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NCT Number: NCT07570888

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.

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nerandomilast 18 mg - adult formulation

Drug

Participant who are already treated with mycophenolate and have pulmonary fibrosis will receive also treatment with nerandomilast.

Primary outcomes

  1. Determine the persistency of nerandomilast at 4 months when used in combination with mycophenolate in patients with pulmonary fibrosis

    Time frame: 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 outcomes

  1. Determine the frequency of adverse events associated with nerandomilast

    Time frame: Four months

  2. Compare rate of change in forced vital capacity (FVC) in patients treated with nerandomilast to pre-treatment rate of change

    Time frame: Four months

  3. 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

    Time frame: Four months

  4. Determine the rate of change in patient-reported outcome measures (PROMs) from baseline to month 4

    Time frame: Four months

Other outcomes

  1. 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.

    Time frame: Four months

    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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Boehringer Ingelheim

Registry information

Official study title

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

Acronym: NERAM-PF

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 6, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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