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| ID | Type | Description | Link |
|---|---|---|---|
| 2017 002667 17 | EudraCT Number |
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Sponsor decision
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The purpose of this study was to investigate the safety, tolerability and efficacy of VAY736 as potential therapy for the treatment of idiopathic pulmonary fibrosis (IPF).
This was an exploratory (non-confirmatory) randomized, patient-, investigator-, sponsor- blinded, placebo controlled study of VAY736 in IPF patients. This study investigated the safety and efficacy of 300 mg VAY736 administered subcutaneously (s.c.) every 4 weeks for 48 weeks.
Participants were randomized in a 1:1 ratio on top of local standard of care (SOC), to receive VAY736 or placebo. Randomized subjects entered the treatment epoch (for up to 48 weeks), followed by two follow-up epochs: the PK/safety follow-up epoch and the PD/safety follow-up epoch. The PK/safety follow-up epoch lasted for 20 weeks. When the PK/safety follow-up epoch was completed, participants in the placebo arm were discharged from the study; but participants in the active arm (those who had received VAY736) continued into the PD/safety follow-up epoch. Participants in the PD/safety follow-up epoch were followed until B-cell recovery (in the peripheral blood), defined as: B cells >=50/μL or B cells >= 80% of baseline (whichever occurred first). If a participant had not recovered his/her B-cells after a period of 2 years from the last dose of VAY736, then this participant was discharged from the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAY736 | Experimental | Participants received 300 mg VAY736 administered subcutaneously every 4 weeks for 48 weeks on top of current standard-of-care therapy |
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| Placebo | Placebo Comparator | Participants received placebo administered subcutaneously every 4 weeks for 48 weeks on top of current standard-of-care therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VAY736 | Drug | 300 mg VAY736 administered subcutaneously every 4 weeks for 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to End of Treatment Epoch (48 Weeks of Treatment) in Forced Vital Capacity (FVC). | FVC was defined as the maximum amount of air that an individual was able to forcibly exhale from his / her lungs after taking the deepest breath they could. Change from baseline to end of treatment epoch (48 weeks of treatment) in Forced Vital Capacity (FVC) was analyzed using a Mixed Effects Model for Repeated Measures (MMRM) and considering all assessments collected during the treatment epoch. The model included treatment and visit as fixed effects, standard of care treatment (Nintedanib, Pirfenidone, or no treatment) as factor and baseline value as a covariate, treatment-by-visit and baseline-by-visit as interaction terms. A positive change from baseline indicates improvement. Baseline was defined as the last available assessment pre-dose before or on randomization date. | From baseline up to 48 weeks post first dose of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With All-cause Mortality Events | All-cause mortality events were defined as deaths due to any cause. Kaplan-Meier estimates of the percentage of participants with the event of interest along with 80% two-sided confidence intervals using Greenwood's formula are provided. | Up to 48 weeks post first dose of study treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Birmingham | Alabama | 35294-0007 | United States | ||
| Novartis Investigative Site |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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A total of 142 participants were screened of which 30 participants were randomized. 1 participant in the VAY736 arm did not receive treatment as the patient withdrew consent before first dosing. Treatment epoch (duration of up to 48 weeks) was followed by: i) PK/safety follow-up epoch with duration of 20 weeks, and ii) PD/safety follow-up (only for participants who had received VAY736) until participants met pre-specified criteria for B-Cell recover or up to 2 years from the last dose of VAY736.
