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Idiopathic Pulmonary FibrosisPhase 2NCT05785624

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

A Phase 2 study testing Vixarelimab in people with Idiopathic Pulmonary Fibrosis and Systemic Sclerosis With Lung Involvement, run by Genentech, Inc. at 114 sites in 19 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Vixarelimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
286 participants
Where
114 sitesin 19 countries
Study dates
26 May 2023to 12 Jan 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 18Show fewer
  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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
  • Receiving pirfenidone treatment within 4 weeks prior to screening
  • Receipt of nintedanib in combination with tocilizumab
  • 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 locations and contacts

114 sites in 19 countries.

114 sites in 19 countries

United States28 sites

  • University of Michigan Hospital

    Ann Arbor, Michigan, 48109

  • Piedmont Pulmonary and Sleep Medicine Buckhead

    Atlanta, Georgia, 30309-1740

  • Emory Clinic

    Atlanta, Georgia, 30322

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

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

    Dallas, Texas, 75246-2073

  • IntraCare Health Center ? Prestige

    Dallas, Texas, 75254

  • El Paso Pulmonary Association Elligo PPDS

    El Paso, Texas, 79902-1124

  • GenHarp Clinical Solutions

    Evergreen Park, Illinois, 60805-2758

  • University of California, San Francisco-Fresno

    Fresno, California, 93701-2302

  • Northwestern Medicine - Northwestern Medicine Glen

    Glenview, Illinois, 60026-8039

  • Pulmonix LLC

    Greensboro, North Carolina, 27403-4443

  • Hannibal Regional Healthcare System HRMG Hannibal

    Hannibal, Missouri, 63401-6890

  • McGovern Medical School

    Houston, Texas, 77030-1501

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • University of Southern California Keck School of Medicine

