FIBROPOC
Research type
Research Study
Full title
Senicapoc in patients with Progressive Fibrotic ILD (Interstitial Lung Disease) and IPF (Idiopathic Pulmonary Fibrosis) to prevent progression – A Randomized, placebo-controlled, double-blind, multi-national multicenter, Phase II Trial.
IRAS ID
1009969
Contact name
Line Kølner-Augustson
Contact email
Sponsor organisation
Sygehus Lillebælt - Vejle
Eudract number
2024-511131-97
Clinicaltrials.gov Identifier
Research summary
Interstitial Lung Disease (ILD) is a group of deadly lunge diseases, that result from scarring of lung tissue and cannot be cured. The best treatments currently available, is only able to slow down disease progression, and this is at the cost of a bunch of side-effects. Senicapoc is a medication that has been shown to counteract scarring in human lung cells from people with ILD. Senicapoc has been proven safe to use in dosages up to 150 mg a day. So far, the studies on humans have not found more side effects in the treatment groups, compared to placebo.
This study will investigate whether Senicapoc can prevent further worsening of ILD.
We aim to include 140 patients with progressive ILD, in 3 different countries. Of those 70 will be receiving Senicapoc 30 mg/day and 70 will be receiving placebo. Both will be in addition to already initiated antifibrotic treatment. When entering the trial, participants will be randomized to either senicapoc or placebo, and neither the participants nor the investigators will know what they receive. The trial will continue for 26 weeks (½ year), and include 3 visits in the outpatient clinic, hereby is only 1 extra (at 3 months) than the usual visits. During the visits participants will be required to answer questionnaires according their quality of life.
Blood-samples will be taken at initiation, and after 4 and 26 weeks. About half will be analyzed for organ values and safety assessment, the rest will be frozen and transferred to a biobank in Denmark for analysis of all blood samples, after end-of-trial.This trial has the purpose to:
• Investigate whether Senicapoc could slow down lung function deterioration in ILD.
• Investigate whether Senicapoc has the potential for protecting against exacerbation and hospitalization.
• Investigate the side effects of Senicapoc
• Investigate whether Senicapoc has an impact on quality-of-life in patients with ILD.REC name
London - Dulwich Research Ethics Committee
REC reference
25/LO/0201
Date of REC Opinion
7 Apr 2025
REC opinion
Further Information Favourable Opinion