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. (NERAM-PF)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Fibrosis; Interstitial Lung Disease (ILD)
• Intervention / Treatment: Drug: Nerandomilast 18 mg - adult formulation

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants already receiving treatment with mycophenolate	Drug: Nerandomilast 18 mg - adult formulation; Participant who are already treated with mycophenolate and have pulmonary fibrosis will receive also treatment with nerandomilast.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome 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

Other Outcome Measures

Outcome Measure	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.	Four months

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Boehringer Ingelheim

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: May 1, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: interstitial lung disease; Mycophenolate mofetil; pulmonary fibrosis; mycophenolate sodium; nerandomilast
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pathological Conditions, Signs and Symptoms; Pulmonary Fibrosis; Lung Diseases, Interstitial
• Other Study ID Numbers: 1305-0168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No