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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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This is a trial designed to evaluate the combination of nerandomilast with mycophenolate across a wide variety of pulmonary fibrosis subtypes, with the aim of providing clinicians with assurance that this is an appropriate therapeutic combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants already receiving treatment with mycophenolate | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerandomilast 18 mg - adult formulation | Drug | Participant who are already treated with mycophenolate and have pulmonary fibrosis will receive also treatment with nerandomilast. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the persistency of nerandomilast at 4 months when used in combination with mycophenolate in patients with pulmonary fibrosis | The primary outcome will be the frequency of persistent nerandomilast use at 4 months, recorded as a dichotomous variable. To account for the proportion of patients with persisting use of nerandomilast at 4 months after baseline, the percentage of days treated will be recorderd based on patient report and verified against drug dispensation records and 4-month pill counts. Pre-specified analyses will include evaluation of rate of discontinuation of nerandomilast across specific variables, including age, sex, body weight, total daily dose of mycophenolate, and total daily dose of mycophenolate adjusted for body weight. This outcome will support the main hypothesis that, when combined with mycophenolate, nerandomilast will achieve a persistency of ≥ 80% ongoing use at 4 months | Four months |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the frequency of adverse events associated with nerandomilast | Four months | |
| Compare rate of change in forced vital capacity (FVC) in patients treated with nerandomilast to pre-treatment rate of change | Four months |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of blood-based biomarkers including telomere length influence on the response to nerandomilast, alongside treatment-associated alterations in DNA methylation, as measured by change in FVC and DLCO. | Additional exploratory analyses will be performed using blood samples that will be collected at baseline and 4 months. This will include whether patients with short telomeres respond similarly to nerandomilast as do patients with normal or long telomeres with respect to the outcomes of rate of decline in FVC and DLCO, assesing changes in epigenetic age pre-/post-treatment and evaluating epigenome-wide DNAm and transcriptomic changes per-/post-treatment. |
Inclusion Criteria:
Exclusion Criteria:
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| Compare rate of change in diffusion capacity of the lung for carbon monoxide (DLCO) in patients treated with nerandomilast to pre-treatment rate of change | Four months |
| Determine the rate of change in patient-reported outcome measures (PROMs) from baseline to month 4 | Four months |
| Four months |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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