GRI-0621 for Pulmonary Fibrosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called GRI-0621, a potential drug for idiopathic pulmonary fibrosis (IPF), a lung condition that causes scarring and breathing problems. The main goal is to determine if taking GRI-0621 daily improves symptoms compared to a placebo, which contains no active drug. A sub-study examines certain immune cells in the lungs. Individuals with long-standing IPF who can breathe without excessive supplemental oxygen might be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial requires that if you are already on approved IPF therapies, you must stay on your current medication from the start of the trial until the last study visit. However, you cannot start any new IPF therapies or take oral corticosteroids over 10 mg/day within 4 weeks of the trial's start.
Is there any evidence suggesting that GRI-0621 is likely to be safe for humans?
Research has shown that GRI-0621 is safe and well-tolerated in people so far. In studies, the first 24 patients who took GRI-0621 for six weeks did not experience any safety issues. The data also showed no decrease in lung function during this time, indicating that the treatment does not harm the lungs. This is crucial for patients with lung conditions like idiopathic pulmonary fibrosis (IPF). Overall, the evidence supports that GRI-0621 is safe for use in these short-term studies.12345
Why do researchers think this study treatment might be promising for pulmonary fibrosis?
Unlike the standard treatments for pulmonary fibrosis, which often focus on reducing inflammation or slowing disease progression, GRI-0621 offers a novel approach by utilizing tazarotene, a retinoid. This active ingredient is traditionally used in dermatology but is now being explored for its potential to target specific pathways involved in fibrosis. Researchers are excited about GRI-0621 because it may provide a new way to modify the disease process itself, rather than just managing symptoms. Additionally, its once-daily oral administration makes it a convenient option for patients.
What evidence suggests that GRI-0621 might be an effective treatment for pulmonary fibrosis?
Research shows that GRI-0621, which participants in this trial may receive, may help treat idiopathic pulmonary fibrosis (IPF), a lung disease. In earlier studies, patients experienced a positive trend in reducing lung scarring, a major issue in IPF. After six weeks, lung function did not decline, suggesting the treatment might help maintain lung health. Patients also tolerated the treatment well, and it was safe. Early results from biological markers, which indicate disease presence, support its potential to reduce scarring. These findings are promising for those considering joining a trial for this treatment.13456
Are You a Good Fit for This Trial?
This trial is for people with Idiopathic Pulmonary Fibrosis (IPF), a type of lung scarring. Participants should be diagnosed with IPF to qualify. The summary provided does not include specific inclusion or exclusion criteria, so additional details such as age, disease severity, and other health requirements are unknown.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive GRI-0621 or placebo once daily for 12 weeks
Sub-Study
Examination of NKT cell activity in BAL fluid for up to 12 eligible subjects
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GRI-0621
Find a Clinic Near You
Who Is Running the Clinical Trial?
GRI Bio Operations, Inc.
Lead Sponsor