Could a simple pill stop lungs from scarring? new trial launches
NCT ID NCT06714123
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether the drug senicapoc can prevent lung scarring from getting worse in people with progressive fibrotic interstitial lung disease (ILD) or idiopathic pulmonary fibrosis (IPF). About 140 adults will take either senicapoc or a placebo daily for 26 weeks, and doctors will track lung function, side effects, and quality of life. The goal is to see if senicapoc can slow the decline in breathing capacity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Senicapoc (a drug taken as tablets)
- What this could lead to
- If it works, this could point toward a new treatment to slow lung scarring and preserve breathing function in people with fibrotic lung disease.
- What could go wrong
- This is an early Phase 2 trial with only 140 participants, so results may not confirm benefit. The drug may cause side effects or fail to outperform placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 2028
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: * Progressive fibrotic ILD or Progressive IPF diagnosed according to ATS/ERS/JRS/ALAT guidelines at the time of diagnosis * Age \> 18 years * HRCT historically performed within 24 months * FVC \> 45 %, FEV1/FVC \> 0,7 or above LLN * Annual FVC decline of at least 5% predicted, based on at least three FVC measurements within 6-24 months before enrolment * Subject able to give informed consent. * The extent of fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan * Male subjects of reproductive potential agree to use highly effective contraception/preventive exposure measures from the time of first dose of IMP during the study, and until 90 days (male) after the last dose of IMP. * Female subjects agree to use highly effective contraceptive during the study, and must show a negative pregnancy test before inclution. * Able to walk at least 150 meters during the 6MWT at screening Visit 1; * Able to read and complete the EQ-5D, SGRQ-I, K-BILD questionnaire. Exclusion Criteria: * Sickle cell disease * Any clinical condition or other condition or circumstance that, in the opinion of the investigator, may make a subject unsuitable for inclusion or unlikely or unable to complete the study or comply with study procedures and requirements. * Known hypersensitivity to any of the IMP ingredients or a history of a significant allergic reaction to any drug as determined by the investigator * A current immunosuppressive condition * Clinically significant abnormalities detected on ECG of either rhythm or conduction, * Moderate to severe hepatic impairment (Child-Pugh B or C); and/or abnormal LFT at screening, * Clinical laboratory test suggestive of cholestasis with total serum bile acid levels \> 3xULN. * Abnormal renal function, defined as eGFT \> 30 ml/kg * History of malignancy within the past 5 years * Previous participation in a clinical study with IMP for fibrotic disease within the last 6 months. * Concurrent participation in another interventional drug, device, or biological investigational research study, or use of an investigational agent within 5 half-lives of the agent * Lower respiratory tract infection requiring treatment within 4 weeks prior to screening and/or during the screening period. * History of lung volume reduction surgery or lung transplant. * Diagnosis of severe pulmonary hypertension * Unstable cardiovascular, pulmonary (other than IPF), or other disease within 6 months prior to screening or during the screening period * Use of any of the following therapies within 4 weeks prior to screening and during the screening period, or planned during the study: warfarin, imatinib, ambrisentan, azathioprine, cyclophosphamide, cyclosporine A, bosentan, methotrexate, sildenafil (except for occasional use), prednisone at steady dose \> 10 mg/day or equivalent. * Current alcohol or substance abuse in the opinion of the investigator.
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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 places running it
5 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
Contacts and locations
Locations
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Aarhus University Hospital
RECRUITINGAarhus N, 8200, Denmark
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Division of Respiratory Sciences, Glenfield Hospital
NOT_YET_RECRUITINGLeicester, LE3 9QP, United Kingdom
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Kardiologisk Forskningsenhed 2161, Rigshospitalet
RECRUITINGCopenhagen, 2100, Denmark
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Tartu University Hospital,
RECRUITINGTartu, 50406, Estonia
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University of East Anglia
NOT_YET_RECRUITINGNorwich, NR4 7TJ, United Kingdom
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