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 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.

Study Overview

• Status: Terminated
• Conditions: Idiopathic Pulmonary Fibrosis; Systemic Sclerosis With Lung Involvement
• Intervention / Treatment: Drug: Vixarelimab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 286
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426ABP
    • Centro Médico Dra de Salvo
  • Ciudad Autonoma Buenos Aires, Argentina, C1426ABP
    • Consultorios Médicos Dr. Doreski
  • Mar del Plata, Argentina, B7602DCK
    • Instituto Ave Pulmo
  • Mendoza, Argentina, 5500
    • Fundación Scherbovsky
  • Mendoza, Mendoza City, Argentina, M5500CCG
    • INSARES
  • Rosario, Argentina, S2013DTC
    • Instituto Médico de la Fundación Estudios Clínicos
  • Río Cuarto, Argentina, 5800
    • Instituto Médico Río Cuarto
  • San Miguel de Tucumán, Argentina, T4000AXL
    • Centro de Investigaciones Medicas Tucuman
  • San Miguel de Tucumán, Argentina, 4000
    • Instituto De Patologias Respiratorias
  • San Miguel de Tucumán, Argentina, T4000AXL
    • Centro de Investigaciones Reumatológicas
  • Santa Fe, Argentina, 3000
    • Instituto Del Buen Aire
• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital
    • Darlinghurst, New South Wales, Australia, 2010
      • St Vincent's Hospital Sydney
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Health Monash Medical Centre
• Belgium
  • Aalst, Belgium, 9300
    • AZORG Campus Aalst-Moorselbaan
  • Liège, Belgium, 4000
    • CHU de Liège
• Brazil
  • Federal District
    • Brasília, Federal District, Brazil, 70200-730
      • L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
    • Brasília, Federal District, Brazil, 71635580
      • Hospital Brasilia
  • Pará
    • Pôrto Alegre, Pará, Brazil, 90035-903
      • Hospital de Clinicas de Porto Alegre HCPA PPDS
  • Santa Catarina
    • Blumenau, Santa Catarina, Brazil, 89030-101
      • Hospital Dia do Pulmao
• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1W 1V3
      • Kelowna Allergy and Respiratory Health Clinic
  • Ontario
    • Ajax, Ontario, Canada, L1S 2J5
      • Dynamic Drug Advancement Ltd.
    • Windsor, Ontario, Canada, N8X 5A6
      • Dr Anil Dhar Professional Medicine Corporation
• Chile
  • Providencia, Chile, 7500587
    • Enroll SpA - PPDS
  • Talca, Chile, 3481349
    • Centro de Investigación del Maule
  • Ñuñoa, Chile, 7750495
    • CEC SpA
• France
  • Bobigny, France, 93000
    • Hopital Avicenne
  • Bron, France, 69677
    • Hôpital Louis Pradel
  • Marseille, France, 13015
    • Hopital Nord AP-HM
  • Montpellier, France, 34295
    • Hopital Arnaud de Villeneuve
  • Nice, France, 06001
    • Hopital Pasteur 2
  • Paris, France, 75018
    • Groupe Hospitalier Bichat Claude Bernard
  • Reims, France, 51100
    • CHU de Reims
• Germany
  • Berlin, Germany, 13125
    • Evangelische Lungenklinik Berlin
  • Düsseldorf, Germany, 40225
    • Universitaetsklinikum Duesseldorf
  • Essen, Germany, 45239
    • Ruhrlandklinik
• Greece
  • Heraklion, Greece, 711 10
    • University General Hospital of Heraklion
  • Larissa, Greece, 412 21
    • University General Hospital of Larissa
• Israel
  • Ashkelon, Israel, 7830604
    • Barzilai Medical Center
  • Beer Jacob, Israel, 0073100
    • Shamir Medical Center Assaf Harofeh
  • Haifa, Israel, 3109601
    • Rambam Medical Center
  • Haifa, Israel, 34362
    • Lady Davis Carmel Medical Center
  • Jerusalem, Israel, 9112001
    • Hadassah Medical Center
  • Petah Tikva, Israel, 52621
    • Rabin Medical Center
  • Ramat Gan, Israel, 5262100
    • The Chaim Sheba Medical Center
  • Rehovot, Israel, 7610001
    • Kaplan Medical Center
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Sourasky Medical Center PPDS
• Italy
  • Abruzzo
    • Siena, Abruzzo, Italy, 53100
      • Azienda Ospedaliera Universitaria Senese
  • Emilia-Romagna
    • Forlì, Emilia-Romagna, Italy, 47121
      • Presidio Ospedaliero GB Morgagni L Pierantoni
    • Reggio Emilia, Emilia-Romagna, Italy, 42100
      • Arcispedale Santa Maria Nuova
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario A Gemelli
  • Lombardy