The study was conducted across 16 centers in 6 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | VAY736 | Participants received 300 mg VAY736 administered subcutaneously every 4 weeks for 48 weeks on top of current standard-of-care therapy |
| FG001 | Placebo | Participants received placebo administered subcutaneously every 4 weeks for 48 weeks on top of current standard-of-care therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Epoch |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 23, 2020 | Feb 13, 2023 |
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| Placebo | Drug | Placebo administered subcutaneously every 4 weeks for 48 weeks |
|
| Standard of Care (SoC) | Drug | Background standard-of-care treatment for IPF: nintedanib, pirfenidone, or no background therapy |
|
| Percentage of Participants With Survival Idiopathic Pulmonary Fibrosis (IPF) -Related Mortality Events | IPF-related mortality events were defined as deaths due to IPF related cause. Kaplan-Meier estimates of the percentage of participants with the event of interest along with 80% two-sided confidence intervals using Greenwood's formula are provided. | Up to 48 weeks post first dose of study treatment |
| Percentage of Participants With Progression-free Survival (PFS) Events | PFS events were divided into: 1) PFS1 events including progression (relative reduction in FVC ≥ 10%) or death due to all causes, and 2) PFS2 events including progression (relative reduction in FVC ≥ 10%) or death due to IPF-related causes. Kaplan-Meier estimates of the percentage of participants with the event of interest (PFS1 events or PFS2 events) along with 80% two-sided confidence intervals using Greenwood's formula are provided. | Up to 48 weeks post first dose of study treatment |
| Percentage of Participants With Disease Progression Events | The following disease progression events were considered: a) relative reduction in FVC ≥ 10%; b) relative reduction in Diffusing Capacity of the Lungs (DLCO) ≥ 15%; c) absolute reduction in Six Minute Walk Distance (6MWD) ≥ 50 m. Kaplan-Meier estimates of the percentage of participants with the event of interest along with 80% two-sided confidence intervals using Greenwood's formula are provided. | Up to 48 weeks post first dose of study treatment |
| Percentage of Participants With Composite Events | Composite events were defined as: 1) death (all-cause mortality), or relative reduction in FVC ≥ 10%, or relative reduction in DLCO ≥ 15%, or relative reduction in 6MWD ≥ 50 m (composite endpoint 1); and 2) Death (IPF-related mortality), or relative reduction in FVC ≥ 10%, or relative reduction in DLCO ≥ 15%, or relative reduction in 6MWD ≥ 50 m (composite endpoint 2). Kaplan-Meier estimates of the percentage of participants with the event of interest along with 80% two-sided confidence intervals using Greenwood's formula are provided. | Up to 48 weeks post first dose of study treatment |
| Change From Baseline to End of Treatment Epoch (48 Weeks of Treatment) in Diffusing Capacity of the Lungs | DLCO is a measurement to assess the lungs' ability to transfer gas from inspired air to the bloodstream. DLCO was determined according to ATS guidelines. Change from baseline to end of treatment epoch (48 weeks of treatment) in diffusing capacity of the lung for carbon monoxide (DLCO) was analyzed using a Mixed Effects Model for Repeated Measures (MMRM) and considering all assessments collected during the treatment epoch. The model included treatment and visit as fixed effects, standard of care treatment (Nintedanib, Pirfenidone, or no treatment) as factor and baseline value as a covariate, treatment-by-visit and baseline-by-visit as interaction terms. A positive change from baseline indicates improvement. Baseline was defined as the last available assessment pre-dose before or on randomization date. | From baseline up to 48 weeks post first dose of study treatment |
| Change From Baseline to the End of Treatment Epoch (48 Weeks of Treatment) in 6-minute Walk Distance (6MWD) | A standardized 6-minute walk test (6MWT) was performed in accordance with the guidelines of the American Thoracic Society 2002. The distance walked in six minutes (6MWD) was recorded. Change from baseline to end of treatment epoch (48 weeks of treatment) in 6MWD was analyzed using a Mixed Effects Model for Repeated Measures (MMRM) and considering all assessments collected during the treatment epoch. The model included treatment and visit as fixed effects, standard of care treatment (Nintedanib, Pirfenidone, or no treatment) as factor and baseline value as a covariate, treatment-by-visit and baseline-by-visit as interaction terms. A positive change from baseline indicates improvement. Baseline was defined as the last available assessment pre-dose before or on randomization date. | From baseline up to 48 weeks post first dose of study treatment |
| Change From Baseline to the End of Treatment Epoch (48 Weeks of Treatment) in Distance Saturation Product | Distance saturation product is the product of distance walked and lowest oxygen saturation during the 6-min walk test. Change from baseline to end of treatment epoch (48 weeks of treatment) in distance saturation product was analyzed using a Mixed Effects Model for Repeated Measures (MMRM) and considering all assessments collected during the treatment epoch. The model included treatment and visit as fixed effects, standard of care treatment (Nintedanib, Pirfenidone, or no treatment) as factor and baseline value as a covariate, treatment-by-visit and baseline-by-visit as interaction terms. A positive change from baseline indicates improvement. Baseline was defined as the last available assessment pre-dose before or on randomization date. | From baseline up to 48 weeks post first dose of study treatment |
