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GRI-0621 for Idiopathic 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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks and 12 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and Tolerability of oral GRI-0621

Secondary outcome measures

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 outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

GRI Bio Operations, Inc.Lead Sponsor

1 Previous Clinical Trials

14 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would it be possible for me to participate in this medical study?

"In order to qualify for participation, individuals must have idiopathic pulmonary fibrosis and fall within the age range of 40 to 85 years. This research study aims to enroll approximately 36 eligible candidates."

Answered by AI

What is the collective count of individuals actively involved in this research trial?

"Indeed, as indicated on clinicaltrials.gov, this research endeavor is presently seeking eligible participants. Originally shared on March 1st, 2024 and last revised on March 19th, the study aims to enroll a total of 36 patients distributed across two distinct sites."

Answered by AI

Has the FDA granted approval for GRI-0621?

"The safety of GRI-0621 is rated 2 by our team at Power due to this being a Phase 2 trial, indicating some evidence supporting its safety but none backing efficacy."

Answered by AI

Does this medical research study include individuals above the age of 35?

"Patients aged between 40 and 85 are sought for participation in this research endeavor. Notably, there are specifically designated clinical trials available for individuals under 18 years old (a total of 67 studies) and those over the age of 65 (comprising a sum of 366 trials)."

Answered by AI

Is the enrollment process currently open for this research study?

"Affirmative. Details on clinicaltrials.gov reveal that this research endeavor is actively seeking suitable candidates. The trial was first listed on 3/1/2024 and most recently revised on 3/19/2024. A total of 36 individuals are sought from two distinct sites for enrollment in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients With IPF

2024. "Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients With IPF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06331624.

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