    • Milan, Lombardy, Italy, 20123
      • Ospedale S. Giuseppe Multimedica
  • Piedmont
    • Turin, Piedmont, Italy, 10126
      • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Sicily
    • Catania, Sicily, Italy, 95123
      • Azienda Ospedaliera Universitaria "Policlinico - Vittorio Emanuele" (Presidio Gaspare Rodolico)
  • The Marches
    • Ancona, The Marches, Italy, 60020
      • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
  • Tuscany
    • Florence, Tuscany, Italy, 50134
      • Azienda Ospedaliera Universitaria Careggi
• Mexico
  • Jalisco
    • Americana, Jalisco, Mexico, 44160
      • cicum San Miguel
    • Guadalajara, Jalisco, Mexico, CP 44160
      • Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable - PPDS
  • Nuevo León
    • Monterrey, Nuevo León, Mexico
      • Hospital Universitario Dr. José Eleuterio González
• New Zealand
  • Christchurch, New Zealand, 8011
    • Christchurch Hospital
  • Dunedin, New Zealand
    • Dunedin Hospital
  • Hamilton, New Zealand, 3248
    • Waikato Hospital
• Poland
  • Lodz, Poland, 90-153
    • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
  • Rzeszów, Poland, 35-205
    • EMED Centrum Uslug Medycznych Ewa Smialek
  • Sosnowiec, Poland, 41-208
    • PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna
  • Warsaw, Poland, 04-141
    • Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
• South Africa
  • Cape Town, South Africa, 7130
    • Dr JM Engelbrecht Trial Site
  • Cape Town, South Africa, 7700
    • University of Cape Town Lung Institute UCTLI
  • Durban, South Africa, 4001
    • St Augustines Hospital
• South Korea
  • Incheon, South Korea, 21565
    • Gachon University Gil Medical Center
  • Seoul, South Korea, 05505
    • Asan Medical Center - PPDS
  • Seoul, South Korea, 06351
    • Samsung Medical Center - PPDS
  • Seoul, South Korea, 04763
    • Hanyang University Medical Center
  • Seoul, South Korea, 03312
    • The Catholic University of Korea Eunpyeong St. Mary's Hospital
• Spain
  • Barcelona, Spain, 8036
    • Hospital Clinic de Barcelona
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañón
  • Málaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria
  • Palma de Mallorca, Spain, 07120
    • Hospital Universitario Son Espases
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitario de Bellvitge
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marques de Valdecilla
  • LA Coruna
    • Santiago de Compostela, LA Coruna, Spain, 15706
      • CHUS H Clinico U de Santiago
  • Principality of Asturias
    • Oviedo, Principality of Asturias, Spain, 33011
      • Hospital Universitario Central de Asturias
• Taiwan
  • New Taipei City, Taiwan, 220
    • Far East Memorial Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85006-2506
      • Banner University Medicine Lung Institute
    • Tucson, Arizona, United States, 85723-0001
      • Southern Arizona VA Health Care System NAVREF PPDS
  • California
    • Fresno, California, United States, 93701-2302
      • University of California, San Francisco-Fresno
    • Los Angeles, California, United States, 90033-1036
      • University of Southern California Keck School of Medicine
    • Los Angeles, California, United States, 90095-8344
      • UCLA Rheumatology
    • San Francisco, California, United States, 94143-2204
      • University of California, San Francisco Medical Center
    • Torrance, California, United States, 90502
      • The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente
  • Florida
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research
    • St. Petersburg, Florida, United States, 33704-2733
      • Coastal Pulmonary and Critical Care PLC
    • Weston, Florida, United States, 33331-3609
      • Weston Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Clinic
    • Atlanta, Georgia, United States, 30309-1740
      • Piedmont Pulmonary and Sleep Medicine Buckhead
  • Illinois
    • Evergreen Park, Illinois, United States, 60805-2758
      • GenHarp Clinical Solutions
    • Glenview, Illinois, United States, 60026-8039
      • Northwestern Medicine - Northwestern Medicine Glen
  • Indiana
    • Muncie, Indiana, United States, 47303-3432
