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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

Primary Purpose

Idiopathic Pulmonary Fibrosis, Systemic Sclerosis With Lung Involvement

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vixarelimab
Placebo
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Systemic Sclerosis-Associated Interstitial Lung Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • Renstar Medical ResearchRecruiting
  • Central Florida Pulmonary Group, PARecruiting
  • Coastal Pulmonary and Critical Care PLCRecruiting
  • Hannibal Regional Healthcare System HRMG HannibalRecruiting
  • Pulmonix LLCRecruiting
  • Southeastern Research CenterRecruiting
  • El Paso Pulmonary Association Elligo PPDSRecruiting
  • Onze Lieve Vrouwziekenhuis AalstRecruiting
  • CEC SpARecruiting
  • Enroll SpA - PPDSRecruiting
  • Hopital Louis PradelRecruiting
  • Hopital Pasteur 2Recruiting
  • Groupe Hospitalier Bichat Claude BernardRecruiting
  • University General Hospital of HeraklionRecruiting
  • Shamir Medical Center Assaf HarofehRecruiting
  • Rabin Medical CenterRecruiting
  • Presidio Ospedaliero GB Morgagni L PierantoniRecruiting
  • CHUS H Clinico U de SantiagoRecruiting
  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

DBT: Cohort 1: Vixarelimab

DBT: Cohort 1: Placebo

DBT: Cohort 2: Vixarelimab

DBT: Cohort 2: Placebo

OLE Period: Cohort 1: Vixarelimab

OLE Period: Cohort 2: Vixarelimab

Arm Description

Participants with IPF will receive vixarelimab, subcutaneously (SC), once every two weeks (Q2W) for 52 weeks in the DBT period.

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

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

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

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Cohorts 1 and 2: Time to First Acute Exacerbation of ILD, or Suspected Acute Exacerbation of ILD
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.
Cohorts 1 and 2: Percentage of Participants with Deaths
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.
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.
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.
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.
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.
Cohorts 1, 2 and OLE Period: Number of Participants With Adverse Events (AEs)
Cohorts 1 and 2: Serum Concentration of Vixarelimab
Cohorts 1 and 2: Number of Participants With Anti-Drug Antibodies (ADAs) to Vixarelimab

