| Primary | Number of Participants Discontinuing Study Treatment Due to TEAEs | The number of participants with TEAEs leading to discontinuation from the study treatment. The Safety Population (including all participants who received at least one dose of study treatment) is presented. TEAE = treatment-emergent adverse event | Safety Population (includes all participants who received at least one dose of study treatment) | Posted | | Count of Participants | | Participants | | Change in the incidence and severity of adverse events related to study treatment from baseline to 24 weeks | | | | ID | Title | Description |
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| OG000 | Placebo | Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG001 | ND-L02-s0201 45 mg | ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG002 | ND-L02-s0201 90 mg | ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. |
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| Secondary | Rate of Decline in FVC From Baseline to Week 24 | Slope in FVC from Baseline to Week 24 (measured in L/week). The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented. Slope and standard error are presented. The slope is approximated as least square mean/24 weeks. FVC = forced vital capacity | ITT Population (include any randomized participants with treatment assignment according to the planned randomization) | Posted | | Mean | Standard Error | litres/week | | Baseline to Week 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG001 | ND-L02-s0201 45 mg | ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG002 | ND-L02-s0201 90 mg | ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. |
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| Secondary | Rate of Decline in ppFVC From Baseline to Week 24 | Slope in ppFVC from Baseline to Week 24 (measured in %/week). The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented. Slope and standard error are presented. The slope is approximated as least square mean/24 weeks. ppFVC = percent predicted forced vital capacity | ITT Population (include any randomized participants with treatment assignment according to the planned randomization) | Posted | | Mean | Standard Error | %/week | | Baseline to Week 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG001 | ND-L02-s0201 45 mg | ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG002 | ND-L02-s0201 90 mg | ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. |
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| Secondary | Absolute and Relative Change in FVC (L) From Baseline to Week 24 | Absolute and Relative Change in FVC (L) from Baseline to Week 24. The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented. FVC = forced vital capacity | | Posted | | Least Squares Mean | Standard Error | litres | | Baseline to Week 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG001 | ND-L02-s0201 45 mg | ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG002 | ND-L02-s0201 90 mg | ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. |
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| Secondary | Percent Change in FVC From Baseline to Week 24 | Percent Change in FVC from Baseline to Week 24. The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented. FVC = forced vital capacity | ITT Population (include any randomized participants with treatment assignment according to the planned randomization) | Posted | | Least Squares Mean | Standard Error | percentage | | Baseline to Week 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG001 | ND-L02-s0201 45 mg | ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG002 | ND-L02-s0201 90 mg | ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. |
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| Secondary | Absolute and Relative Change in ppFVC (%) From Baseline to Week 24 | Absolute and Relative Change in ppFVC (%) from Baseline to Week 24. The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented. ppFVC = percent predicted forced vital capacity | ITT Population (include any randomized participants with treatment assignment according to the planned randomization) | Posted | | Least Squares Mean | Standard Error | percent | | Baseline to Week 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG001 | ND-L02-s0201 45 mg | ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG002 | ND-L02-s0201 90 mg | ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. |
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| Secondary | Percent Change in ppFVC From Baseline to Week 24 | Percent Change in ppFVC from Baseline to Week 24. The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented. ppFVC = percent predicted forced vital capacity | ITT Population (include any randomized participants with treatment assignment according to the planned randomization) | Posted | | Least Squares Mean | Standard Error | percentage | | Baseline to Week 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG001 | ND-L02-s0201 45 mg | ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG002 | ND-L02-s0201 90 mg | ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. |
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| Secondary | Summary of Study Treatment Response of FVC | Proportion of participants with an FVC response defined as either having improvement or a decline by 0 to less than or equal to 5%, more than 5% to less than or equal to 10%, and more than 10% at Visit 14 (Day 169). Participants with an FVC response were defined as improvement in FVC (ie, FVC value higher than baseline) or a decline of less than or equal to 10% from baseline. The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented. FVC = forced vital capacity | ITT Population (include any randomized participants with treatment assignment according to the planned randomization) with FVC assessment at Visit 14 | Posted | | Count of Participants | | Participants | | Baseline to Visit 14 (Day 169) | | | | ID | Title | Description |
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| OG000 | Placebo | Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG001 | ND-L02-s0201 45 mg | ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG002 | ND-L02-s0201 90 mg |
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| Secondary | Summary of Study Treatment Response of ppFVC | Proportion of participants with an ppFVC response defined as either having improvement or a decline by 0 to less than or equal to 5%, greater than 5% to less than or equal to 10%, and greater than 10% at Visit 14 (Day 169). Participants with an ppFVC response were defined as improvement in ppFVC (ie, ppFVC value higher than baseline) or a decline of less than or equal to 10% from baseline. The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented. ppFVC = percent predicted forced vital capacity | ITT Population (include any randomized participants with treatment assignment according to the planned randomization) with ppFVC assessment at Visit 14 | Posted | | Count of Participants | | Participants | | Baseline to Visit 14 (Day 169) | | | | ID | Title | Description |
