A Two-Cohort, Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of Vixarelimab Compared With Placebo in Patients With Idiopathic Pulmonary Fibrosis and in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease

Status: Recruiting
Location: See all (117) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

• 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

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Arizona
Banner University Medicine Lung Institute
RECRUITING
Phoenix
Southern Arizona VA Health Care System NAVREF PPDS
RECRUITING
Tucson
California
University of California, San Francisco-Fresno
RECRUITING
Fresno
UCLA Rheumatology
RECRUITING
Los Angeles
University of Southern California Keck School of Medicine
RECRUITING
Los Angeles
University of California, San Francisco Medical Center
RECRUITING
San Francisco
The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente
ACTIVE_NOT_RECRUITING
Torrance
Florida
Renstar Medical Research
RECRUITING
Ocala
Central Florida Pulmonary Group, PA
WITHDRAWN
Orlando
Coastal Pulmonary and Critical Care PLC
RECRUITING
St. Petersburg
Weston Hospital
RECRUITING
Weston
Georgia
Emory Clinic
RECRUITING
Atlanta
Piedmont Pulmonary and Sleep Medicine Buckhead
RECRUITING
Atlanta
Illinois
GenHarp Clinical Solutions
RECRUITING
Evergreen Park
Northwestern Medicine - Northwestern Medicine Glen
RECRUITING
Glenview
Indiana
IU Health Ball Memorial Physicians Pulmonary and Critical Care Medicine
RECRUITING
Muncie
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Michigan
University of Michigan Hospital
RECRUITING
Ann Arbor
Missouri
Hannibal Regional Healthcare System HRMG Hannibal
RECRUITING
Hannibal
North Carolina
Pulmonix LLC
RECRUITING
Greensboro
Southeastern Research Center
RECRUITING
Winston-salem
Oklahoma
The University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Texas
Baylor Scott and White Health - Advanced Lung Disease Specialists - Dallas
RECRUITING
Dallas
IntraCare Health Center ? Prestige
RECRUITING
Dallas
El Paso Pulmonary Association Elligo PPDS
RECRUITING
El Paso
Baylor College of Medicine
RECRUITING
Houston
McGovern Medical School
RECRUITING
Houston
Utah
University of Utah - PPDS
RECRUITING
Salt Lake City
Other Locations
Argentina
Centro Médico Dra de Salvo
RECRUITING
Buenos Aires
Consultorios Médicos Dr. Doreski
RECRUITING
Ciudad Autonoma Buenos Aires
Instituto Ave Pulmo
RECRUITING
Mar Del Plata
Fundacion Scherbovsky
RECRUITING
Mendoza
INSARES
RECRUITING
Mendoza, Mendoza City
Instituto Medico Rio Cuarto
RECRUITING
Río Cuarto
Instituto Medico de la Fundacion Estudios Clinicos
RECRUITING
Rosario
Centro de Investigaciones Medicas Tucuman
RECRUITING
San Miguel De Tucumán
Centro de Investigaciones Reumatologicas
RECRUITING
San Miguel De Tucumán
Instituto De Patologias Respiratorias
RECRUITING
San Miguel De Tucumán
Instituto Del Buen Aire
RECRUITING
Santa Fe
Australia
Royal Prince Alfred Hospital
RECRUITING
Camperdown
Monash Health Monash Medical Centre
RECRUITING
Clayton
St Vincent's Hospital Sydney
RECRUITING
Darlinghurst
Belgium
AZORG Campus Aalst-Moorselbaan
RECRUITING
Aalst
CHU de Liège
RECRUITING
Liège
AZ Delta
RECRUITING
Roeselare
Brazil
Hospital Dia do Pulmao
RECRUITING
Blumenau
Hospital Brasilia
ACTIVE_NOT_RECRUITING
Brasília
L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
RECRUITING
Brasília
Hospital de Clinicas de Porto Alegre HCPA PPDS
RECRUITING
Pôrto Alegre
Canada
Dynamic Drug Advancement Ltd.
RECRUITING
Ajax
Kelowna Allergy and Respiratory Health Clinic
RECRUITING
Kelowna
Dr Anil Dhar Professional Medicine Corporation
RECRUITING
Windsor
Chile
CEC SpA
RECRUITING
Ñuñoa
Enroll SpA - PPDS
RECRUITING
Providencia
Centro de Investigacion del Maule
RECRUITING
Talca
France
Hopital Avicenne
RECRUITING
Bobigny
Hopital Louis Pradel
RECRUITING
Bron
Hopital Nord AP-HM
RECRUITING
Marseille
Hôpital Arnaud de Villeneuve
RECRUITING
Montpellier
Hopital Pasteur 2
RECRUITING
Nice
Groupe Hospitalier Bichat Claude Bernard
RECRUITING
Paris
CHU de Reims
RECRUITING
Reims
Germany
Evangelische Lungenklinik Berlin
RECRUITING
