Health TrialsbyHealthPanel

Senicapoc in Patients With Worsening Fibrotic Interstitial Lung Disease

ConditionsPulmonary Fibrosis, Interstitial Lung DiseaseIdiopathic Pulmonary Fibrosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVejle Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Senicapoc

    Drug

    administering 30 mg senicapoc a day, in addition to standard of care.

  • Placebo

    Drug

    Tablets similar in size and color

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: SenicapocActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The rate of decline of forced vital capacity (FVC) in mL of predicted.

Between baseline and 26 weeks

Time frame
26 weeks

Secondary outcomes

1

The rate of decline of forced vital capacity (FVC) in % of predicted.

Between baseline and 26 weeks.

Time frame
26 weeks
2

All cause mortality

Time frame
26 weeks
3

Time to first respiratory-related hospitalization

Time frame
26 weeks
4

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

Time frame
26 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vejle Hospital

Lead sponsor

Odense Patient Data Explorative Network

Collaborator

Source ClinicalTrials.gov
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