| Change From Baseline to the End of Treatment Epoch (48 Weeks of Treatment) in Resting Oxygen Saturation Level (on Room Air) | Change from baseline to end of treatment epoch (48 weeks of treatment) in resting oxygen saturation (on room air) was analyzed using a Mixed Effects Model for Repeated Measures (MMRM) and considering all assessments collected during the treatment epoch. The model included treatment and visit as fixed effects, standard of care treatment (Nintedanib, Pirfenidone, or no treatment) as factor and baseline value as a covariate, treatment-by-visit and baseline-by-visit as interaction terms. A positive change from baseline indicates improvement. Baseline was defined as the last available assessment pre-dose before or on randomization date. | From baseline up to 48 weeks post first dose of study treatment |
| Number of Participants With Positive Serum Anti-VAY736 Antibodies | Number of participants with positive serum anti-VAY736 antibodies. A bridging ELISA method that is designed to detect the presence of anti-VAY736 antibodies in human serum was used. | Day 1, 29, 85, 169, 253 and 337 |
| Ctrough of VAY736 From the Serum Concentration-time Data | The lowest serum concentration of VAY736 observed during a dosing interval at steady state (Ctrough) was determined | At pre-dose on Day 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309 and 337 |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Novartis Investigative Site | Miami | Florida | 33136 | United States |
| Novartis Investigative Site | Durham | North Carolina | 27710 | United States |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Novartis Investigative Site | Nashville | Tennessee | 37203 | United States |
| Novartis Investigative Site | Salt Lake City | Utah | 84108 | United States |
| Novartis Investigative Site | Calgary | Alberta | T2N 2T9 | Canada |
| Novartis Investigative Site | Coswig | 01640 | Germany |
| Novartis Investigative Site | Hanover | 30625 | Germany |
| Novartis Investigative Site | Dublin | D04 | Ireland |
| Novartis Investigative Site | Forlì | FC | 47100 | Italy |
| Novartis Investigative Site | Modena | MO | 41124 | Italy |
| Novartis Investigative Site | Siena | SI | 53100 | Italy |
| Novartis Investigative Site | Cambridge | Cambridgeshire | CB23 3RE | United Kingdom |
| Novartis Investigative Site | High Heaton | Newcastle Upon Tyne | NE7 7DN | United Kingdom |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| PK/Safety Follow-up Epoch |
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| PD/Safety Follow-up Epoch |
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Baseline characteristics are provided for all participants who received at least one dose of any study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | VAY736 | Participants received 300 mg VAY736 administered subcutaneously every 4 weeks for 48 weeks on top of current standard-of-care therapy |
| BG001 | Placebo | Participants received placebo administered subcutaneously every 4 weeks for 48 weeks on top of current standard-of-care therapy |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to End of Treatment Epoch (48 Weeks of Treatment) in Forced Vital Capacity (FVC). | FVC was defined as the maximum amount of air that an individual was able to forcibly exhale from his / her lungs after taking the deepest breath they could. Change from baseline to end of treatment epoch (48 weeks of treatment) in Forced Vital Capacity (FVC) was analyzed using a Mixed Effects Model for Repeated Measures (MMRM) and considering all assessments collected during the treatment epoch. The model included treatment and visit as fixed effects, standard of care treatment (Nintedanib, Pirfenidone, or no treatment) as factor and baseline value as a covariate, treatment-by-visit and baseline-by-visit as interaction terms. A positive change from baseline indicates improvement. Baseline was defined as the last available assessment pre-dose before or on randomization date. | Pharmacodynamic (PD) analysis set including participants with available PD data and no protocol deviations with relevant impact on PD data. Only participants with a value at both Baseline and end of treatment (48 weeks post-first dose of treatment) were included in the analysis. | Posted | Least Squares Mean | Standard Error | Liter (L) | From baseline up to 48 weeks post first dose of study treatment |
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| Secondary | Percentage of Participants With All-cause Mortality Events | All-cause mortality events were defined as deaths due to any cause. Kaplan-Meier estimates of the percentage of participants with the event of interest along with 80% two-sided confidence intervals using Greenwood's formula are provided. | PD analysis set including participants with available PD data and no protocol deviations with relevant impact on PD data. | Posted | Number | 80% Confidence Interval | Percentage of participants | Up to 48 weeks post first dose of study treatment |
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| Secondary | Percentage of Participants With Survival Idiopathic Pulmonary Fibrosis (IPF) -Related Mortality Events | IPF-related mortality events were defined as deaths due to IPF related cause. Kaplan-Meier estimates of the percentage of participants with the event of interest along with 80% two-sided confidence intervals using Greenwood's formula are provided. | PD analysis set including participants with available PD data and no protocol deviations with relevant impact on PD data. | Posted | Number | 80% Confidence Interval | Percentage of participants | Up to 48 weeks post first dose of study treatment |
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| Secondary | Percentage of Participants With Progression-free Survival (PFS) Events | PFS events were divided into: 1) PFS1 events including progression (relative reduction in FVC ≥ 10%) or death due to all causes, and 2) PFS2 events including progression (relative reduction in FVC ≥ 10%) or death due to IPF-related causes. Kaplan-Meier estimates of the percentage of participants with the event of interest (PFS1 events or PFS2 events) along with 80% two-sided confidence intervals using Greenwood's formula are provided. | PD analysis set including participants with available PD data and no protocol deviations with relevant impact on PD data. | Posted | Number | 80% Confidence Interval | Percentage of participants | Up to 48 weeks post first dose of study treatment |
