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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

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 progressive 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.
  • - 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.
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 by 12% and 200 milliliters [mL]) - 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 anti-fibrotic treatment (e.g., nintedanib) within 4 weeks prior to screening.
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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05785624
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Genentech, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Trials
Principal Investigator Affiliation Hoffmann-La Roche
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Australia, Belgium, Brazil, Canada, Chile, France, Greece, Israel, Italy, Korea, Republic of, New Zealand, Poland, South Africa, Spain, Taiwan, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis, Systemic Sclerosis With Lung Involvement
Arms & Interventions

Arms

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.

Placebo Comparator: DBT: Cohort 1: Placebo

Participants with IPF will receive vixarelimab matching placebo, SC, Q2W for 52 weeks in the DBT period.

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.

Interventions

Drug: - Vixarelimab

Vixarelimab will be administered as per the schedule specified in the respective arms.

Drug: - Placebo

Placebo will be administered as per the schedule specified in the respective arms.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300

Fresno, California

Status

Recruiting

Address

University of California, San Francisco-Fresno

Fresno, California, 93701

San Francisco, California

Status

Recruiting

Address

University of California, San Francisco Medical Center

San Francisco, California, 94115

Renstar Medical Research, Ocala, Florida

Status

Recruiting

Address

Renstar Medical Research

Ocala, Florida, 34470

Central Florida Pulmonary Group, PA, Orlando, Florida

Status

Recruiting

Address

Central Florida Pulmonary Group, PA

Orlando, Florida, 32803

Coastal Pulmonary and Critical Care PLC, Saint Petersburg, Florida

Status

Recruiting

Address

Coastal Pulmonary and Critical Care PLC

Saint Petersburg, Florida, 33704-2733

Glenview, Illinois

Status

Recruiting

Address

Northwestern Medicine - Northwestern Medicine Glen

Glenview, Illinois, 60026-8039

Muncie, Indiana

Status

Recruiting

Address

IU Health Ball Memorial Physicians Pulmonary and Critical Care Medicine

Muncie, Indiana, 47303-3432

University of Kansas Medical Center, Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Medical Center

