Pulmonary Fibrosis, Interstitial Lung DiseasePhase 2FIBROPOCNCT06714123
Senicapoc in Patients With Worsening Fibrotic Interstitial Lung Disease
A Phase 2 study testing Senicapoc in people with Pulmonary Fibrosis, Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis, run by Vejle Hospital at 5 sites in 3 countries.
Trial summary
This study will investigate whether the senicapoc drug can prevent the scarring from worsening in interstitial lung disease. Researchers will compare Senicapoc to a placebo (a look-alike substance that contains no drug) to see if Senicapoc works to prevent lung function worsening. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Fibrosis, Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis
- What is being tested?
- Senicapoc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 1 Aug 2025to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 3 countries
Denmark2 sites, 2 recruiting
- Recruiting
Aarhus University Hospital
Aarhus N, 8200
Elisabeth Bendstrup, Professor, +4521744562, kabend@rm.dk
- Recruiting
Kardiologisk Forskningsenhed 2161, Rigshospitalet
Copenhagen, 2100
Rikke Brandt Forskningssygeplejerske, +45 35 45 84 30, rikke.brandt@regionh.dk
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
Division of Respiratory Sciences, Glenfield Hospital
Leicester, LE3 9QP
Peter Bradding professor, 0116 2583998, pb46@leicester.ac.uk
- Not yet recruiting
University of East Anglia
Norwich, NR4 7TJ
Andrew Wilson Professor, 01603 591257, A.M.Wilson@uea.ac.uk
Estonia1 site, 1 recruiting
- Recruiting
Tartu University Hospital,
Tartu, 50406
Alan B Altraja, Professor, +3727318901, alan.altraja@ut.ee
About this study
Official title: Senicapoc in Patients With Progressive Fibrotic ILD (Interstitial Lung Disease) and IPF (Idiopathic Pulmonary Fibrosis) to Prevent Progression.
This study will investigate whether the senicapoc drug can prevent the scarring from worsening in interstitial lung disease.
Researchers will compare Senicapoc to a placebo (a look-alike substance that contains no drug) to see if Senicapoc works to prevent lung function worsening.
Participants will be asked to take 3 tablets a day for 26 weeks. Within this period, doctors will follow the participants, ask for experience of adverse events, check lung function and organ status, and participants will need to fill out quality-of-life questionnaires. A total of 5 visits are required, at initiation, after4, 13, 26 and 52 weeks. The final visit will occur 52 weeks after initiation and consist of a normal visit in the outpatient clinic where the doctor asks for relevant information regarding the period after end of administration of the study drug.
Read the detailed description
Background: Fibrosing interstitial lung disease (F-ILD) represents a heterogeneous group of chronic, severely debilitating, and ultimately lethal lung diseases with limited treatment options. The common denominator for F-ILD is similarities regarding development of scarring of the lungs. Two antifibrotic treatments (pirfenidone, nintedanib), have shown to improve progression free survival, and slowed the decline in forced ventilatory capacity (FVC). These treatments are currently approved in the European Union and are standard of care for many patients. But both treatments have a lot of unbeneficial side-effects, making it unbearable for many patients to receive full dose treatment and often patients progress despite antifibrotic treatment.
Senicapoc is a selective and highly potent inhibitor of KCa3.1 channels. The KCa3.1 channel is pivotal in Ca+ signaling and plays a central role in fibroblast processes. It is therefore thought to play an important role in the development of many fibrotic diseases, including lung fibrosis. Two lines of evidence using human lung cells and lung slices indicate that blocking of the KCa3.1 channel attenuates many profibrotic activities and support the expected antifibrotic effect of senicapoc. In sheep studies, senicapoc has shown not only to attenuate disease progression but also signs of reversing the disease. It has been extensively tested in animal studies and shown no toxic or unbeneficial effects, and it has been tested in human studies in healthy volunteers, patients with sickle cell disease, asthma, and COVID-19, without revealing any serious adverse reactions.
Aims, Objectives and hypothesis: The aim of this study is to investigate the effect of senicapoc in preventing progression in F-ILD. Evaluation will consist of spirometry, 6-minute walking distance test and diffusion capacity. Sidewise changes in quality of life and degree of dyspnea will be obtained. Clinical examinations and bloodtests will be done to evaluate a second aim of this study; the safety of senicapoc in IPF patients.
The hypothesis is that senicapoc is safe, without any major adverse reactions, and has a valuable effect in preventing progression in fibrotic ILD.
