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Not yet recruiting 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.

Phase IV Interventional Pulmonary Fibrosis Interstitial Lung Disease (ILD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nerandomilast 18 mg - adult formulation.
Who it may be relevant to
Registry conditions: Pulmonary Fibrosis, Interstitial Lung Disease (ILD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug Nerandomilast 18 mg - adult formulation
    Participant who are already treated with mycophenolate and have pulmonary fibrosis will receive also treatment with nerandomilast.

Primary outcome measures

  • Determine the persistency of nerandomilast at 4 months when used in combination with mycophenolate in patients with pulmonary fibrosis [Time frame: Four months]
Secondary outcome measures (4)
  • Determine the frequency of adverse events associated with nerandomilast [Time frame: Four months]
  • Compare rate of change in forced vital capacity (FVC) in patients treated with nerandomilast to pre-treatment rate of change [Time frame: 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 [Time frame: Four months]
  • Determine the rate of change in patient-reported outcome measures (PROMs) from baseline to month 4 [Time frame: Four months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07570888 · 1305-0168

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