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| Secondary | Percentage of Participants With Disease Progression Events | The following disease progression events were considered: a) relative reduction in FVC ≥ 10%; b) relative reduction in Diffusing Capacity of the Lungs (DLCO) ≥ 15%; c) absolute reduction in Six Minute Walk Distance (6MWD) ≥ 50 m. Kaplan-Meier estimates of the percentage of participants with the event of interest along with 80% two-sided confidence intervals using Greenwood's formula are provided. | PD analysis set including participants with available PD data and no protocol deviations with relevant impact on PD data. | Posted | Number | 80% Confidence Interval | Percentage of participants | Up to 48 weeks post first dose of study treatment |
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| Secondary | Percentage of Participants With Composite Events | Composite events were defined as: 1) death (all-cause mortality), or relative reduction in FVC ≥ 10%, or relative reduction in DLCO ≥ 15%, or relative reduction in 6MWD ≥ 50 m (composite endpoint 1); and 2) Death (IPF-related mortality), or relative reduction in FVC ≥ 10%, or relative reduction in DLCO ≥ 15%, or relative reduction in 6MWD ≥ 50 m (composite endpoint 2). Kaplan-Meier estimates of the percentage of participants with the event of interest along with 80% two-sided confidence intervals using Greenwood's formula are provided. | PD analysis set including participants with available PD data and no protocol deviations with relevant impact on PD data. | Posted | Number | 80% Confidence Interval | Percentage of participants | Up to 48 weeks post first dose of study treatment |
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| Secondary | Change From Baseline to End of Treatment Epoch (48 Weeks of Treatment) in Diffusing Capacity of the Lungs | DLCO is a measurement to assess the lungs' ability to transfer gas from inspired air to the bloodstream. DLCO was determined according to ATS guidelines. Change from baseline to end of treatment epoch (48 weeks of treatment) in diffusing capacity of the lung for carbon monoxide (DLCO) was analyzed using a Mixed Effects Model for Repeated Measures (MMRM) and considering all assessments collected during the treatment epoch. The model included treatment and visit as fixed effects, standard of care treatment (Nintedanib, Pirfenidone, or no treatment) as factor and baseline value as a covariate, treatment-by-visit and baseline-by-visit as interaction terms. A positive change from baseline indicates improvement. Baseline was defined as the last available assessment pre-dose before or on randomization date. | Pharmacodynamic (PD) analysis set including participants with available PD data and no protocol deviations with relevant impact on PD data. Only participants with a value at both Baseline and end of treatment (48 weeks post-first dose of treatment) were included in the analysis. | Posted | Least Squares Mean | Standard Error | mililiter/minute/millimeter Mercury | From baseline up to 48 weeks post first dose of study treatment |
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| Secondary | Change From Baseline to the End of Treatment Epoch (48 Weeks of Treatment) in 6-minute Walk Distance (6MWD) | A standardized 6-minute walk test (6MWT) was performed in accordance with the guidelines of the American Thoracic Society 2002. The distance walked in six minutes (6MWD) was recorded. Change from baseline to end of treatment epoch (48 weeks of treatment) in 6MWD was analyzed using a Mixed Effects Model for Repeated Measures (MMRM) and considering all assessments collected during the treatment epoch. The model included treatment and visit as fixed effects, standard of care treatment (Nintedanib, Pirfenidone, or no treatment) as factor and baseline value as a covariate, treatment-by-visit and baseline-by-visit as interaction terms. A positive change from baseline indicates improvement. Baseline was defined as the last available assessment pre-dose before or on randomization date. | Pharmacodynamic (PD) analysis set including participants with available PD data and no protocol deviations with relevant impact on PD data. Only participants with a value at both Baseline and end of treatment (48 weeks post-first dose of treatment) were included in the analysis. | Posted | Least Squares Mean | Standard Error | Meter (m) | From baseline up to 48 weeks post first dose of study treatment |
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| Secondary | Change From Baseline to the End of Treatment Epoch (48 Weeks of Treatment) in Distance Saturation Product | Distance saturation product is the product of distance walked and lowest oxygen saturation during the 6-min walk test. Change from baseline to end of treatment epoch (48 weeks of treatment) in distance saturation product was analyzed using a Mixed Effects Model for Repeated Measures (MMRM) and considering all assessments collected during the treatment epoch. The model included treatment and visit as fixed effects, standard of care treatment (Nintedanib, Pirfenidone, or no treatment) as factor and baseline value as a covariate, treatment-by-visit and baseline-by-visit as interaction terms. A positive change from baseline indicates improvement. Baseline was defined as the last available assessment pre-dose before or on randomization date. | Pharmacodynamic (PD) analysis set including participants with available PD data and no protocol deviations with relevant impact on PD data. Only participants with a value at both Baseline and end of treatment (48 weeks post-first dose of treatment) were included in the analysis. | Posted | Least Squares Mean | Standard Error | Meter% (m%) | From baseline up to 48 weeks post first dose of study treatment |
