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.
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).
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)
Single group
Nerandomilast 18 mg - adult formulation
DrugParticipant who are already treated with mycophenolate and have pulmonary fibrosis will receive also treatment with nerandomilast.
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
Determine the frequency of adverse events associated with nerandomilast
Compare rate of change in forced vital capacity (FVC) in patients treated with nerandomilast to pre-treatment rate of change
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
Determine the rate of change in patient-reported outcome measures (PROMs) from baseline to month 4
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.
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University of British Columbia
Lead sponsor
Boehringer Ingelheim
Collaborator
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