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.

Nerandomilast Added to Mycophenolate for Treatment of Pulmonary Fibrosis (NERAM-PF).

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.

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