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| Secondary | Change From Baseline to the End of Treatment Epoch (48 Weeks of Treatment) in Resting Oxygen Saturation Level (on Room Air) | Change from baseline to end of treatment epoch (48 weeks of treatment) in resting oxygen saturation (on room air) was analyzed using a Mixed Effects Model for Repeated Measures (MMRM) and considering all assessments collected during the treatment epoch. The model included treatment and visit as fixed effects, standard of care treatment (Nintedanib, Pirfenidone, or no treatment) as factor and baseline value as a covariate, treatment-by-visit and baseline-by-visit as interaction terms. A positive change from baseline indicates improvement. Baseline was defined as the last available assessment pre-dose before or on randomization date. | Pharmacodynamic (PD) analysis set including participants with available PD data and no protocol deviations with relevant impact on PD data. Only participants with a value at both Baseline and end of treatment (48 weeks post-first dose of treatment) were included in the analysis. | Posted | Least Squares Mean | Standard Error | Percentage (%) | From baseline up to 48 weeks post first dose of study treatment |
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| Secondary | Number of Participants With Positive Serum Anti-VAY736 Antibodies | Number of participants with positive serum anti-VAY736 antibodies. A bridging ELISA method that is designed to detect the presence of anti-VAY736 antibodies in human serum was used. | Immunogenicity (IG) analysis set including all participants with at least one available valid (i.e. not flagged for exclusion) IG concentration measurement, who received any study drug and with no protocol deviations that impact on IG data. | Posted | Number | Participants | Day 1, 29, 85, 169, 253 and 337 |
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| Secondary | Ctrough of VAY736 From the Serum Concentration-time Data | The lowest serum concentration of VAY736 observed during a dosing interval at steady state (Ctrough) was determined | Overall number of participants analyzed represents the Pharmacokinetic (PK) analysis set including all participants with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement who received at least one dose of VAY736 and with no protocol deviations that impact on PK data. The number of participants analyzed in each row represents the number of participants with a valid value in the corresponding time point. | Posted | Mean | Standard Deviation | nanogram (ng) / mililiter (mL) | At pre-dose on Day 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309 and 337 |
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From baseline up to end of study, assessed up to approximately 2.4 years
Safety analyses were performed in the safety set including all participants who received at least one dose of any study drug
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VAY736 | Participants received 300 mg VAY736 administered subcutaneously every 4 weeks for 48 weeks on top of current standard-of-care therapy | 1 | 13 | 5 | 13 | 13 | 13 |
| EG001 | Placebo | Participants received placebo administered subcutaneously every 4 weeks for 48 weeks on top of current standard-of-care therapy | 0 | 16 | 9 | 16 | 15 | 16 |
| EG002 | Total | Total | 1 | 29 | 14 | 29 | 28 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aortic valve incompetence | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Retinal vein occlusion | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
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| Eustachian tube dysfunction | Ear and labyrinth disorders | MedDRA (25.0) | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA (25.0) | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Corneal degeneration | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Injection site dermatitis | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Injection site inflammation | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Heat stroke | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Injection related reaction | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Antinuclear antibody increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Blood parathyroid hormone decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Escherichia test positive | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Glucose urine present | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Mean cell volume increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Monocyte count increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Urine albumin/creatinine ratio increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Urine analysis abnormal | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Urine protein/creatinine ratio increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Dysplastic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Keratoacanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cervical radiculopathy | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Keloid scar | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 6, 2020 | Feb 13, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000656267 | ianalumab |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
| Male |
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| Participants |
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Participants received placebo administered subcutaneously every 4 weeks for 48 weeks on top of current standard-of-care therapy |
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Participants received placebo administered subcutaneously every 4 weeks for 48 weeks on top of current standard-of-care therapy
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