    Los Angeles, California, 90033-1036

  • UCLA Rheumatology

    Los Angeles, California, 90095-8344

  • IU Health Ball Memorial Physicians Pulmonary and Critical Care Medicine

    Muncie, Indiana, 47303-3432

  • Renstar Medical Research

    Ocala, Florida, 34470

  • The University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104-5417

  • Banner University Medicine Lung Institute

    Phoenix, Arizona, 85006-2506

  • University of Utah - PPDS

    Salt Lake City, Utah, 84108-1287

  • University of California, San Francisco Medical Center

    San Francisco, California, 94143-2204

  • Coastal Pulmonary and Critical Care PLC

    St. Petersburg, Florida, 33704-2733

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

    Torrance, California, 90502

  • Southern Arizona VA Health Care System NAVREF PPDS

    Tucson, Arizona, 85723-0001

  • Weston Hospital

    Weston, Florida, 33331-3609

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103-4029

Other trials in United States

Argentina11 sites

  • Centro Médico Dra de Salvo

    Buenos Aires, C1426ABP

  • Consultorios Médicos Dr. Doreski

    Ciudad Autonoma Buenos Aires, C1426ABP

  • Instituto Ave Pulmo

    Mar del Plata, B7602DCK

  • Fundacion Scherbovsky

    Mendoza, 5500

  • INSARES

    Mendoza, Mendoza City, M5500CCG

  • Instituto Medico Rio Cuarto

    Río Cuarto, 5800

  • Instituto Medico de la Fundacion Estudios Clinicos

    Rosario, S2013DTC

  • Instituto De Patologias Respiratorias

    San Miguel de Tucumán, 4000

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, T4000AXL

  • Centro de Investigaciones Reumatologicas

    San Miguel de Tucumán, T4000AXL

  • Instituto Del Buen Aire

    Santa Fe, 3000

Other trials in Argentina

Israel9 sites

  • Barzilai Medical Center

    Ashkelon, 7830604

  • Shamir Medical Center Assaf Harofeh

    Beer Jacob, 0073100

  • Rambam Medical Center

    Haifa, 3109601

  • Lady Davis Carmel Medical Center

    Haifa, 34362

  • Hadassah Medical Center

    Jerusalem, 9112001

  • Rabin Medical Center

    Petah Tikva, 52621

  • The Chaim Sheba Medical Center

    Ramat Gan, 5262100

  • Kaplan Medical Center

    Rehovot, 7610001

  • Tel Aviv Sourasky Medical Center PPDS

    Tel Aviv, 6423906

Other trials in Israel

Italy9 sites

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

    Ancona, The Marches, 60020

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

    Catania, Sicily, 95123

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Tuscany, 50134

  • Presidio Ospedaliero GB Morgagni L Pierantoni

    Forlì, Emilia-Romagna, 47121

  • Ospedale S. Giuseppe Multimedica

    Milan, Lombardy, 20123

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, Emilia-Romagna, 42100

  • Fondazione Policlinico Universitario A Gemelli

    Rome, Lazio, 00168

  • Azienda Ospedaliera Universitaria Senese

    Siena, Abruzzo, 53100

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Turin, Piedmont, 10126

Other trials in Italy

Spain9 sites

  • Hospital Clinic de Barcelona

    Barcelona, 8036

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitario Son Espases

    Palma de Mallorca, 07120

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • CHUS H Clinico U de Santiago

    Santiago de Compostela, LA Coruna, 15706

Other trials in Spain

France7 sites

  • Hopital Avicenne

    Bobigny, 93000

  • Hopital Louis Pradel

    Bron, 69677

  • Hopital Nord AP-HM

    Marseille, 13015

  • Hôpital Arnaud de Villeneuve

    Montpellier, 34295

  • Hopital Pasteur 2

    Nice, 06001

  • Groupe Hospitalier Bichat Claude Bernard

    Paris, 75018

  • CHU de Reims

    Reims, 51100

Other trials in France

South Korea5 sites

  • Gachon University Gil Medical Center

    Incheon, 21565

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

    Seoul, 03312

  • Hanyang University Medical Center

    Seoul, 04763

  • Asan Medical Center - PPDS

    Seoul, 05505

  • Samsung Medical Center - PPDS

    Seoul, 06351

Other trials in South Korea

Brazil4 sites

  • Hospital Dia do Pulmao

    Blumenau, Santa Catarina, 89030-101

  • L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME

    Brasília, Federal District, 70200-730

  • Hospital Brasilia

    Brasília, Federal District, 71635580

  • Hospital de Clinicas de Porto Alegre HCPA PPDS

    Porto Alegre, Pará, 90035-903

Other trials in Brazil

Poland4 sites

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

    Lodz, 90-153

  • EMED Centrum Uslug Medycznych Ewa Smialek

    Rzeszów, 35-205

  • PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna

    Sosnowiec, 41-208

  • Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy

    Warsaw, 04-141

Other trials in Poland

Australia3 sites

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Monash Health Monash Medical Centre

    Clayton, Victoria, 3168

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

Other trials in Australia

Canada3 sites

  • Dynamic Drug Advancement Ltd.

