Senicapoc treatment for worsening fibrotic interstitial lung disease
Official title: Senicapoc in Patients With Progressive Fibrotic ILD (Interstitial Lung Disease) and IPF (Idiopathic Pulmonary Fibrosis) to Prevent Progression.
Run by Vejle Hospital · NCT06714123 · Data updated 2026-11-12
This trial will test whether senicapoc can slow or stop worsening lung scarring in adults with progressive fibrotic interstitial lung disease, including idiopathic pulmonary fibrosis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 140 (estimated) |
| Sponsor | Vejle Hospital Academic / other |
| Drugs / interventions | imatinib, methotrexate, cyclophosphamide, prednisone |
| Locations | 5 sites (Aarhus N and 4 other locations) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT06714123 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (over 18) with progressive fibrotic interstitial lung disease or progressive IPF, recent HRCT, an FVC above 45%, documented FVC decline of ≥5% over the prior 6–24 months, and ability to walk at least 150 meters on the 6MWT are the intended participants.
✕Probably not a fit
Patients with very advanced lung impairment (for example FVC at or below study cutoffs), predominant emphysema over fibrosis on HRCT, inability to take oral medication, or inability to attend clinic visits are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with progressive fibrotic ILD or progressive IPF will receive either senicapoc or a matching placebo and take three tablets daily for 26 weeks, with follow-up out to 52 weeks. Doctors will monitor lung function, record adverse events, and collect quality-of-life questionnaires across five clinic visits (baseline, week 4, 13, 26 and 52). Eligibility requires prior HRCT, documented recent FVC decline, and the ability to complete a 6-minute walk test and questionnaires. The trial builds on preclinical and animal data suggesting KCa3.1 inhibition may reduce fibrosis and uses placebo control to determine whether those signals translate to patients.
Why it matters
Potential benefit: If successful, senicapoc could slow or halt progression of lung scarring, helping preserve lung function and quality of life for people with progressive fibrotic ILD.
How similar studies have gone: Existing antifibrotic drugs (pirfenidone, nintedanib) have shown benefit in slowing progression, while senicapoc is a novel KCa3.1 blocker with promising preclinical and animal data and limited prior human safety testing but little clinical efficacy data in lung fibrosis so far.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Aarhus University Hospital
Aarhus N, Denmark Recruiting -
Kardiologisk Forskningsenhed 2161, Rigshospitalet
Copenhagen, Denmark Recruiting -
Tartu University Hospital,
Tartu, Estonia Recruiting -
Division of Respiratory Sciences, Glenfield Hospital
Leicester, United Kingdom Recruiting -
University of East Anglia
Norwich, United Kingdom Recruiting
Study contacts
- Study coordinator: Line Kølner-Augustson, MD.
- Email: line.augustson@rsyd.dk
- Phone: +45 28773005
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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New IPF drug ORJ-001 tested in adults with IPF
A phase 2 study tests ORJ-001 versus placebo in adults with idiopathic pulmonary fibrosis to see if it is tolerated and whether it helps lung function.
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This study tests whether extended-release nalbuphine tablets can reduce chronic cough in people with idiopathic pulmonary fibrosis.
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Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients
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Photon-counting CT vs standard HRCT to help diagnose IPF and other ILDs
This study tests whether photon-counting CT can improve identifying IPF and other ILDs compared with standard HRCT for patients discussed in multidisciplinary teams.
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Rentosertib by mouth for people with idiopathic pulmonary fibrosis
This is a randomized, placebo-controlled test to see if Rentosertib helps adults with idiopathic pulmonary fibrosis when taken as a pill.
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Inhaled nintedanib powder for IPF in adults
This study tests whether an inhaled form of nintedanib can safely help adults with idiopathic pulmonary fibrosis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.