Patients diagnosed with fibrotic ILD and shown to progress despite standard of care are candidates. Patients must have an F-ILD diagnosis within 5 years, and an HRCT scan within the previous 24 months. In addition to this, patients must have shown disease progression within the last year, and with no more additional antifibrotic treatment options available. Patients will be recruited from the outpatient clinic. A total of 140 participants will be included, distributed between 6 different sites.
Intervention: Participants will be randomly assigned to one of two groups to receive either senicapoc 30mg/day or placebo in addition to their usual antifibrotic treatment, if any. The tablets containing the active ingredient will have a dosage of 10 mg each, while the placebo tablets are manufactured to resemble the active ingredient tablets in terms of size, color, and design. Participants will be examined at initiation, after 4, 13 and 26 weeks of study drug intake. In addition blood test will be drawn at 0, 4 and 26 weeks. The main trial endpoint is rate of decline of FVC (in mL) over a period of 26 weeks. A final observation will be caried out at week 52, including blood safety assesment.
- Being tested
- Senicapoc, Placebo
- Keywords
- pulmonary fibrosis, Senicapoc, interstitial lung disease
- Medical subject headings
- Pulmonary Fibrosis, Lung Diseases, Interstitial, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SenicapocDrug
administering 30 mg senicapoc a day, in addition to standard of care.
PlaceboDrug
Tablets similar in size and color
| Study group | Role | What they receive |
|---|---|---|
| Senicapoc | Active comparator | Senicapoc 30 mg per day, administered as 3 tablets of 10 mg,. Receives: Drug: Senicapoc |
| Placebo | Placebo comparator | Tablets similar in size, color and composition, as the active comparator, administered as 3 tablets a day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of decline of forced vital capacity (FVC) in mL of predicted.
Between baseline and 26 weeks
Measured: 26 weeks
Secondary outcomes (5)
The rate of decline of forced vital capacity (FVC) in % of predicted.
Between baseline and 26 weeks.
Measured: 26 weeks
All cause mortality
Measured: 26 weeks
Time to first respiratory-related hospitalization
Measured: 26 weeks
Number and degree of adverse events after 26 weeks of treatment.
Evaluation of the amount and type of adverse events during the study, and their relation to the study drug
Measured: 26 weeks
Change in the quality of life after 26 weeks of treatment
Measured using specific validated questionnaires
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start1 Aug 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Fibrosis, Interstitial Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, International
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Odense Patient Data Explorative Network
- Responsible party
- Sponsor
- Investigators
- Ole Hilberg, Proffesor, Study director, Sygehus Lillebælt - Vejle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714123
- Sponsor's protocol ID
- Fibropoc
- Other IDs
- NNF21OC0071860, 2024-511131-97-00, IRAS 1009969
- Acronym
- FIBROPOC
- Status last verified
- May 2026
- First submitted
- 26 Nov 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Procedures, including re-coding of key variables, will be put in place to allow for complete de-identification of the data. All relevant trial-related documents, including the protocol, data dictionary, and the main statistical code, will be made available for sharing along with the data. Data will be completely anonymized according to European law. The method for datasharing has yet to be decided.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Senicapoc in Patients With Progressive Fibrotic ILD (Interstitial Lung Disease) and IPF (Idiopathic Pulmonary Fibrosis) to Prevent Progression.
- ClinicalTrials.gov ID
- NCT06714123
- Acronym / sponsor ID
- FIBROPOC / Fibropoc
- Keywords
- pulmonary fibrosis, Senicapoc, interstitial lung disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Collaborators
- Odense Patient Data Explorative Network
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate whether the senicapoc drug can prevent the scarring from worsening in interstitial lung disease.
Researchers will compare Senicapoc to a placebo (a look-alike substance that contains no drug) to see if Senicapoc works to prevent lung function worsening.
Participants will be asked to take 3 tablets a day for 26 weeks. Within this period, doctors will follow the participants, ask for experience of adverse events, check lung function and organ status, and participants will need to fill out quality-of-life questionnaires. A total of 5 visits are required, at initiation, after4, 13, 26 and 52 weeks. The final visit will occur 52 weeks after initiation and consist of a normal visit in the outpatient clinic where the doctor asks for relevant information regarding the period after end of administration of the study drug.
