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

NCT05785624 | Terminated Phase 2 DMC FDA Drug

• 3 other identifiers: GB444962022-502828-422022-502828-42-00
• Study Type: interventional
• Target: 286
• Locations: 19 countries
• Sites: 114

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.

Conditions

Idiopathic Pulmonary Fibrosis; Systemic Sclerosis With Lung Involvement

Keywords

Systemic Sclerosis-Associated Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

• Cohorts 1 and 2: Absolute Change From Baseline in Forced Vital Capacity (FVC)

  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.

  Baseline up to Week 52

Secondary Outcomes (15)

• Cohorts 1 and 2: Absolute Change From Baseline in 6-Minute Walk Test (6MWT) Distance

  Baseline up to Week 52

• Cohorts 1 and 2: Absolute Change From Baseline in Percentage of Predicted FVC

  Baseline up to Week 52

• 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

• 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)

• 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)

Study Arms (6)

DBT: Cohort 1: Vixarelimab

EXPERIMENTAL

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.

Drug: Vixarelimab

DBT: Cohort 1: Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

DBT: Cohort 2: Vixarelimab

EXPERIMENTAL

Participants with SSC-ILD will receive vixarelimab, SC, Q2W for 52 weeks in the DBT period.

Drug: Vixarelimab

DBT: Cohort 2: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

OLE Period: Cohort 1: Vixarelimab

EXPERIMENTAL

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.

Drug: Vixarelimab

OLE Period: Cohort 2: Vixarelimab

EXPERIMENTAL

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.

Drug: Vixarelimab

Interventions

Vixarelimab DRUG

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

Also known as: RO7622888, KPL-716

DBT: Cohort 1: Vixarelimab; DBT: Cohort 2: Vixarelimab; OLE Period: Cohort 1: Vixarelimab; OLE Period: Cohort 2: Vixarelimab

Placebo DRUG

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

DBT: Cohort 1: Placebo; DBT: Cohort 2: Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (114)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Banner University Medicine Lung Institute

Phoenix, Arizona, 85006-2506, United States

Location

Southern Arizona VA Health Care System NAVREF PPDS

Tucson, Arizona, 85723-0001, United States

Location

University of California, San Francisco-Fresno

Fresno, California, 93701-2302, United States

Location

University of Southern California Keck School of Medicine

Los Angeles, California, 90033-1036, United States

Location

UCLA Rheumatology

Los Angeles, California, 90095-8344, United States

Location

University of California, San Francisco Medical Center

San Francisco, California, 94143-2204, United States

Location

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

Torrance, California, 90502, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Coastal Pulmonary and Critical Care PLC

St. Petersburg, Florida, 33704-2733, United States

Location

Weston Hospital

Weston, Florida, 33331-3609, United States

Location

Piedmont Pulmonary and Sleep Medicine Buckhead

Atlanta, Georgia, 30309-1740, United States

Location

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

GenHarp Clinical Solutions

Evergreen Park, Illinois, 60805-2758, United States

Location

Northwestern Medicine - Northwestern Medicine Glen

Glenview, Illinois, 60026-8039, United States

Location

IU Health Ball Memorial Physicians Pulmonary and Critical Care Medicine

Muncie, Indiana, 47303-3432, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

Hannibal Regional Healthcare System HRMG Hannibal

Hannibal, Missouri, 63401-6890, United States

Location

Pulmonix LLC

Greensboro, North Carolina, 27403-4443, United States

Location

Southeastern Research Center

Winston-Salem, North Carolina, 27103-4029, United States

Location

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104-5417, United States

Location

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

Dallas, Texas, 75246-2073, United States

Location

IntraCare Health Center ? Prestige

Dallas, Texas, 75254, United States

Location

El Paso Pulmonary Association Elligo PPDS

El Paso, Texas, 79902-1124, United States

Location

McGovern Medical School

Houston, Texas, 77030-1501, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Utah - PPDS

Salt Lake City, Utah, 84108-1287, United States

Location

Centro Médico Dra de Salvo

Buenos Aires, C1426ABP, Argentina

Location

Consultorios Médicos Dr. Doreski

Ciudad Autonoma Buenos Aires, C1426ABP, Argentina

Location

Instituto Ave Pulmo

Mar del Plata, B7602DCK, Argentina

Location

Fundacion Scherbovsky

Mendoza, 5500, Argentina

Location

INSARES

Mendoza, Mendoza City, M5500CCG, Argentina

Location

Instituto Medico Rio Cuarto

Río Cuarto, 5800, Argentina

Location

Instituto Medico de la Fundacion Estudios Clinicos

Rosario, S2013DTC, Argentina

Location

Instituto De Patologias Respiratorias

San Miguel de Tucumán, 4000, Argentina

Location

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, T4000AXL, Argentina

Location

Centro de Investigaciones Reumatologicas

San Miguel de Tucumán, T4000AXL, Argentina

Location

Instituto Del Buen Aire

Santa Fe, 3000, Argentina

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

Location

Monash Health Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

AZORG Campus Aalst-Moorselbaan

Aalst, 9300, Belgium

Location

CHU de Liège

Liège, 4000, Belgium

Location

L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME

Brasília, Federal District, 70200-730, Brazil

Location

Hospital Brasilia

Brasília, Federal District, 71635580, Brazil

Location

Hospital de Clinicas de Porto Alegre HCPA PPDS

Pôrto Alegre, Pará, 90035-903, Brazil

Location

Hospital Dia do Pulmao

Blumenau, Santa Catarina, 89030-101, Brazil

Location

Kelowna Allergy and Respiratory Health Clinic

Kelowna, British Columbia, V1W 1V3, Canada

Location

Dynamic Drug Advancement Ltd.

