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
- Conditions
- Idiopathic Pulmonary FibrosisSystemic Sclerosis With Lung Involvement
- Interventions
- Drug: Placebo
- Registration Number
- NCT05785624
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
The main purpose of the study is to evaluate the efficacy of vixarelimab compared with placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Participants who complete 52-weeks of treatment in the Double-blind Treatment (DBT) period can choose to enroll in the optional Open-label Extension (OLE) period to receive treatment with vixarelimab for another 52 weeks.
Cohort 1 has completed enrollment and has been closed for further enrollment. Cohort 2 is enrolling participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 320
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DBT: Cohort 1: Vixarelimab 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. DBT: Cohort 1: Placebo 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. DBT: Cohort 2: Vixarelimab Vixarelimab Participants with SSC-ILD will receive vixarelimab, SC, Q2W for 52 weeks in the DBT period. DBT: Cohort 2: Placebo Placebo Participants with SSC-ILD will receive vixarelimab matching placebo, SC, Q2W for 52 weeks in the DBT period. OLE Period: Cohort 1: Vixarelimab 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. OLE Period: Cohort 2: Vixarelimab 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.
- Primary Outcome Measures
Name Time Method Cohorts 1 and 2: Absolute Change From Baseline in Forced Vital Capacity (FVC) Baseline up to Week 52 FVC is a pulmonary function test parameter that indicates the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It's measured by spirometry, which is a common breathing test to check lung function.
- Secondary Outcome Measures
Name Time Method Cohorts 1 and 2: Absolute Change From Baseline in Percentage of Predicted FVC Baseline up to Week 52 FVC is a pulmonary function test parameter that indicates the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It's measured by spirometry, which is a common breathing test to check lung function.
Cohorts 1 and 2: Change From Baseline in Health-Related Quality of Life (HRQoL) Measured Using King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Baseline up to Week 52 K-BILD is a questionnaire that assesses HRQoL in ILDs. It consists of 15 items grouped into psychological, breathlessness and activity, and chest symptom domains, each scored individually on a 7-point scale, with domain-level and total scores transformed 0-100, with higher scores indicating better quality of life. It uses a 2-week recall period.
Cohorts 1 and 2: Change From Baseline in Dyspnea Measured Using L-PF Symptoms Dyspnea Domain Score Baseline up to Week 52 The L-PF symptoms module is a 23-item tool with domains capturing shortness of breath, cough, and energy symptoms using a 0-4 NRS response format and a 24-hour recall period. L-PF Symptoms Dyspnea Domain score (dyspnea score) ranges from 0 to 100, with higher score indicating greater impairment.
Cohorts 1 and 2: Time to First Acute Exacerbation of ILD, or Suspected Acute Exacerbation of ILD From the start of study treatment until end of DBT (up to Week 52) Cohorts 1, 2 and OLE Period: Number of Participants With Adverse Events (AEs) Up to Week 52 Cohorts 1 and 2: Absolute Change From Baseline in 6-Minute Walk Test (6MWT) Distance Baseline up to Week 52 The 6MWT test is performed indoors on a flat, straight corridor with a hard surface at least 30 meters (m) in length. 6MWT measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes. 6MWT measure will be calculated as the simple difference between baseline distance walked over 6 minutes and week 52 distance walked over 6 minutes as measured in meters.
Cohorts 1 and 2: Change From Baseline in Diffusion Capacity of the Lung for Carbon Monoxide Adjusted for Hemoglobin (DLco [Hb]) Baseline up to Week 52 DLCO measures the ability of the lungs to transfer gas from inhaled air to the red blood cells in the blood. DLCO is adjusted for hemoglobin as small changes in hemoglobin concentration can affect the carbon monoxide transfer.
Cohorts 1 and 2: Time to Disease Progression From the start of study treatment until disease progression or death, whichever occurs first (up to Week 52 of DBT) Time to disease progression is defined as time to first occurrence of ≥10% absolute decline in percentage of predicted FVC, ≥15% relative decline in 6MWT distance, lung transplantation, or death. FVC=pulmonary function test parameter that indicates the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It's measured by spirometry, which is a common breathing test to check lung function. 6MWT test is performed indoors on a flat, straight corridor with a hard surface at least 30 m in length. 6MWT measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes. 6MWT measure will be calculated as the simple difference between baseline distance walked over 6 minutes and week 52 distance walked over 6 minutes as measured in meters.
Cohorts 1 and 2: Change From Baseline in Quantitative Lung Fibrosis on High-Resolution Computed Tomography (HRCT) Scan of the Thorax Baseline up to Week 52 High-resolution computer tomography (HRCT) is a type of computed tomography (CT) with specific techniques to enhance image resolution. It is used in the diagnosis of various health problems, most commonly for lung disease. These images show cross sections (slices) through the lungs.