Berlin
Universitaetsklinikum Duesseldorf
RECRUITING
Düsseldorf
Ruhrlandklinik
RECRUITING
Essen
Greece
University General Hospital of Heraklion
RECRUITING
Heraklion
University General Hospital of Larissa
RECRUITING
Larissa
Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
RECRUITING
Székesfehérvár
Israel
Barzilai Medical Center
RECRUITING
Ashkelon
Shamir Medical Center Assaf Harofeh
RECRUITING
Beer Jacob
Lady Davis Carmel Medical Center
RECRUITING
Haifa
Rambam Medical Center
RECRUITING
Haifa
Hadassah Medical Center
RECRUITING
Jerusalem
Rabin Medical Center
RECRUITING
Petah Tikva
The Chaim Sheba Medical Center
RECRUITING
Ramat Gan
Kaplan Medical Center
RECRUITING
Rehovot
Tel Aviv Sourasky Medical Center PPDS
RECRUITING
Tel Aviv
Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
RECRUITING
Ancona
Azienda Ospedaliera Universitaria Policlinico - Vittorio Emanuele (Presidio Gaspare Rodolico)
RECRUITING
Catania
Azienda Ospedaliera Universitaria Careggi
RECRUITING
Florence
Presidio Ospedaliero GB Morgagni L Pierantoni
RECRUITING
Forlì
Ospedale S. Giuseppe Multimedica
RECRUITING
Milan
Arcispedale Santa Maria Nuova
RECRUITING
Reggio Emilia
Fondazione Policlinico Universitario A Gemelli
RECRUITING
Rome
Azienda Ospedaliera Universitaria Senese
RECRUITING
Siena
Azienda Ospedaliera Città della Salute e della Scienza di Torino
RECRUITING
Turin
Mexico
CICUM San Miguel
RECRUITING
Americana
Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable - PPDS
RECRUITING
Guadalajara
Hospital Universitario Dr. Jose Eleuterio Gonzalez
RECRUITING
Monterrey
New Zealand
Christchurch Hospital
COMPLETED
Christchurch
Dunedin Hospital
RECRUITING
Dunedin
Waikato Hospital
RECRUITING
Hamilton
Poland
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
RECRUITING
Lodz
EMED Centrum Uslug Medycznych Ewa Smialek
RECRUITING
Rzeszów
PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna
RECRUITING
Sosnowiec
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
RECRUITING
Warsaw
Republic of Korea
Gachon University Gil Medical Center
RECRUITING
Incheon
Asan Medical Center - PPDS
RECRUITING
Seoul
Hanyang University Medical Center
RECRUITING
Seoul
Samsung Medical Center - PPDS
RECRUITING
Seoul
The Catholic University of Korea Eunpyeong St. Mary's Hospital
RECRUITING
Seoul
South Africa
Dr JM Engelbrecht Trial site
RECRUITING
Cape Town
University of Cape Town Lung Institute UCTLI
RECRUITING
Cape Town
St Augustines Hospital
RECRUITING
Durban
Spain
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital Universitario de Bellvitge
RECRUITING
L'hospitalet De Llobregat
Hospital Clinico San Carlos
RECRUITING
Madrid
Hospital General Universitario Gregorio Maranon
RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria
RECRUITING
Málaga
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Hospital Universitario Son Espases
RECRUITING
Palma De Mallorca
Hospital Universitario Marques de Valdecilla
RECRUITING
Santander
CHUS H Clinico U de Santiago
RECRUITING
Santiago De Compostela
Taiwan
Far East Memorial Hospital
RECRUITING
New Taipei City
Taichung Veterans General Hospital
RECRUITING
Taichung
Taipei Veterans General Hospital
RECRUITING
Taipei
Contact Information
Primary
Reference Study ID Number: GB44496 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Time Frame
Start Date: 2023-05-26
Estimated Completion Date: 2027-08-10
Participants
Target number of participants: 320
Treatments
Experimental: 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.
Placebo_comparator: 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.
Experimental: DBT: Cohort 2: Vixarelimab
Participants with SSC-ILD will receive vixarelimab, SC, Q2W for 52 weeks in the DBT period.
Placebo_comparator: DBT: Cohort 2: Placebo
Participants with SSC-ILD will receive vixarelimab matching placebo, SC, Q2W for 52 weeks in the DBT period.
Experimental: 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.
Experimental: 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.
Sponsors
Leads: Genentech, Inc.

This content was sourced from clinicaltrials.gov