Senicapoc in Patients With Worsening Fibrotic Interstitial Lung Disease

Sponsor
Vejle Hospital
Study ID
NCT06714123
Phase
PHASE2
Status
Recruiting
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Conditions

  • Idiopathic Pulmonary Fibrosis
  • Pulmonary Fibrosis, Interstitial Lung Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Senicapoc — DRUG
    administering 30 mg senicapoc a day, in addition to standard of care.
  • Placebo — DRUG
    Tablets similar in size and color

Study Details

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.

Key Dates

First listed
Dec 3, 2024
Start date
Aug 1, 2025
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Senicapoc
    Senicapoc 30 mg per day, administered as 3 tablets of 10 mg,.
  • Placebo Comparator: Placebo
    Tablets similar in size, color and composition, as the active comparator, administered as 3 tablets a day.

Primary Outcome Measure

The rate of decline of forced vital capacity (FVC) in mL of predicted. [ Time Frame: 26 weeks ]

Central Contacts

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