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

Last updated: March 13, 2025
Sponsor: Genentech, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Pulmonary Fibrosis

Cystic Fibrosis

Idiopathic Pulmonary Fibrosis

Treatment

Placebo

Vixarelimab

Clinical Study ID

NCT05785624
GB44496
2022-502828-42
  • Ages 18-85
  • All Genders

Study 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.

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

Total Participants: 320
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
May 26, 2023
Estimated Completion Date:
August 10, 2027

Connect with a study center

  • Centro Médico Dra de Salvo

    Buenos Aires, C1426ABP
    Argentina

    Active - Recruiting

  • Consultorios Médicos Dr. Doreski

    Ciudad Autonoma Buenos Aires, C1426ABP
    Argentina

    Active - Recruiting

  • Instituto Medico Rio Cuarto

    Cordoba, X5800AEU
    Argentina

    Site Not Available

  • Instituto Ave Pulmo

    Mar Del Plata, B7602DCK
    Argentina

    Active - Recruiting

  • Fundacion Scherbovsky

    Mendoza, 5500
    Argentina

    Active - Recruiting

  • INSARES

    Mendoza, Mendoza City, M5500CCG
    Argentina

    Active - Recruiting

  • Instituto Medico Rio Cuarto

    Rio Cuarto, 5800
    Argentina

    Active - Recruiting

  • Instituto Medico de la Fundacion Estudios Clinicos

    Rosario, S2013DTC
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucuman, T4000AXL
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Reumatologicas

    San Miguel de Tucuman, T4000AXL
    Argentina

    Active - Recruiting

  • Instituto De Patologias Respiratorias

    San Miguel de Tucuman, 4000
    Argentina

    Active - Recruiting

  • Instituto Del Buen Aire

    Santa Fe, 3000
    Argentina

    Active - Recruiting

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

  • Monash Health Monash Medical Centre

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • AZORG Campus Aalst-Moorselbaan

    Aalst, 9300
    Belgium

    Active - Recruiting

  • Onze Lieve Vrouwziekenhuis Aalst

    Aalst, 9300
    Belgium

    Active - Recruiting

  • CHU de Liège

    Liège, 4000
    Belgium

    Active - Recruiting

  • AZ Delta

    Roeselare, 8800
    Belgium

    Active - Recruiting

  • Hospital Brasilia

    Brasilia, Distrito Federal 71635580
    Brazil

    Site Not Available

  • L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME

    Brasilia, Distrito Federal 70200-730
    Brazil

    Active - Recruiting

  • Hospital de Clinicas de Porto Alegre HCPA PPDS

    Porto Alegre, Pará 90035-903
    Brazil

    Active - Recruiting

  • Hospital Dia do Pulmao

    Blumenau, Santa Catarina 89030-101
    Brazil

    Active - Recruiting

  • Kelowna Allergy and Respiratory Health Clinic

    Kelowna, British Columbia V1W 1V3
    Canada

    Active - Recruiting

  • Dynamic Drug Advancement Ltd.

