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Experimental drug vixarelimab tested for two scarring lung diseases

NCT ID NCT05785624

Disease control Sponsor: Genentech, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the drug vixarelimab against a placebo in people with idiopathic pulmonary fibrosis (IPF) or systemic sclerosis-associated interstitial lung disease (SSc-ILD). The goal was to see if it could preserve lung function over 52 weeks. The trial was terminated early, but some participants had already enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vixarelimab
What this could lead to
If successful, vixarelimab could offer a new treatment option to slow lung function decline in people with IPF or SSc-ILD.
What could go wrong
This is an early-phase (Phase 2) trial that was terminated, so results may be incomplete. The drug may not improve lung function or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

286 people

The number who actually took part.

Started

May 2023

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis pulmonary systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic pulmonary fibrosis Systemic sclerosis with lung involvement

Contacts and locations

Locations

  • AZORG Campus Aalst-Moorselbaan

    Aalst, 9300, Belgium

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, Emilia-Romagna, 42100, Italy

  • Asan Medical Center - PPDS

    Seoul, 05505, South Korea

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Turin, Piedmont, 10126, Italy

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

    Catania, Sicily, 95123, Italy

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Tuscany, 50134, Italy

  • Azienda Ospedaliera Universitaria Senese

    Siena, Abruzzo, 53100, Italy

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

    Ancona, The Marches, 60020, Italy

  • Banner University Medicine Lung Institute

    Phoenix, Arizona, 85006-2506, United States

  • Barzilai Medical Center

    Ashkelon, 7830604, Israel

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

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

    Dallas, Texas, 75246-2073, United States

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

    Guadalajara, Jalisco, CP 44160, Mexico

  • CEC SpA

    Ñuñoa, 7750495, Chile

  • CHU de Liège

    Liège, 4000, Belgium

  • CHU de Reims

    Reims, 51100, France

  • CHUS H Clinico U de Santiago

    Santiago de Compostela, LA Coruna, 15706, Spain

  • CICUM San Miguel

    Americana, Jalisco, 44160, Mexico

  • Centro Médico Dra de Salvo

    Buenos Aires, C1426ABP, Argentina

  • Centro de Investigacion del Maule

    Talca, 3481349, Chile

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, T4000AXL, Argentina

  • Centro de Investigaciones Reumatologicas

    San Miguel de Tucumán, T4000AXL, Argentina

  • Christchurch Hospital

    Christchurch, 8011, New Zealand

  • Coastal Pulmonary and Critical Care PLC

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

  • Consultorios Médicos Dr. Doreski

    Ciudad Autonoma Buenos Aires, C1426ABP, Argentina

  • Dr Anil Dhar Professional Medicine Corporation

    Windsor, Ontario, N8X 5A6, Canada

  • Dr JM Engelbrecht Trial site

    Cape Town, 7130, South Africa

  • Dunedin Hospital

    Dunedin, New Zealand

  • Dynamic Drug Advancement Ltd.

    Ajax, Ontario, L1S 2J5, Canada

  • EMED Centrum Uslug Medycznych Ewa Smialek

    Rzeszów, 35-205, Poland

  • El Paso Pulmonary Association Elligo PPDS

    El Paso, Texas, 79902-1124, United States

  • Emory Clinic

    Atlanta, Georgia, 30322, United States

  • Enroll SpA - PPDS

    Providencia, 7500587, Chile

  • Evangelische Lungenklinik Berlin

    Berlin, 13125, Germany

  • Far East Memorial Hospital

    New Taipei City, 220, Taiwan

  • Fondazione Policlinico Universitario A Gemelli

    Rome, Lazio, 00168, Italy

  • Fundacion Scherbovsky

    Mendoza, 5500, Argentina

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • GenHarp Clinical Solutions

    Evergreen Park, Illinois, 60805-2758, United States

  • Groupe Hospitalier Bichat Claude Bernard

    Paris, 75018, France

  • Hadassah Medical Center

    Jerusalem, 9112001, Israel

  • Hannibal Regional Healthcare System HRMG Hannibal

    Hannibal, Missouri, 63401-6890, United States

  • Hanyang University Medical Center

    Seoul, 04763, South Korea

  • Hopital Avicenne

    Bobigny, 93000, France

  • Hopital Louis Pradel

    Bron, 69677, France

  • Hopital Nord AP-HM

    Marseille, 13015, France

  • Hopital Pasteur 2

    Nice, 06001, France

  • Hospital Brasilia

    Brasília, Federal District, 71635580, Brazil

  • Hospital Clinic de Barcelona

    Barcelona, 8036, Spain

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Dia do Pulmao

    Blumenau, Santa Catarina, 89030-101, Brazil

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007, Spain

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo León, Mexico

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Son Espases

    Palma de Mallorca, 07120, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Hospital de Clinicas de Porto Alegre HCPA PPDS

