Interstitial Lung Disease (ILD), Pulmonary Fibrosis
Conditions
Keywords
pulmonary fibrosis, interstitial lung disease, nerandomilast, Mycophenolate mofetil, mycophenolate sodium
Brief summary
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.
Interventions
Participant who are already treated with mycophenolate and have pulmonary fibrosis will receive also treatment with nerandomilast.
Sponsors
University of British Columbia
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any underlying pulmonary fibrosis diagnosis (excluding IPF) with ≥ 10% fibrosis on chest HRCT (performed within 1 year of screening) by volume assessment as determined by the treating physician * Anticipated benefit from nerandomilast therapy as determined by the treating physician (note that previous observed progression as defined in previous PPF clinical trials is not required prior to enrolment) * Stable dose of mycophenolate for the preceding 3 months, with a minimum total daily dose of 1,500mg for mycophenolate mofetil or 1080mg for mycophenolate sodium * Clinically stable for the preceding 6 weeks (did not require addition of corticosteroids for AE-ILD, or any other reason for urgent hospitalization).
Exclusion criteria
* Diagnosis of IPF * Contraindication to treatment with nerandomilast as determined by the treating physician * FVC \< 45% or DLCO \< 25% based on last PFT (must be performed within 3 months of screening) * Use of systemic prednisone \> 10 mg/day for \> 2 weeks within 3 months of screening (initiation of prednisone during the study is permitted if considered clinically indicated in the opinion of the treating physician) * Use of azathioprine, cyclophosphamide, rituximab, and/or tocilizumab within 3 months of screening (initiation of azathioprine, cyclophosphamide, rituximab, and/or tocilizumab during the study is permitted if considered clinically indicated in the opinion of the treating physician) * Use of pirfenidone and/or nintedanib within 6 weeks of screening (initiation of nintedanib and/or pirfenidone during the study is permitted if considered clinically indicated in the opinion of the treating physician) * Significant emphysema (\> 10% volume on HRCT or FEV1/FVC \< lower limit of normal) * Expected survival \< 6 months as determined by the treating physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the persistency of nerandomilast at 4 months when used in combination with mycophenolate in patients with pulmonary fibrosis | Four months | 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 |
Secondary
| Measure | 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 |
| 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 |
Outcome results
None listed