Kansas City, Kansas, 66160

Hannibal, Missouri

Status

Recruiting

Address

Hannibal Regional Healthcare System HRMG Hannibal

Hannibal, Missouri, 63401-6890

Pulmonix LLC, Greensboro, North Carolina

Status

Recruiting

Address

Pulmonix LLC

Greensboro, North Carolina, 27403

Southeastern Research Center, Winston-Salem, North Carolina

Status

Recruiting

Address

Southeastern Research Center

Winston-Salem, North Carolina, 27103-4029

El Paso, Texas

Status

Recruiting

Address

El Paso Pulmonary Association Elligo PPDS

El Paso, Texas, 79902-1124

McGovern Medical School, Houston, Texas

Status

Recruiting

Address

McGovern Medical School

Houston, Texas, 77030-1501

Research Centers of America, McKinney, Texas

Status

Recruiting

Address

Research Centers of America

McKinney, Texas, 75071-7824

International Sites

Centro Médico Dra de Salvo, Buenos Aires, Argentina

Status

Recruiting

Address

Centro Médico Dra de Salvo

Buenos Aires, , C1426ABP

Instituto Medico Rio Cuarto, Cordoba, Argentina

Status

Recruiting

Address

Instituto Medico Rio Cuarto

Cordoba, , X5800AEU

Instituto Ave Pulmo, Mar Del Plata, Argentina

Status

Recruiting

Address

Instituto Ave Pulmo

Mar Del Plata, , B7602DCK

Fundacion Scherbovsky, Mendoza, Argentina

Status

Recruiting

Address

Fundacion Scherbovsky

Mendoza, , M5500AYB

Centro de Investigaciones Reumatologicas, San Miguel de Tucuman, Argentina

Status

Recruiting

Address

Centro de Investigaciones Reumatologicas

San Miguel de Tucuman, , T4000AXL

Instituto De Patologias Respiratorias, San Miguel de Tucuman, Argentina

Status

Recruiting

Address

Instituto De Patologias Respiratorias

San Miguel de Tucuman, , T4000IAJ

Instituto Del Buen Aire, Santa Fe, Argentina

Status

Recruiting

Address

Instituto Del Buen Aire

Santa Fe, , 3000

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Status

Recruiting

Address

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050

St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia

Status

Recruiting

Address

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010

Onze Lieve Vrouwziekenhuis Aalst, Aalst, Belgium

Status

Recruiting

Address

Onze Lieve Vrouwziekenhuis Aalst

Aalst, , 9300

CHU de Liège, Liège, Belgium

Status

Recruiting

Address

CHU de Liège

Liège, , 4000

AZ Delta, Roeselare, Belgium

Status

Recruiting

Address

AZ Delta

Roeselare, , 8800

Brasilia, DF, Brazil

Status

Recruiting

Address

L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME

Brasilia, DF, 70200-730

Porto Alegre, PA, Brazil

Status

Recruiting

Address

Hospital de Clinicas de Porto Alegre HCPA PPDS

Porto Alegre, PA, 90035-903

Hospital Dia do Pulmao, Blumenau, SC, Brazil

Status

Recruiting

Address

Hospital Dia do Pulmao

Blumenau, SC, 89030-101

Kelowna, British Columbia, Canada

Status

Recruiting

Address

Kelowna Allergy and Respiratory Health Clinic

Kelowna, British Columbia, V1W 1V3

Dynamic Drug Advancement Ltd., Ajax, Ontario, Canada

Status

Recruiting

Address

Dynamic Drug Advancement Ltd.

