, United States
McGovern Medical School
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Utah - PPDS
Salt Lake City, Utah, United States
Centro Médico Dra de Salvo
Buenos Aires, , Argentina
Consultorios Médicos Dr. Doreski
Ciudad Autonoma Buenos Aires, , Argentina
Instituto Ave Pulmo
Mar del Plata, , Argentina
Fundacion Scherbovsky
Mendoza, , Argentina
INSARES
Mendoza, Mendoza City, , Argentina
Instituto Medico Rio Cuarto
Río Cuarto, , Argentina
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, , Argentina
Instituto De Patologias Respiratorias
San Miguel de Tucumán, , Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, , Argentina
Centro de Investigaciones Reumatologicas
San Miguel de Tucumán, , Argentina
Instituto Del Buen Aire
Santa Fe, , Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Monash Health Monash Medical Centre
Clayton, Victoria, Australia
AZORG Campus Aalst-Moorselbaan
Aalst, , Belgium
CHU de Liège
Liège, , Belgium
L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
Brasília, Federal District, Brazil
Hospital Brasilia
Brasília, Federal District, Brazil
Hospital de Clinicas de Porto Alegre HCPA PPDS
Pôrto Alegre, Pará, Brazil
Hospital Dia do Pulmao
Blumenau, Santa Catarina, Brazil
Kelowna Allergy and Respiratory Health Clinic
Kelowna, British Columbia, Canada
Dynamic Drug Advancement Ltd.
Ajax, Ontario, Canada
Dr Anil Dhar Professional Medicine Corporation
Windsor, Ontario, Canada
CEC SpA
Ñuñoa, , Chile
Enroll SpA - PPDS
Providencia, , Chile
Centro de Investigacion del Maule
Talca, , Chile
Hopital Avicenne
Bobigny, , France
Hopital Louis Pradel
Bron, , France
Hopital Nord AP-HM
Marseille, , France
Hôpital Arnaud de Villeneuve
Montpellier, , France
Hopital Pasteur 2
Nice, , France
Groupe Hospitalier Bichat Claude Bernard
Paris, , France
CHU de Reims
Reims, , France
Evangelische Lungenklinik Berlin
Berlin, , Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, , Germany
Ruhrlandklinik
Essen, , Germany
University General Hospital of Heraklion
Heraklion, , Greece
University General Hospital of Larissa
Larissa, , Greece
Barzilai Medical Center
Ashkelon, , Israel
Shamir Medical Center Assaf Harofeh
Beer Jacob, , Israel
Rambam Medical Center
Haifa, , Israel
Lady Davis Carmel Medical Center
Haifa, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
The Chaim Sheba Medical Center
Ramat Gan, , Israel
Kaplan Medical Center
Rehovot, , Israel
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv, , Israel
Azienda Ospedaliera Universitaria Senese
Siena, Abruzzo, Italy
Presidio Ospedaliero GB Morgagni L Pierantoni
Forlì, Emilia-Romagna, Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, Emilia-Romagna, Italy
Fondazione Policlinico Universitario A Gemelli
Rome, Lazio, Italy
Ospedale S. Giuseppe Multimedica
Milan, Lombardy, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Turin, Piedmont, Italy
Azienda Ospedaliera Universitaria "Policlinico - Vittorio Emanuele" (Presidio Gaspare Rodolico)
Catania, Sicily, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
Ancona, The Marches, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, Italy
CICUM San Miguel
Americana, Jalisco, Mexico
Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable - PPDS
Guadalajara, Jalisco, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico
Christchurch Hospital
Christchurch, , New Zealand
Dunedin Hospital
Dunedin, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, , Poland
EMED Centrum Uslug Medycznych Ewa Smialek
Rzeszów, , Poland
PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna
Sosnowiec, , Poland
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Warsaw, , Poland
Dr JM Engelbrecht Trial site
Cape Town, , South Africa
University of Cape Town Lung Institute UCTLI
Cape Town, , South Africa
St Augustines Hospital
Durban, , South Africa
Gachon University Gil Medical Center
Incheon, , South Korea
The Catholic University of Korea Eunpyeong St. Mary's Hospital
Seoul, , South Korea
Hanyang University Medical Center
Seoul, , South Korea
Asan Medical Center - PPDS
Seoul, , South Korea
Samsung Medical Center - PPDS
Seoul, , South Korea
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
CHUS H Clinico U de Santiago
Santiago de Compostela, LA Coruna, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Son Espases
Palma de Mallorca, , Spain
Far East Memorial Hospital
New Taipei City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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2022-502828-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2022-502828-42-00
Identifier Type: CTIS
Identifier Source: secondary_id
GB44496
Identifier Type: -
Identifier Source: org_study_id
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