Ajax, Ontario, L1S 2J5, Canada

Location

Dr Anil Dhar Professional Medicine Corporation

Windsor, Ontario, N8X 5A6, Canada

Location

CEC SpA

Ñuñoa, 7750495, Chile

Location

Enroll SpA - PPDS

Providencia, 7500587, Chile

Location

Centro de Investigacion del Maule

Talca, 3481349, Chile

Location

Hopital Avicenne

Bobigny, 93000, France

Location

Hopital Louis Pradel

Bron, 69677, France

Location

Hopital Nord AP-HM

Marseille, 13015, France

Location

Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Hopital Pasteur 2

Nice, 06001, France

Location

Groupe Hospitalier Bichat Claude Bernard

Paris, 75018, France

Location

CHU de Reims

Reims, 51100, France

Location

Evangelische Lungenklinik Berlin

Berlin, 13125, Germany

Location

Universitaetsklinikum Duesseldorf

Düsseldorf, 40225, Germany

Location

Ruhrlandklinik

Essen, 45239, Germany

Location

University General Hospital of Heraklion

Heraklion, 711 10, Greece

Location

University General Hospital of Larissa

Larissa, 412 21, Greece

Location

Barzilai Medical Center

Ashkelon, 7830604, Israel

Location

Shamir Medical Center Assaf Harofeh

Beer Jacob, 0073100, Israel

Location

Rambam Medical Center

Haifa, 3109601, Israel

Location

Lady Davis Carmel Medical Center

Haifa, 34362, Israel

Location

Hadassah Medical Center

Jerusalem, 9112001, Israel

Location

Rabin Medical Center

Petah Tikva, 52621, Israel

Location

The Chaim Sheba Medical Center

Ramat Gan, 5262100, Israel

Location

Kaplan Medical Center

Rehovot, 7610001, Israel

Location

Tel Aviv Sourasky Medical Center PPDS

Tel Aviv, 6423906, Israel

Location

Azienda Ospedaliera Universitaria Senese

Siena, Abruzzo, 53100, Italy

Location

Presidio Ospedaliero GB Morgagni L Pierantoni

Forlì, Emilia-Romagna, 47121, Italy

Location

Arcispedale Santa Maria Nuova

Reggio Emilia, Emilia-Romagna, 42100, Italy

Location

Fondazione Policlinico Universitario A Gemelli

Rome, Lazio, 00168, Italy

Location

Ospedale S. Giuseppe Multimedica

Milan, Lombardy, 20123, Italy

Location

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Turin, Piedmont, 10126, Italy

Location

Azienda Ospedaliera Universitaria "Policlinico - Vittorio Emanuele" (Presidio Gaspare Rodolico)

Catania, Sicily, 95123, Italy

Location

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

Ancona, The Marches, 60020, Italy

Location

Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, 50134, Italy

Location

CICUM San Miguel

Americana, Jalisco, 44160, Mexico

Location

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

Guadalajara, Jalisco, CP 44160, Mexico

Location

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo León, Mexico

Location

Christchurch Hospital

Christchurch, 8011, New Zealand

Location

Dunedin Hospital

Dunedin, New Zealand

Location

Waikato Hospital

Hamilton, 3248, New Zealand

Location

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

Lodz, 90-153, Poland

Location

EMED Centrum Uslug Medycznych Ewa Smialek

Rzeszów, 35-205, Poland

Location

PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna

Sosnowiec, 41-208, Poland

Location

Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy

Warsaw, 04-141, Poland

Location

Dr JM Engelbrecht Trial site

Cape Town, 7130, South Africa

Location

University of Cape Town Lung Institute UCTLI

Cape Town, 7700, South Africa

Location

St Augustines Hospital

Durban, 4001, South Africa

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

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

Seoul, 03312, South Korea

Location

Hanyang University Medical Center

Seoul, 04763, South Korea

Location

Asan Medical Center - PPDS

Seoul, 05505, South Korea

Location

Samsung Medical Center - PPDS

Seoul, 06351, South Korea

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

CHUS H Clinico U de Santiago

Santiago de Compostela, LA Coruna, 15706, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 8036, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, 07120, Spain

Location

Far East Memorial Hospital

New Taipei City, 220, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 27, 2023
• Study Start: May 26, 2023
• Primary Completion: January 12, 2026
• Study Completion: January 12, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

DE (3); ME (3); NZ (3); AU (3); IT (9); CA (3); BE (2); ZA (3); KR (5); GR (2); ES (9); PL (4); AR (11); BR (4); IL (9); FR (7); TW (3); CL (3); US (28)