    Ajax, Ontario, L1S 2J5

  • Kelowna Allergy and Respiratory Health Clinic

    Kelowna, British Columbia, V1W 1V3

  • Dr Anil Dhar Professional Medicine Corporation

    Windsor, Ontario, N8X 5A6

Other trials in Canada

Chile3 sites

  • CEC SpA

    Ñuñoa, 7750495

  • Enroll SpA - PPDS

    Providencia, 7500587

  • Centro de Investigacion del Maule

    Talca, 3481349

Other trials in Chile

Germany3 sites

  • Evangelische Lungenklinik Berlin

    Berlin, 13125

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, 40225

  • Ruhrlandklinik

    Essen, 45239

Other trials in Germany

Mexico3 sites

  • CICUM San Miguel

    Americana, Jalisco, 44160

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

    Guadalajara, Jalisco, CP 44160

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo León

Other trials in Mexico

New Zealand3 sites

  • Christchurch Hospital

    Christchurch, 8011

  • Dunedin Hospital

    Dunedin

  • Waikato Hospital

    Hamilton, 3248

Other trials in New Zealand

South Africa3 sites

  • Dr JM Engelbrecht Trial site

    Cape Town, 7130

  • University of Cape Town Lung Institute UCTLI

    Cape Town, 7700

  • St Augustines Hospital

    Durban, 4001

Other trials in South Africa

Taiwan3 sites

  • Far East Memorial Hospital

    New Taipei City, 220

  • Taichung Veterans General Hospital

    Taichung, 40705

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Belgium2 sites

  • AZORG Campus Aalst-Moorselbaan

    Aalst, 9300

  • CHU de Liège

    Liège, 4000

Other trials in Belgium

Greece2 sites

  • University General Hospital of Heraklion

    Heraklion, 711 10

  • University General Hospital of Larissa

    Larissa, 412 21

Other trials in Greece

About this study

Official title: 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

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.

Being tested
Vixarelimab, Placebo
Keywords
Systemic Sclerosis-Associated Interstitial Lung Disease
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VixarelimabDrug

    Also called RO7622888, KPL-716

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

  • PlaceboDrug

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

Study groups in NCT05785624
Study groupRoleWhat they receive
DBT: Cohort 1: VixarelimabExperimentalParticipants 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.
Receives: Drug: Vixarelimab
DBT: Cohort 1: PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo
DBT: Cohort 2: VixarelimabExperimentalParticipants with SSC-ILD will receive vixarelimab, SC, Q2W for 52 weeks in the DBT period.
Receives: Drug: Vixarelimab
DBT: Cohort 2: PlaceboPlacebo comparatorParticipants with SSC-ILD will receive vixarelimab matching placebo, SC, Q2W for 52 weeks in the DBT period.
Receives: Drug: Placebo
OLE Period: Cohort 1: VixarelimabExperimentalParticipants 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.
Receives: Drug: Vixarelimab
OLE Period: Cohort 2: VixarelimabExperimentalParticipants 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.
Receives: Drug: Vixarelimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline up to Week 52

Secondary outcomes (15)

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

    The 6MWT test is performed indoors on a flat, straight corridor with a hard surface at least 30 meters (m) in length. 6MWT measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes. 6MWT measure will be calculated as the simple difference between baseline distance walked over 6 minutes and week 52 distance walked over 6 minutes as measured in meters.

    Measured: Baseline up to Week 52

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

    Measured: Baseline up to Week 52

  3. Cohorts 1 and 2: Change From Baseline in Diffusion Capacity of the Lung for Carbon Monoxide Adjusted for Hemoglobin (DLco [Hb])

    DLCO measures the ability of the lungs to transfer gas from inhaled air to the red blood cells in the blood. DLCO is adjusted for hemoglobin as small changes in hemoglobin concentration can affect the carbon monoxide transfer.

    Measured: Baseline up to Week 52

  4. Cohorts 1 and 2: Time to Disease Progression

    Time to disease progression is defined as time to first occurrence of ≥10% absolute decline in percentage of predicted FVC, ≥15% relative decline in 6MWT distance, lung transplantation, or death. FVC=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. 6MWT test is performed indoors on a flat, straight corridor with a hard surface at least 30 m in length. 6MWT measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes. 6MWT measure will be calculated as the simple difference between baseline distance walked over 6 minutes and week 52 distance walked over 6 minutes as measured in meters.

    Measured: From the start of study treatment until disease progression or death, whichever occurs first (up to Week 52 of DBT)

  5. Cohorts 1 and 2: Time to First Acute Exacerbation of ILD, or Suspected Acute Exacerbation of ILD

    Measured: From the start of study treatment until end of DBT (up to Week 52)

  6. Cohorts 1 and 2: Change From Baseline in Quantitative Lung Fibrosis on High-Resolution Computed Tomography (HRCT) Scan of the Thorax

    High-resolution computer tomography (HRCT) is a type of computed tomography (CT) with specific techniques to enhance image resolution. It is used in the diagnosis of various health problems, most commonly for lung disease. These images show cross sections (slices) through the lungs.

