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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05785624




Registration number
NCT05785624
Ethics application status
Date submitted
14/03/2023
Date registered
27/03/2023

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
2022-502828-42
Secondary ID [2] 0 0
GB44496
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Systemic Sclerosis With Lung Involvement 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vixarelimab
Treatment: Drugs - Placebo

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.

Placebo comparator: DBT: Cohort 1: Placebo - Participants with IPF will receive vixarelimab matching placebo, SC, Q2W for 52 weeks in the DBT period.

Experimental: DBT: Cohort 2: Vixarelimab - Participants with SSC-ILD will receive vixarelimab, SC, Q2W for 52 weeks in the DBT period.

Placebo comparator: DBT: Cohort 2: Placebo - Participants with SSC-ILD will receive vixarelimab matching placebo, SC, Q2W for 52 weeks in the DBT period.

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.

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.


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

Treatment: Drugs: Placebo
Placebo will be administered as per the schedule specified in the respective arms.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cohorts 1 and 2: Absolute Change From Baseline in Forced Vital Capacity (FVC)
Timepoint [1] 0 0
Baseline up to Week 52
Secondary outcome [1] 0 0
Cohorts 1 and 2: Absolute Change From Baseline in 6-Minute Walk Test (6MWT) Distance
Timepoint [1] 0 0
Baseline up to Week 52
Secondary outcome [2] 0 0
Cohorts 1 and 2: Absolute Change From Baseline in Percentage of Predicted FVC
Timepoint [2] 0 0
Baseline up to Week 52
Secondary outcome [3] 0 0
Cohorts 1 and 2: Change From Baseline in Diffusion Capacity of the Lung for Carbon Monoxide Adjusted for Hemoglobin (DLco [Hb])
Timepoint [3] 0 0
Baseline up to Week 52
Secondary outcome [4] 0 0
Cohorts 1 and 2: Time to Disease Progression
Timepoint [4] 0 0
From the start of study treatment until disease progression or death, whichever occurs first (up to Week 52 of DBT)
Secondary outcome [5] 0 0
Cohorts 1 and 2: Time to First Acute Exacerbation of ILD, or Suspected Acute Exacerbation of ILD
Timepoint [5] 0 0
From the start of study treatment until end of DBT (up to Week 52)
Secondary outcome [6] 0 0
Cohorts 1 and 2: Change From Baseline in Quantitative Lung Fibrosis on High-Resolution Computed Tomography (HRCT) Scan of the Thorax
Timepoint [6] 0 0
Baseline up to Week 52
Secondary outcome [7] 0 0
Cohorts 1 and 2: Percentage of Participants with Deaths
Timepoint [7] 0 0
Up to Week 52
Secondary outcome [8] 0 0
Cohort 2: Change From Baseline in Skin Sclerosis Assessed Using Modified Rodnan Skin Score (mRSS)
Timepoint [8] 0 0
Baseline up to Week 52
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Baseline up to Week 52
Secondary outcome [10] 0 0
Cohorts 1 and 2: Change From Baseline in Cough Measured Using Living with Pulmonary Fibrosis (L-PF) Symptoms Cough Domain Score
Timepoint [10] 0 0
Baseline up to Week 52
Secondary outcome [11] 0 0
Cohorts 1 and 2: Change From Baseline in Dyspnea Measured Using L-PF Symptoms Dyspnea Domain Score
Timepoint [11] 0 0
Baseline up to Week 52
Secondary outcome [12] 0 0
Cohort 2: Change From Baseline in Pruritus Measured Using the Five-Dimension Itch Scale (5-D Itch) Total Score
Timepoint [12] 0 0
Baseline up to Week 52
Secondary outcome [13] 0 0
Cohorts 1, 2 and OLE Period: Number of Participants With Adverse Events (AEs)
Timepoint [13] 0 0
Up to Week 52
Secondary outcome [14] 0 0
Cohorts 1 and 2: Serum Concentration of Vixarelimab
Timepoint [14] 0 0
Baseline up to Week 52
Secondary outcome [15] 0 0
Cohorts 1 and 2: Number of Participants With Anti-Drug Antibodies (ADAs) to Vixarelimab
Timepoint [15] 0 0
Baseline up to Week 52

Eligibility
Key inclusion 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 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/08/2027
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [3] 0 0
Monash Health Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
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Georgia
Country [6] 0 0
United States of America
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Illinois
Country [7] 0 0
United States of America
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Indiana
Country [8] 0 0
United States of America
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Kansas
Country [9] 0 0
United States of America
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Michigan
Country [10] 0 0
United States of America
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Missouri
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United States of America
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North Carolina
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United States of America
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Oklahoma
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United States of America
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Texas
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United States of America
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Utah
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Cordoba
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Argentina
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Mar Del Plata
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Argentina
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Mendoza, Mendoza City
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Argentina
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Mendoza
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Argentina
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Rosario
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Argentina
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San Miguel de Tucuman
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Argentina
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Santa Fe
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Belgium
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Aalst
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Belgium
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Liège
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Roeselare
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DF
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Brazil
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PA
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SC
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British Columbia
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Ontario
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Nunoa
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Chile
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Providencia
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Chile
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Talca
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Reims
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Germany
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Essen
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Larissa
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Marche
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Italy
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Piemonte
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Italy
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Sicilia
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Italy
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Toscana
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Mexico
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Jalisco
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Mexico
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Nuevo LEON
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New Zealand
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Christchurch
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New Zealand
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Dunedin
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New Zealand
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Hamilton
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Poland
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Lodz
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Poland
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Rzeszów
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Poland
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Sosnowiec
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South Africa
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Cape Town
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South Africa
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City Of Cape Town
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South Africa
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Durban
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Spain
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Barcelona
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Spain
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Cantabria
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Spain
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Islas Baleares
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Spain
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LA Coruña
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Spain
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Madrid
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Spain
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Malaga
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Taiwan
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New Taipei
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Taiwan
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Taichung
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Taiwan
State/province [84] 0 0
Taipei City

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: GB44496 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Fax 0 0
Email 0 0
global-roche-genentech-trials@gene.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05785624