New drug duo aims to help lung fibrosis patients breathe easier
NCT ID NCT07570888
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding nerandomilast to the standard drug mycophenolate is safe and tolerable for people with pulmonary fibrosis (lung scarring). About 120 adults with various types of lung fibrosis will take the combination for 4 months. The main goal is to see how many can stay on the new drug without stopping due to side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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