Cohort 2: Change From Baseline in Skin Sclerosis Assessed Using Modified Rodnan Skin Score (mRSS) Baseline up to Week 52 mRSS is a measure of skin thickness. Skin thickness will be assessed by the investigator by palpation across 17 different body sites and scored on a scale of 0 (normal) to 3 (severe skin thickening). The total score is the sum of the individual skin scores from all of these sites and ranges from 0 (normal) to 51 (severe thickening in all 17 areas) units. Higher scores indicate disease worsening.
Cohorts 1 and 2: Change From Baseline in Cough Measured Using Living with Pulmonary Fibrosis (L-PF) Symptoms Cough Domain Score Baseline up to Week 52 The L-PF symptoms module is a 23-item tool with domains capturing shortness of breath, cough, and energy symptoms using a 0-4 numeric response scale (NRS) response format and a 24-hour recall period. The cough scores ranges from 0 to 100 with higher scores indicating greater symptom burden/impairment.
Cohorts 1 and 2: Percentage of Participants with Deaths Up to Week 52 Cohort 2: Change From Baseline in Pruritus Measured Using the Five-Dimension Itch Scale (5-D Itch) Total Score Baseline up to Week 52 The 5-D-Itch questionnaire that measures itch and its impact. It consists of 8 items organized into 5 domains (duration, degree, direction, disability, and distribution). Each domain is scored 1 to 5 with a total score ranging from 5 to 25 with higher scores indicating greater itch severity.
Cohorts 1 and 2: Serum Concentration of Vixarelimab Baseline up to Week 52 Cohorts 1 and 2: Number of Participants With Anti-Drug Antibodies (ADAs) to Vixarelimab Baseline up to Week 52
Trial Locations
- Locations (113)
Instituto De Patologias Respiratorias
🇦🇷San Miguel de Tucuman, Argentina
Centro de Investigaciones Medicas Tucuman
🇦🇷San Miguel de Tucuman, Argentina
Instituto Medico de la Fundacion Estudios Clinicos
🇦🇷Rosario, Argentina
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
Central Florida Pulmonary Group, PA
🇺🇸Orlando, Florida, United States
Coastal Pulmonary and Critical Care PLC
🇺🇸Saint Petersburg, Florida, United States
Weston Hospital
🇺🇸Weston, Florida, United States
Piedmont Pulmonary and Sleep Medicine Buckhead
🇺🇸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
INSARES
🇦🇷Mendoza, Mendoza City, Argentina
Fundacion Scherbovsky
🇦🇷Mendoza, Argentina
Instituto Medico Rio Cuarto
🇦🇷Rio Cuarto, Argentina
Hôpital Arnaud de Villeneuve
🇫🇷Montpellier, France
Centro de Investigaciones Reumatologicas
🇦🇷San Miguel de Tucuman, 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
AZ Delta
🇧🇪Roeselare, Belgium
L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
🇧🇷Brasilia, Distrito Federal, Brazil
Hospital Brasilia
🇧🇷Brasilia, Distrito Federal, Brazil
Hospital de Clinicas de Porto Alegre HCPA PPDS
🇧🇷Porto 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
🇨🇱Nunoa, 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
Hopital Pasteur 2
🇫🇷Nice Cedex 1, France
Groupe Hospitalier Bichat Claude Bernard
🇫🇷Paris, France
CHU de Reims
🇫🇷Reims, France
Evangelische Lungenklinik Berlin
🇩🇪Berlin, Germany
Ruhrlandklinik
🇩🇪Essen, Germany
University General Hospital of Heraklion
🇬🇷Herakleion, Greece
University General Hospital of Larissa
🇬🇷Larissa, Greece
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
🇭🇺Székesfehérvár, Hungary
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-Yafo, Israel
Azienda Ospedaliera Universitaria Senese
🇮🇹Siena, Abruzzo, Italy
Presidio Ospedaliero GB Morgagni L Pierantoni
🇮🇹Forli', Emilia-Romagna, Italy
Fondazione Policlinico Universitario A Gemelli
🇮🇹Roma, Lazio, Italy
Ospedale S. Giuseppe Multimedica
🇮🇹Milano, Lombardia, Italy
Waikato Hospital
🇳🇿Hamilton, New Zealand
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
🇮🇹Ancona, Marche, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
🇮🇹Torino, Piemonte, Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
🇮🇹Catania, Sicilia, Italy
Azienda Ospedaliera Universitaria Careggi
🇮🇹Florence, Toscana, Italy
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
The Catholic University of Korea Eunpyeong St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Hanyang University Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center - PPDS
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center - PPDS
🇰🇷Seoul, Korea, Republic of
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 LEON, Mexico
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Dunedin Hospital
🇳🇿Dunedin, New Zealand
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
🇵🇱Lodz, Poland
EMED Centrum Uslug Medycznych Ewa Smialek
🇵🇱Rzeszow, Poland
PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna
🇵🇱Sosnowiec, Poland
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
🇵🇱Warszawa, 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
Hospital Universitario de Bellvitge
🇪🇸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 Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Malaga, Spain
Hospital Universitario Son Espases
🇪🇸Palma de Mallorca, Spain
Far East Memorial Hospital
🇨🇳New Taipei, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei City, Taiwan