Ajax, Ontario, L1S 2J5

CEC SpA, Nunoa, Chile

Status

Recruiting

Address

CEC SpA

Nunoa, , 7750000

Enroll SpA - PPDS, Providencia, Chile

Status

Recruiting

Address

Enroll SpA - PPDS

Providencia, , 7500587

Centro de Investigacion del Maule, Talca, Chile

Status

Recruiting

Address

Centro de Investigacion del Maule

Talca, ,

Hopital Avicenne, Bobigny, France

Status

Recruiting

Address

Hopital Avicenne

Bobigny, , 93000

Hopital Louis Pradel, Bron, France

Status

Recruiting

Address

Hopital Louis Pradel

Bron, , 69677

Hopital Nord AP-HM, Marseille, France

Status

Recruiting

Address

Hopital Nord AP-HM

Marseille, , 13015

Hôpital Arnaud de Villeneuve, Montpellier, France

Status

Recruiting

Address

Hôpital Arnaud de Villeneuve

Montpellier, , 34295

Hopital Pasteur 2, Nice Cedex 1, France

Status

Recruiting

Address

Hopital Pasteur 2

Nice Cedex 1, , 06001

Groupe Hospitalier Bichat Claude Bernard, Paris, France

Status

Recruiting

Address

Groupe Hospitalier Bichat Claude Bernard

Paris, , 75018

CHU de Reims, Reims, France

Status

Recruiting

Address

CHU de Reims

Reims, , 51100

University General Hospital of Heraklion, Heraklio, Greece

Status

Recruiting

Address

University General Hospital of Heraklion

Heraklio, , 711 10

University General Hospital of Larissa, Larissa, Greece

Status

Recruiting

Address

University General Hospital of Larissa

Larissa, , 412 21

Barzilai Medical Center, Ashkelon, Israel

Status

Recruiting

Address

Barzilai Medical Center

Ashkelon, , 7830604

Shamir Medical Center Assaf Harofeh, Beer Jacob, Israel

Status

Recruiting

Address

Shamir Medical Center Assaf Harofeh

Beer Jacob, , 0073100

Rambam Medical Center, Haifa, Israel

Status

Recruiting

Address

Rambam Medical Center

Haifa, , 3109601

Lady Davis Carmel Medical Center, Haifa, Israel

Status

Recruiting

Address

Lady Davis Carmel Medical Center

Haifa, , 34362

Hadassah Medical Center, Jerusalem, Israel

Status

Recruiting

Address

Hadassah Medical Center

Jerusalem, , 9112001

Rabin Medical Center, Petah Tikva, Israel

Status

Recruiting

Address

Rabin Medical Center

Petah Tikva, , 52621

Sheba Medical Center - PPDS, Ramat-Gan, Israel

Status

Recruiting

Address

Sheba Medical Center - PPDS

Ramat-Gan, , 5262000

Kaplan Medical Center, Rehovot, Israel

Status

Recruiting

Address

Kaplan Medical Center

Rehovot, , 7610001

Tel Aviv Sourasky Medical Center PPDS, Tel Aviv-Yafo, Israel

Status

Recruiting

Address

Tel Aviv Sourasky Medical Center PPDS

Tel Aviv-Yafo, , 6423906

Azienda Ospedaliera Universitaria Senese, Siena, Abruzzo, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria Senese

Siena, Abruzzo, 53100

Forli', Emilia-Romagna, Italy

Status

Recruiting

Address

Presidio Ospedaliero GB Morgagni L Pierantoni

Forli', Emilia-Romagna, 47121

Torino, Piemonte, Italy

Status

Recruiting

Address

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Torino, Piemonte, 10126

Catania, Sicilia, Italy

Status

Recruiting

Address

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

Catania, Sicilia, 95123

Florence, Toscana, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria Careggi

Florence, Toscana, 50134

Gachon University Gil Medical Center, Incheon, Korea, Republic of

Status

Recruiting

Address

Gachon University Gil Medical Center

Incheon, , 21565

Seoul, Korea, Republic of

Status

Recruiting

Address

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

Seoul, , 03312

Hanyang University Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Hanyang University Medical Center

Seoul, , 04763

Samsung Medical Center - PPDS, Seoul, Korea, Republic of

Status

Recruiting

Address

Samsung Medical Center - PPDS

Seoul, , 06351

Christchurch Hospital, Christchurch, New Zealand

Status

Recruiting

Address

Christchurch Hospital

Christchurch, , 8011

Dunedin Hospital, Dunedin, New Zealand

Status

Recruiting

Address

Dunedin Hospital

Dunedin, ,

Waikato Hospital, Hamilton, New Zealand

Status

Recruiting

Address

Waikato Hospital

Hamilton, , 3248

Rzeszów, Poland

Status

Recruiting

Address

EMED Centrum Uslug Medycznych Ewa Smialek

Rzeszów, , 35-205

Sosnowiec, Poland

Status

Recruiting

Address

PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna

Sosnowiec, , 41-200

Dr JM Engelbrecht Trial site, Cape Town, South Africa

Status

Recruiting

Address

Dr JM Engelbrecht Trial site

Cape Town, , 7130

St Augustines Hospital, Durban, South Africa

Status

Recruiting

Address

St Augustines Hospital

Durban, , 4001

Santander, Cantabria, Spain

Status

Recruiting

Address

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008

Hospital Universitario Son Espases, Palma de Mallorca, Islas Baleares, Spain

Status

Recruiting

Address

Hospital Universitario Son Espases

Palma de Mallorca, Islas Baleares, 07120

CHUS H Clinico U de Santiago, Santiago de Compostela, LA Coruña, Spain

Status

Recruiting

Address

CHUS H Clinico U de Santiago

Santiago de Compostela, LA Coruña, 15706

Hospital Clinic de Barcelona, Barcelona, Spain

Status

Recruiting

Address

Hospital Clinic de Barcelona

Barcelona, , 08036

Hospital Clinico San Carlos, Madrid, Spain

Status

Recruiting

Address

Hospital Clinico San Carlos

Madrid, , 28040

Malaga, Spain

Status

Recruiting

Address

Hospital Universitario Virgen de la Victoria

Malaga, , 29010

Far East Memorial Hospital, New Taipei, Taiwan

Status

Recruiting

Address

Far East Memorial Hospital

New Taipei, , 220

Taipei Veterans General Hospital, Taipei City, Taiwan

Status

Recruiting

Address

Taipei Veterans General Hospital

Taipei City, , 11217

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