      • IU Health Ball Memorial Physicians Pulmonary and Critical Care Medicine
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Hospital
  • Missouri
    • Hannibal, Missouri, United States, 63401-6890
      • Hannibal Regional Healthcare System HRMG Hannibal
  • North Carolina
    • Greensboro, North Carolina, United States, 27403-4443
      • PulmonIx LLC
    • Winston-Salem, North Carolina, United States, 27103-4029
      • Southeastern Research Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104-5417
      • The University of Oklahoma Health Sciences Center
  • Texas
    • Dallas, Texas, United States, 75246-2073
      • Baylor Scott and White Health - Advanced Lung Disease Specialists - Dallas
    • Dallas, Texas, United States, 75254
      • IntraCare Health Center ? Prestige
    • El Paso, Texas, United States, 79902-1124
      • El Paso Pulmonary Association Elligo PPDS
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77030-1501
      • McGovern Medical School
  • Utah
    • Salt Lake City, Utah, United States, 84108-1287
      • University of UTAH - PPDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DBT: Cohort 2: Vixarelimab; Participants with SSC-ILD will receive vixarelimab, SC, Q2W for 52 weeks in the DBT period.	Drug: Vixarelimab; Vixarelimab will be administered as per the schedule specified in the respective arms.; Other Names: KPL-716; RO7622888
Placebo Comparator: DBT: Cohort 2: Placebo; Participants with SSC-ILD will receive vixarelimab matching placebo, SC, Q2W for 52 weeks in the DBT period.	Drug: Placebo; Placebo will be administered as per the schedule specified in the respective arms.
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.	Drug: Vixarelimab; Vixarelimab will be administered as per the schedule specified in the respective arms.; Other Names: KPL-716; RO7622888
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.	Drug: Vixarelimab; Vixarelimab will be administered as per the schedule specified in the respective arms.; Other Names: KPL-716; RO7622888
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. This cohort has completed enrollment and has been closed.	Drug: Vixarelimab; Vixarelimab will be administered as per the schedule specified in the respective arms.; Other Names: KPL-716; RO7622888
Placebo Comparator: DBT: Cohort 1: Placebo; 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; Placebo will be administered as per the schedule specified in the respective arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline up to Week 52
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.	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])	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.	Baseline up to Week 52
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.	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)
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.	Baseline up to Week 52
Cohorts 1 and 2: Percentage of Participants with Deaths		Up to Week 52
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.	Baseline up to Week 52
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.	Baseline up to Week 52
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.	Baseline up to Week 52
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.	Baseline up to Week 52
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.	Baseline up to Week 52
Cohorts 1, 2 and OLE Period: Number of Participants With Adverse Events (AEs)		Up to Week 52
Cohorts 1 and 2: Serum Concentration of Vixarelimab		Baseline up to Week 52
Cohorts 1 and 2: Number of Participants With Anti-Drug Antibodies (ADAs) to Vixarelimab		Baseline up to Week 52

Collaborators and Investigators

• Sponsor: Genentech, Inc.
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2023
• Primary Completion (Actual): January 12, 2026
• Study Completion (Actual): January 12, 2026

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Systemic Sclerosis-Associated Interstitial Lung Disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: GB44496; 2022-502828-42 (EudraCT Number); 2022-502828-42-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No