Detailed description
Background: Fibrosing interstitial lung disease (F-ILD) represents a heterogeneous group of chronic, severely debilitating, and ultimately lethal lung diseases with limited treatment options. The common denominator for F-ILD is similarities regarding development of scarring of the lungs. Two antifibrotic treatments (pirfenidone, nintedanib), have shown to improve progression free survival, and slowed the decline in forced ventilatory capacity (FVC). These treatments are currently approved in the European Union and are standard of care for many patients. But both treatments have a lot of unbeneficial side-effects, making it unbearable for many patients to receive full dose treatment and often patients progress despite antifibrotic treatment.
Senicapoc is a selective and highly potent inhibitor of KCa3.1 channels. The KCa3.1 channel is pivotal in Ca+ signaling and plays a central role in fibroblast processes. It is therefore thought to play an important role in the development of many fibrotic diseases, including lung fibrosis. Two lines of evidence using human lung cells and lung slices indicate that blocking of the KCa3.1 channel attenuates many profibrotic activities and support the expected antifibrotic effect of senicapoc. In sheep studies, senicapoc has shown not only to attenuate disease progression but also signs of reversing the disease. It has been extensively tested in animal studies and shown no toxic or unbeneficial effects, and it has been tested in human studies in healthy volunteers, patients with sickle cell disease, asthma, and COVID-19, without revealing any serious adverse reactions.
Aims, Objectives and hypothesis: The aim of this study is to investigate the effect of senicapoc in preventing progression in F-ILD. Evaluation will consist of spirometry, 6-minute walking distance test and diffusion capacity. Sidewise changes in quality of life and degree of dyspnea will be obtained. Clinical examinations and bloodtests will be done to evaluate a second aim of this study; the safety of senicapoc in IPF patients.
The hypothesis is that senicapoc is safe, without any major adverse reactions, and has a valuable effect in preventing progression in fibrotic ILD.
Patients diagnosed with fibrotic ILD and shown to progress despite standard of care are candidates. Patients must have an F-ILD diagnosis within 5 years, and an HRCT scan within the previous 24 months. In addition to this, patients must have shown disease progression within the last year, and with no more additional antifibrotic treatment options available. Patients will be recruited from the outpatient clinic. A total of 140 participants will be included, distributed between 6 different sites.
Intervention: Participants will be randomly assigned to one of two groups to receive either senicapoc 30mg/day or placebo in addition to their usual antifibrotic treatment, if any. The tablets containing the active ingredient will have a dosage of 10 mg each, while the placebo tablets are manufactured to resemble the active ingredient tablets in terms of size, color, and design. Participants will be examined at initiation, after 4, 13 and 26 weeks of study drug intake. In addition blood test will be drawn at 0, 4 and 26 weeks. The main trial endpoint is rate of decline of FVC (in mL) over a period of 26 weeks. A final observation will be caried out at week 52, including blood safety assesment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, International
| Arm | Type | Receives |
|---|---|---|
| Senicapoc | Active comparator | Drug: SenicapocSenicapoc 30 mg per day, administered as 3 tablets of 10 mg,. |
| Placebo | Placebo comparator | Drug: PlaceboTablets similar in size, color and composition, as the active comparator, administered as 3 tablets a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (17 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Senicapocadministering 30 mg senicapoc a day, in addition to standard of care. | Drug | Senicapoc |
| PlaceboTablets similar in size and color | Drug | Placebo |
Primary outcome
The rate of decline of forced vital capacity (FVC) in mL of predicted.
Time frame: 26 weeks
Between baseline and 26 weeks
5 secondary outcomes
The rate of decline of forced vital capacity (FVC) in % of predicted.
Time frame: 26 weeks
All cause mortality
Time frame: 26 weeks
Time to first respiratory-related hospitalization
Time frame: 26 weeks
Number and degree of adverse events after 26 weeks of treatment.
Time frame: 26 weeks
Change in the quality of life after 26 weeks of treatment
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Yes. Procedures, including re-coding of key variables, will be put in place to allow for complete de-identification of the data. All relevant trial-related documents, including the protocol, data dictionary, and the main statistical code, will be made available for sharing along with the data. Data will be completely anonymized according to European law. The method for datasharing has yet to be decided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ole Hilberg, Proffesor study director
Sygehus Lillebælt - Vejle
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Senicapoc in people with Pulmonary Fibrosis, Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis, run by Vejle Hospital at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark, United Kingdom, Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Line Kølner-Augustson, MD. (+45 28773005, line.augustson@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of decline of forced vital capacity (FVC) in mL of predicted. (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.