Full Information

First Posted
March 14, 2023
Last Updated
October 20, 2023
Sponsor
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05785624
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2023 (Actual)
Primary Completion Date
April 26, 2027 (Anticipated)
Study Completion Date
August 10, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis, Systemic Sclerosis With Lung Involvement
Keywords
Systemic Sclerosis-Associated Interstitial Lung Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
290 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DBT: Cohort 1: Vixarelimab
Arm Type
Experimental
Arm Description
Participants with IPF will receive vixarelimab, subcutaneously (SC), once every two weeks (Q2W) for 52 weeks in the DBT period.
Arm Title
DBT: Cohort 1: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants with IPF will receive vixarelimab matching placebo, SC, Q2W for 52 weeks in the DBT period.
Arm Title
DBT: Cohort 2: Vixarelimab
Arm Type
Experimental
Arm Description
Participants with SSC-ILD will receive vixarelimab, SC, Q2W for 52 weeks in the DBT period.
Arm Title
DBT: Cohort 2: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants with SSC-ILD will receive vixarelimab matching placebo, SC, Q2W for 52 weeks in the DBT period.
Arm Title
OLE Period: Cohort 1: Vixarelimab
Arm Type
Experimental
Arm Description
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.
Arm Title
OLE Period: Cohort 2: Vixarelimab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vixarelimab
Other Intervention Name(s)
RO7622888, KPL-716
Intervention Description
Vixarelimab will be administered as per the schedule specified in the respective arms.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered as per the schedule specified in the respective arms.
Primary Outcome Measure Information:
Title
Cohorts 1 and 2: Absolute Change From Baseline in Forced Vital Capacity (FVC)
Description
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.
Time Frame
Baseline up to Week 52
Secondary Outcome Measure Information:
Title
Cohorts 1 and 2: Absolute Change From Baseline in 6-Minute Walk Test (6MWT) Distance
Description
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.
Time Frame
Baseline up to Week 52
Title
Cohorts 1 and 2: Absolute Change From Baseline in Percentage of Predicted FVC
Description
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.
Time Frame
Baseline up to Week 52
Title
Cohorts 1 and 2: Change From Baseline in Diffusion Capacity of the Lung for Carbon Monoxide Adjusted for Hemoglobin (DLco [Hb])
Description
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.
Time Frame
Baseline up to Week 52
Title
Cohorts 1 and 2: Time to Disease Progression
Description
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.
Time Frame
From the start of study treatment until disease progression or death, whichever occurs first (up to Week 52 of DBT)
Title
Cohorts 1 and 2: Time to First Acute Exacerbation of ILD, or Suspected Acute Exacerbation of ILD
Time Frame
From the start of study treatment until end of DBT (up to Week 52)
Title
Cohorts 1 and 2: Change From Baseline in Quantitative Lung Fibrosis on High-Resolution Computed Tomography (HRCT) Scan of the Thorax
Description
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.
Time Frame
Baseline up to Week 52
Title
Cohorts 1 and 2: Percentage of Participants with Deaths
Time Frame
Up to Week 52
Title
Cohort 2: Change From Baseline in Skin Sclerosis Assessed Using Modified Rodnan Skin Score (mRSS)
Description
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.
Time Frame
Baseline up to Week 52
Title
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
Description
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.
Time Frame
Baseline up to Week 52
Title
Cohorts 1 and 2: Change From Baseline in Cough Measured Using Living with Pulmonary Fibrosis (L-PF) Symptoms Cough Domain Score
Description
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.
Time Frame
Baseline up to Week 52
Title
Cohorts 1 and 2: Change From Baseline in Dyspnea Measured Using L-PF Symptoms Dyspnea Domain Score
Description
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.
Time Frame
Baseline up to Week 52
Title
Cohort 2: Change From Baseline in Pruritus Measured Using the Five-Dimension Itch Scale (5-D Itch) Total Score
Description
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.
Time Frame
Baseline up to Week 52
Title
Cohorts 1, 2 and OLE Period: Number of Participants With Adverse Events (AEs)
Time Frame
Up to Week 52
Title
Cohorts 1 and 2: Serum Concentration of Vixarelimab
Time Frame
Baseline up to Week 52
Title
Cohorts 1 and 2: Number of Participants With Anti-Drug Antibodies (ADAs) to Vixarelimab
Time Frame
Baseline up to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: GB44496 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. Only)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Individual Site Status
Recruiting
Facility Name
Central Florida Pulmonary Group, PA
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Name
Coastal Pulmonary and Critical Care PLC
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33704-2733
Country
United States
Individual Site Status
Recruiting
Facility Name
Hannibal Regional Healthcare System HRMG Hannibal
City
Hannibal
State/Province
Missouri
ZIP/Postal Code
63401-6890
Country
United States
Individual Site Status
Recruiting
Facility Name
Pulmonix LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Individual Site Status
Recruiting
Facility Name
Southeastern Research Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103-4029
Country
United States
Individual Site Status
Recruiting
Facility Name
El Paso Pulmonary Association Elligo PPDS
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902-1124
Country
United States
Individual Site Status
Recruiting
Facility Name
Onze Lieve Vrouwziekenhuis Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CEC SpA
City
Nunoa
ZIP/Postal Code
7750000
Country
Chile
Individual Site Status
Recruiting
Facility Name
Enroll SpA - PPDS
City
Providencia
ZIP/Postal Code
7500587
Country
Chile
Individual Site Status
Recruiting
Facility Name
Hopital Louis Pradel
City
Bron
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Pasteur 2
City
Nice Cedex 1
ZIP/Postal Code
06001
Country
France
Individual Site Status
Recruiting
Facility Name
Groupe Hospitalier Bichat Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Name
University General Hospital of Heraklion
City
Heraklio
ZIP/Postal Code
711 10
Country
Greece
Individual Site Status
Recruiting
Facility Name
Shamir Medical Center Assaf Harofeh
City
Beer Jacob
ZIP/Postal Code
0073100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Name
Presidio Ospedaliero GB Morgagni L Pierantoni
City
Forli'
State/Province
Emilia-Romagna
ZIP/Postal Code
47121
Country
Italy
Individual Site Status
Recruiting
Facility Name
CHUS H Clinico U de Santiago
City
Santiago de Compostela
State/Province
LA Coruña
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

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

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