    Porto Alegre, Pará, 90035-903, Brazil

  • Hôpital Arnaud de Villeneuve

    Montpellier, 34295, France

  • INSARES

    Mendoza, Mendoza City, M5500CCG, Argentina

  • IU Health Ball Memorial Physicians Pulmonary and Critical Care Medicine

    Muncie, Indiana, 47303-3432, United States

  • Instituto Ave Pulmo

    Mar del Plata, B7602DCK, Argentina

  • Instituto De Patologias Respiratorias

    San Miguel de Tucumán, 4000, Argentina

  • Instituto Del Buen Aire

    Santa Fe, 3000, Argentina

  • Instituto Medico Rio Cuarto

    Río Cuarto, 5800, Argentina

  • Instituto Medico de la Fundacion Estudios Clinicos

    Rosario, S2013DTC, Argentina

  • IntraCare Health Center ? Prestige

    Dallas, Texas, 75254, United States

  • Kaplan Medical Center

    Rehovot, 7610001, Israel

  • Kelowna Allergy and Respiratory Health Clinic

    Kelowna, British Columbia, V1W 1V3, Canada

  • L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME

    Brasília, Federal District, 70200-730, Brazil

  • Lady Davis Carmel Medical Center

    Haifa, 34362, Israel

  • McGovern Medical School

    Houston, Texas, 77030-1501, United States

  • Monash Health Monash Medical Centre

    Clayton, Victoria, 3168, Australia

  • Northwestern Medicine - Northwestern Medicine Glen

    Glenview, Illinois, 60026-8039, United States

  • Ospedale S. Giuseppe Multimedica

    Milan, Lombardy, 20123, Italy

  • PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna

    Sosnowiec, 41-208, Poland

  • Piedmont Pulmonary and Sleep Medicine Buckhead

    Atlanta, Georgia, 30309-1740, United States

  • Presidio Ospedaliero GB Morgagni L Pierantoni

    Forlì, Emilia-Romagna, 47121, Italy

  • Pulmonix LLC

    Greensboro, North Carolina, 27403-4443, United States

  • Rabin Medical Center

    Petah Tikva, 52621, Israel

  • Rambam Medical Center

    Haifa, 3109601, Israel

  • Renstar Medical Research

    Ocala, Florida, 34470, United States

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050, Australia

  • Ruhrlandklinik

    Essen, 45239, Germany

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

    Lodz, 90-153, Poland

  • Samsung Medical Center - PPDS

    Seoul, 06351, South Korea

  • Shamir Medical Center Assaf Harofeh

    Beer Jacob, 0073100, Israel

  • Southeastern Research Center

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

  • Southern Arizona VA Health Care System NAVREF PPDS

    Tucson, Arizona, 85723-0001, United States

  • St Augustines Hospital

    Durban, 4001, South Africa

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010, Australia

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tel Aviv Sourasky Medical Center PPDS

    Tel Aviv, 6423906, Israel

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

    Seoul, 03312, South Korea

  • The Chaim Sheba Medical Center

    Ramat Gan, 5262100, Israel

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

    Torrance, California, 90502, United States

  • The University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104-5417, United States

  • UCLA Rheumatology

    Los Angeles, California, 90095-8344, United States

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, 40225, Germany

  • University General Hospital of Heraklion

    Heraklion, 711 10, Greece

  • University General Hospital of Larissa

    Larissa, 412 21, Greece

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of California, San Francisco Medical Center

    San Francisco, California, 94143-2204, United States

  • University of California, San Francisco-Fresno

    Fresno, California, 93701-2302, United States

  • University of Cape Town Lung Institute UCTLI

    Cape Town, 7700, South Africa

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Michigan Hospital

    Ann Arbor, Michigan, 48109, United States

  • University of Southern California Keck School of Medicine

    Los Angeles, California, 90033-1036, United States

  • University of Utah - PPDS

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

  • Waikato Hospital

    Hamilton, 3248, New Zealand

  • Weston Hospital

    Weston, Florida, 33331-3609, United States

  • Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy

    Warsaw, 04-141, Poland

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