    Ajax, Ontario L1S 2J5
    Canada

    Active - Recruiting

  • Dr Anil Dhar Professional Medicine Corporation

    Windsor, Ontario N8X 5A6
    Canada

    Active - Recruiting

  • CEC SpA

    Nunoa, 7750495
    Chile

    Active - Recruiting

  • Enroll SpA - PPDS

    Providencia, 7500587
    Chile

    Active - Recruiting

  • Centro de Investigacion del Maule

    Talca, 3481349
    Chile

    Active - Recruiting

  • Hopital Avicenne

    Bobigny, 93000
    France

    Active - Recruiting

  • Hopital Louis Pradel

    Bron, 69677
    France

    Active - Recruiting

  • Hopital Nord AP-HM

    Marseille, 13015
    France

    Active - Recruiting

  • Hôpital Arnaud de Villeneuve

    Montpellier, 34295
    France

    Active - Recruiting

  • Hopital Pasteur 2

    Nice Cedex 1, 06001
    France

    Active - Recruiting

  • Groupe Hospitalier Bichat Claude Bernard

    Paris, 75018
    France

    Active - Recruiting

  • CHU de Reims

    Reims, 51100
    France

    Active - Recruiting

  • Evangelische Lungenklinik Berlin

    Berlin, 13125
    Germany

    Active - Recruiting

  • Ruhrlandklinik

    Essen, 45239
    Germany

    Active - Recruiting

  • University General Hospital of Heraklion

    Herakleion, 711 10
    Greece

    Active - Recruiting

  • University General Hospital of Heraklion

    Heraklio, 711 10
    Greece

    Site Not Available

  • University General Hospital of Larissa

    Larissa, 412 21
    Greece

    Active - Recruiting

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000
    Hungary

    Active - Recruiting

  • Barzilai Medical Center

    Ashkelon, 7830604
    Israel

    Active - Recruiting

  • Shamir Medical Center Assaf Harofeh

    Be'er Ya'akov, 7033001
    Israel

    Site Not Available

  • Shamir Medical Center Assaf Harofeh

    Beer Jacob, 0073100
    Israel

    Active - Recruiting

  • Lady Davis Carmel Medical Center

    Haifa, 34362
    Israel

    Active - Recruiting

  • Rambam Medical Center

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Hadassah Medical Center

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Rabin Medical Center

    Petah Tikva, 52621
    Israel

    Active - Recruiting

  • Sheba Medical Center - PPDS

    Ramat Gan, 5266202
    Israel

    Site Not Available

  • The Chaim Sheba Medical Center

    Ramat Gan, 5262100
    Israel

    Active - Recruiting

  • Sheba Medical Center - PPDS

    Ramat-Gan, 5262000
    Israel

    Site Not Available

  • Kaplan Medical Center

    Rehovot, 7610001
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center PPDS

    Tel Aviv-Yafo, 6423906
    Israel

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Senese

    Siena, Abruzzo 53100
    Italy

    Active - Recruiting

  • Presidio Ospedaliero GB Morgagni L Pierantoni

    Forli', Emilia-Romagna 47121
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario A Gemelli

    Roma, Lazio 00168
    Italy

    Active - Recruiting

  • Ospedale S. Giuseppe Multimedica

    Milano, Lombardia 20123
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi

    Ancona, Marche 60020
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, Piemonte 10126
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

    Catania, Sicilia 95123
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Toscana 50134
    Italy

    Active - Recruiting

  • Gachon University Gil Medical Center

    Incheon, 21565
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center - PPDS

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Hanyang University Medical Center

    Seoul, 04763
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center - PPDS

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea Eunpyeong St. Mary's Hospital