    Measured: Baseline up to Week 52

  7. Cohorts 1 and 2: Percentage of Participants with Deaths

    Measured: Up to Week 52

  8. Cohort 2: Change From Baseline in Skin Sclerosis Assessed Using Modified Rodnan Skin Score (mRSS)

    mRSS is a measure of skin thickness. Skin thickness will be assessed by the investigator by palpation across 17 different body sites and scored on a scale of 0 (normal) to 3 (severe skin thickening). The total score is the sum of the individual skin scores from all of these sites and ranges from 0 (normal) to 51 (severe thickening in all 17 areas) units. Higher scores indicate disease worsening.

    Measured: Baseline up to Week 52

  9. Cohorts 1 and 2: Change From Baseline in Health-Related Quality of Life (HRQoL) Measured Using King's Brief Interstitial Lung Disease (K-BILD) Questionnaire

    K-BILD is a questionnaire that assesses HRQoL in ILDs. It consists of 15 items grouped into psychological, breathlessness and activity, and chest symptom domains, each scored individually on a 7-point scale, with domain-level and total scores transformed 0-100, with higher scores indicating better quality of life. It uses a 2-week recall period.

    Measured: Baseline up to Week 52

  10. Cohorts 1 and 2: Change From Baseline in Cough Measured Using Living with Pulmonary Fibrosis (L-PF) Symptoms Cough Domain Score

    The L-PF symptoms module is a 23-item tool with domains capturing shortness of breath, cough, and energy symptoms using a 0-4 numeric response scale (NRS) response format and a 24-hour recall period. The cough scores ranges from 0 to 100 with higher scores indicating greater symptom burden/impairment.

    Measured: Baseline up to Week 52

  11. Cohorts 1 and 2: Change From Baseline in Dyspnea Measured Using L-PF Symptoms Dyspnea Domain Score

    The L-PF symptoms module is a 23-item tool with domains capturing shortness of breath, cough, and energy symptoms using a 0-4 NRS response format and a 24-hour recall period. L-PF Symptoms Dyspnea Domain score (dyspnea score) ranges from 0 to 100, with higher score indicating greater impairment.

    Measured: Baseline up to Week 52

  12. Cohort 2: Change From Baseline in Pruritus Measured Using the Five-Dimension Itch Scale (5-D Itch) Total Score

    The 5-D-Itch questionnaire that measures itch and its impact. It consists of 8 items organized into 5 domains (duration, degree, direction, disability, and distribution). Each domain is scored 1 to 5 with a total score ranging from 5 to 25 with higher scores indicating greater itch severity.

    Measured: Baseline up to Week 52

  13. Cohorts 1, 2 and OLE Period: Number of Participants With Adverse Events (AEs)

    Measured: Up to Week 52

  14. Cohorts 1 and 2: Serum Concentration of Vixarelimab

    Measured: Baseline up to Week 52

  15. Cohorts 1 and 2: Number of Participants With Anti-Drug Antibodies (ADAs) to Vixarelimab

    Measured: Baseline up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2023
  2. Study start26 May 2023
  3. Primary completion12 Jan 2026
  4. Study completion12 Jan 2026

Why it stopped: Sponsor decided to discontinue the study after review of clinical data by the iDMC. This decision was based on unblinded evaluation of clinical efficacy which showed a trend towards futility \& was not related to any safety concerns of vixarelimab.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
286 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05785624
Sponsor's protocol ID
GB44496
Other IDs
2022-502828-42, 2022-502828-42-00
Status last verified
Feb 2026
First submitted
14 Mar 2023
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vixarelimab in people with Idiopathic Pulmonary Fibrosis and Systemic Sclerosis With Lung Involvement, run by Genentech, Inc. at 114 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in United States, Argentina, Israel, Italy, Spain and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor decided to discontinue the study after review of clinical data by the iDMC. This decision was based on unblinded evaluation of clinical efficacy which showed a trend towards futility \& was not related to any safety concerns of vixarelimab.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohorts 1 and 2: Absolute Change From Baseline in Forced Vital Capacity (FVC) (time frame: Baseline up to Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05785624.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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