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GRI-0621 for Pulmonary Fibrosis

Phase 2
Recruiting
Research Sponsored by GRI Bio Operations, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks and 12 weeks

Summary

This trial is testing a new drug called GRI-0621 in patients with idiopathic pulmonary fibrosis (IPF). It is a Phase 2a study where 36 subjects will be randomly

Who is the study for?
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.
What is being tested?
The study tests the effects of an oral drug called GRI-0621 versus a placebo in patients with IPF. It's a double-blind study, meaning neither the researchers nor participants know who gets the real drug or placebo. The treatment lasts for 12 weeks and includes monitoring natural killer T (NKT) cells in some subjects.
What are the potential side effects?
Potential side effects aren't listed here but could include reactions typical of new medications targeting immune cells like NKT cells—such as flu-like symptoms, fatigue, gastrointestinal issues or skin reactions—but this would need confirmation from detailed trial information.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks and 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and Tolerability of oral GRI-0621
Secondary study objectives
Change from baseline biomarkers
Pharmacodynamics of GRI-0621 in BAL fluid (Optional Sub-Study)
Pharmacodynamics of GRI-0621 in blood (Study Population)
+1 more
Other study objectives
Exploratory - Pulmonary Function

Trial Design

2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Placebo 4.5mg, administered orally once daily (QD)
Group II: GRI-0621Experimental Treatment1 Intervention
GRI-0621 (tazarotene) 4.5mg, administered orally once daily (QD)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

GRI Bio Operations, Inc.Lead Sponsor
1 Previous Clinical Trials
14 Total Patients Enrolled
~4 spots leftby Jan 2025
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