    Seoul, 03312
    Korea, Republic of

    Active - Recruiting

  • CICUM San Miguel

    Americana, Jalisco 44160
    Mexico

    Active - Recruiting

  • Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable - PPDS

    Guadalajara, Jalisco CP 44160
    Mexico

    Active - Recruiting

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo LEON
    Mexico

    Active - Recruiting

  • Christchurch Hospital

    Christchurch, 8011
    New Zealand

    Completed

  • Dunedin Hospital

    Dunedin,
    New Zealand

    Active - Recruiting

  • Waikato Hospital

    Hamilton, 3248
    New Zealand

    Active - Recruiting

  • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

    Lodz, 90-153
    Poland

    Active - Recruiting

  • EMED Centrum Uslug Medycznych Ewa Smialek

    Rzeszow, 35-205
    Poland

    Active - Recruiting

  • EMED Centrum Uslug Medycznych Ewa Smialek

    Rzeszów, 35-205
    Poland

    Site Not Available

  • PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna

    Sosnowiec, 41-208
    Poland

    Active - Recruiting

  • Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy

    Warszawa, 04-141
    Poland

    Active - Recruiting

  • Dr JM Engelbrecht Trial site

    Cape Town, 7130
    South Africa

    Active - Recruiting

  • University of Cape Town Lung Institute UCTLI

    Cape Town, 7700
    South Africa

    Active - Recruiting

  • Panorama Medical Centre

    City Of Cape Town, 7500
    South Africa

    Site Not Available

  • St Augustines Hospital

    Durban, 4001
    South Africa

    Active - Recruiting

  • Hospital Universitario de Bellvitge

    Hospitalet de Llobregat, Barcelona 08907
    Spain

    Active - Recruiting

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria 39008
    Spain

    Active - Recruiting

  • CHUS H Clinico U de Santiago

    Santiago de Compostela, LA Coruna 15706
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria

    Malaga, 29010
    Spain

    Active - Recruiting

  • Hospital Universitario Son Espases

    Palma de Mallorca, 07120
    Spain

    Active - Recruiting

  • Far East Memorial Hospital

    New Taipei, 220
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei City, 11217
    Taiwan

    Active - Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Banner University Medicine Lung Institute

    Phoenix, Arizona 85006-2506
    United States

    Active - Recruiting

  • Southern Arizona VA Health Care System NAVREF PPDS

    Tucson, Arizona 85723-0001
    United States

    Active - Recruiting

  • University of California, San Francisco-Fresno

    Fresno, California 93701-2302
    United States

    Active - Recruiting

  • UCLA Rheumatology

    Los Angeles, California 90095-8344
    United States

    Active - Recruiting

  • University of Southern California Keck School of Medicine

    Los Angeles, California 90033-1036
    United States

    Active - Recruiting

  • University of California, San Francisco Medical Center

    San Francisco, California 94143-2204
    United States

    Active - Recruiting

  • The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente

    Torrance, California 90502
    United States

    Site Not Available

  • Renstar Medical Research

    Ocala, Florida 34470
    United States

    Active - Recruiting

  • Central Florida Pulmonary Group, PA

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Coastal Pulmonary and Critical Care PLC

    Saint Petersburg, Florida 33704-2733
    United States

    Active - Recruiting

  • Weston Hospital

    Weston, Florida 33331-3609
    United States

    Active - Recruiting

  • Piedmont Pulmonary and Sleep Medicine Buckhead

    Atlanta, Georgia 30309-1740
    United States

    Active - Recruiting

  • GenHarp Clinical Solutions

    Evergreen Park, Illinois 60805-2758
    United States

    Active - Recruiting

  • Northwestern Medicine - Northwestern Medicine Glen

    Glenview, Illinois 60026-8039
    United States

    Active - Recruiting

  • IU Health Ball Memorial Physicians Pulmonary and Critical Care Medicine

    Muncie, Indiana 47303-3432
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • University of Michigan Hospital

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Hannibal Clinic

    Hannibal, Missouri 63401
    United States

    Active - Recruiting

  • Hannibal Regional Healthcare System HRMG Hannibal

    Hannibal, Missouri 63401-6890
    United States

    Active - Recruiting

  • Pulmonix LLC

    Greensboro, North Carolina 27403-4443
    United States

    Active - Recruiting

  • Southeastern Research Center

    Winston-Salem, North Carolina 27103-4029
    United States

    Active - Recruiting

  • The University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104-5417
    United States

    Active - Recruiting

  • Baylor Scott and White Health - Advanced Lung Disease Specialists - Dallas

    Dallas, Texas 75246-2073
    United States

    Active - Recruiting

  • IntraCare Health Center ? Prestige

    Dallas, Texas 75254
    United States

    Active - Recruiting

  • El Paso Pulmonary Association Elligo PPDS

    El Paso, Texas 79902-1124
    United States

    Active - Recruiting

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Active - Recruiting

  • McGovern Medical School

    Houston, Texas 77030-1501
    United States

    Active - Recruiting

  • Research Centers of America

    McKinney, Texas 75071-7824
    United States

    Site Not Available

  • University of Utah - PPDS

    Salt Lake City, Utah 84108-1287
    United States

    Active - Recruiting

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