Actively Recruiting
Senicapoc in Patients With Worsening Fibrotic Interstitial Lung Disease
Led by Vejle Hospital · Updated on 2026-05-07
140
Participants Needed
5
Research Sites
174 weeks
Total Duration
On this page
Sponsors
V
Vejle Hospital
Lead Sponsor
O
Odense Patient Data Explorative Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Senicapoc in Patients With Worsening Fibrotic Interstitial Lung Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with progressive fibrotic interstitial lung disease or progressive idiopathic pulmonary fibrosis according to guidelines
- Age over 18 years
- High-resolution CT scan done within the past 24 months
- Forced vital capacity (FVC) greater than 45% predicted
- Forced expiratory volume in 1 second (FEV1) / FVC ratio greater than 0.7 or above the lower limit of normal
- Annual decline in FVC of at least 5% predicted based on at least three measurements within 6-24 months before enrollment
- Able to provide informed consent
- Extent of fibrotic changes greater than emphysema on the most recent CT scan
- Male participants of reproductive potential agree to use effective contraception during and for 90 days after the study
- Female participants agree to use effective contraception during the study and have a negative pregnancy test before enrollment
- Able to walk at least 150 meters during the 6-minute walk test at screening
- Able to read and complete quality of life questionnaires (EQ-5D, SGRQ-I, K-BILD)
You will not qualify if you...
- Diagnosis of sickle cell disease
- Any condition that may make participation unsuitable or lead to inability to complete the study
- Known allergy or significant reaction to study drug ingredients
- Current immunosuppressive condition
- Significant abnormalities on ECG affecting rhythm or conduction
- Moderate to severe liver impairment or abnormal liver function tests at screening
- Blood tests showing cholestasis with bile acid levels more than three times the upper limit
- Abnormal kidney function defined as eGFR less than or equal to 30 ml/min
- History of cancer within the past 5 years
- Participation in another clinical study with investigational drugs for fibrotic disease within the last 6 months
- Participation in another interventional study or use of investigational agents within five half-lives
- Lower respiratory tract infection requiring treatment within 4 weeks before screening or during screening
- History of lung volume reduction surgery or lung transplant
- Severe pulmonary hypertension diagnosis
- Unstable cardiovascular, pulmonary (other than IPF), or other disease within 6 months before or during screening
- Use of certain specified therapies within 4 weeks before or during screening or planned during the study (e.g., warfarin, imatinib, ambrisentan, azathioprine, cyclophosphamide, cyclosporine A, bosentan, methotrexate, sildenafil except occasional use, prednisone over 10 mg/day or equivalent)
- Current alcohol or substance abuse as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Aarhus University Hospital
Aarhus N, Denmark, 8200
Actively Recruiting
2
Kardiologisk Forskningsenhed 2161, Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
3
Tartu University Hospital,
Tartu, Estonia, 50406
Actively Recruiting
4
Division of Respiratory Sciences, Glenfield Hospital
Leicester, United Kingdom, LE3 9QP
Not Yet Recruiting
5
University of East Anglia
Norwich, United Kingdom, NR4 7TJ
Not Yet Recruiting
Research Team
L
Line Kølner-Augustson, MD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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