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Senicapoc

Clinical trials are investigating Senicapoc in people with progressive fibrotic interstitial lung disease. These studies are looking at safety and how well it may work compared with placebo, with the main goal of measuring lung function decline over time.

Table of Contents

Trial overview

The available trial of Senicapoc is an interventional study in people with progressive fibrotic interstitial lung disease.[1]

This trial is in Phase 2, which means it is testing whether the treatment may help and is still checking safety and benefit in a defined patient group.[1]

The study status is Authorised, and the planned enrollment is 140 participants.[1]

Condition and target population

The trial is focused on progressive fibrotic interstitial lung disease, a set of lung diseases where scarring in the lungs gets worse over time.[1]

The target population is subjects with this condition, so the study is designed for people who already have progressive fibrotic interstitial lung disease rather than for the general public.[1]

Study design and treatment groups

This is an interventional trial, meaning researchers give a study treatment and compare outcomes between groups.[1]

Participants are assigned to Senicapoc or placebo, and both groups also receive local standard of care.[1]

The study drug is listed as Senicapoc 30 mg by oral use, while the comparison group receives placebo by oral use.[1]

A placebo is a look-alike treatment that does not contain the active study drug, which helps researchers see whether any change is due to the study treatment itself.[1]

Main outcome being measured

The main endpoint is the rate of decline of FVC over 26 weeks.[1]

FVC stands for forced vital capacity, a breathing test that shows how much air a person can blow out after taking a deep breath.[1]

By measuring how quickly FVC goes down, the trial is trying to understand whether Senicapoc may help slow lung function loss in this disease.[1]

The brief study summary also states that the trial is evaluating both safety and efficacy, which means it is looking at whether the treatment can be used safely and whether it may work better than placebo.[1]

What this means for patients

For patients, this trial is mainly about whether Senicapoc can help slow worsening lung function in progressive fibrotic interstitial lung disease.[1]

Because the study uses a placebo comparison, not everyone in the trial will receive Senicapoc, and this helps make the results more reliable.[1]

The study is still relatively early in development, so the main goal is to learn more about how well it works and to continue collecting safety information in the planned group of 140 participants.[1]

Trial ID Phase Condition studied Status Enrollment
2024-511131-97-00 Phase 2 Progressive Fibrotic Interstitial Lung Disease Authorised 140

FAQ

  • What is being studied in the Senicapoc trials? The trial is studying Senicapoc compared with placebo in people with progressive fibrotic interstitial lung disease. It is looking at whether Senicapoc can help slow the decline in lung function.
  • Who can take part in these trials? The trial is for subjects with progressive fibrotic interstitial lung disease. Enrollment is planned for 140 people.
  • What phase is the Senicapoc trial? This is a Phase 2 trial. Phase 2 studies usually look more closely at whether a treatment works and continue to check safety.
  • What result is the trial measuring? The main result is the rate of decline of forced vital capacity, or FVC, over 26 weeks. FVC is a lung test that measures how much air a person can breathe out after taking a deep breath.
  • Is Senicapoc being compared with another treatment? Yes. The study compares Senicapoc with placebo. A placebo looks like a treatment but does not have the active study drug.

Ongoing Clinical Trials on Senicapoc

  • Study on Senicapoc for Patients with Progressive Fibrotic Interstitial Lung Disease to Prevent Disease Progression

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark Estonia

Glossary

  • Progressive fibrotic interstitial lung disease: A group of lung diseases where scar tissue builds up in the lungs and keeps getting worse over time.
  • Phase 2: A mid-stage clinical trial that checks whether a treatment may work and continues to watch for safety.
  • Placebo: A treatment that looks like the study drug but does not contain the active medicine.
  • Interventional study: A study where researchers give a treatment and compare results between groups.
  • Forced vital capacity (FVC): A breathing test that measures how much air a person can force out after taking the deepest breath possible.
  • Rate of decline: How quickly a measurement gets worse over time.
  • Local standard of care: The usual treatment or care already given in the study setting.
  • Enrollment: The number of people planned to join a clinical trial.
  • Authorised: The trial has been approved to move forward.

References

  1. https://clinicaltrials.gov/study/2024-511131-97-00