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| OG000 | Placebo | Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG001 | ND-L02-s0201 45 mg | ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG002 | ND-L02-s0201 90 mg |
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| Secondary | Change in DLCO and DLCO Corrected for Hemoglobin From Baseline to Week 24 | Change in diffusion capacity of the lung for carbon monoxide (DLCO) and DLCO corrected for hemoglobin (mL/min/mmHg) from Baseline to Week 24. The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented. | ITT Population (include any randomized participants with treatment assignment according to the planned randomization) | Posted | | Least Squares Mean | Standard Error | mL/min/mmHg | | Baseline to Week 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG001 | ND-L02-s0201 45 mg | ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG002 | ND-L02-s0201 90 mg | ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. |
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| Secondary | Quantitative Changes of Interstitial Lung Abnormalities as Measured by HRCT | Changes of interstitial lung abnormalities as measured by high-resolution computed tomography (HRCT; ie, change in parenchymal feature [Baseline to Week 24]), as determined by qualitative assessment (central radiologist) and quantitative analysis (Quantitative Lung Fibrosis - QLF analysis). Quantitative HRCT parameters included the following:
- Quantitative Lung Fibrosis (QLF) score (% of whole lung field volume)
- Ground glass opacity (GGO) (% of whole lung field volume)
- Reticulation (% of whole lung field volume)
- Honeycombing (% of whole lung field volume)
- Normal lung (% of whole lung field volume)
- Emphysema (low attenuation area [LAA]; % of whole lung field volume)
The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented. | ITT Population (include any randomized participants with treatment assignment according to the planned randomization) | Posted | | Least Squares Mean | Standard Error | percentage | | Baseline to Week 24 | | | | ID | Title | Description |
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| OG000 | Placebo | Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG001 | ND-L02-s0201 45 mg | ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. |
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| Secondary | Qualitative Changes of Interstitial Lung Abnormalities as Measured by HRCT | Changes of interstitial lung abnormalities as measured by high-resolution computed tomography (HRCT; ie, change in parenchymal feature [Baseline to Visit 14 (Day 169)]), as determined by qualitative assessment (central radiologist). The Likert scale values are included in the descriptions presented. The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) with HRCT assessment at Visit 14/Early Termination is presented. | ITT Population (include any randomized participants with treatment assignment according to the planned randomization) with HRCT assessment at Visit 14/Early Termination | Posted | | Count of Participants | | Participants | | Baseline to Visit 14 (Day 169) | | | | ID | Title | Description |
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| OG000 | Placebo | Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG001 | ND-L02-s0201 45 mg | ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG002 | ND-L02-s0201 90 mg |
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| Secondary | Events of IPF Exacerbation or Death and Rate of First IPF Exacerbation | Total number of events of participants who experienced idiopathic pulmonary fibrosis (IPF) exacerbation (ie, an unexplained worsening of dyspnea, evidence of hypoxemia as defined by worsened or severely impaired gas exchange, new radiographic alveolar infiltrates, and an absence of an alternative explanation such as infection, pulmonary embolism, pneumothorax, or heart failure) or death (weeks). | ITT Population (include any randomized participants with treatment assignment according to the planned randomization) | Posted | | Number | | events | | Baseline to study completion, up to Day 239 | | | | ID | Title | Description |
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| OG000 | Placebo | Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG001 | ND-L02-s0201 45 mg | ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG002 | ND-L02-s0201 90 mg | ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. |
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| Secondary | Events of Hospitalization for Respiratory Ailments or Death | Events (participants who experienced hospitalization for respiratory ailments or died) for respiratory ailments are presented. The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented. | ITT Population (include any randomized participants with treatment assignment according to the planned randomization) | Posted | | Number | | events | | up to 12 weeks after the end of study treatment | | | | ID | Title | Description |
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| OG000 | Placebo | Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG001 | ND-L02-s0201 45 mg | ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG002 | ND-L02-s0201 90 mg | ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. |
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| Secondary | Total Events of Death Due to All Causes | Rate of mortality due to all causes is presented. Overall survival was defined as the time from start of study treatment to death due to any cause. | ITT Population (include any randomized participants with treatment assignment according to the planned randomization) | Posted | | Count of Participants | | Participants | | up to 12 weeks after the end of study treatment | | | | ID | Title | Description |
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| OG000 | Placebo | Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG001 | ND-L02-s0201 45 mg | ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG002 | ND-L02-s0201 90 mg | ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. |
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| Secondary | Events of Deterioration of IPF Resulting in Lung Transplantation or Death and Rate of Deterioration of IPF Resulting in Lung Transplantation | Events of deterioration of Idiopathic Pulmonary Fibrosis (IPF) resulting in lung transplantation (LP; up to 12 weeks after the end of study treatment) or death (weeks) and rate of deterioration of IPF resulting in lung transplantation (up to 12 weeks after the end of study treatment) are presented. Total events = Participants who experience deterioration of IPF resulting in LP (or died). Rate of Deterioration = Rate of Deterioration of IPF Resulting in LP. | ITT Population (include any randomized participants with treatment assignment according to the planned randomization) | Posted | | Number | | events | | Baseline to 12 weeks after end of study treatment | | | | ID | Title | Description |
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| OG000 | Placebo | Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG001 | ND-L02-s0201 45 mg | ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses. | | OG002 | ND-L02-s0201 90 mg | |
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