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NCT06331624

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

Biomarker Modulation and the Inhibition of Natural Killer Type 1 (NKT1) Cells by Oral GRI-0621 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
GRI Bio Operations, Inc.·Phase 2·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Idiopathic Pulmonary Fibrosis
Drug/Device/Intervention
Tazarotene (GRI-0621)
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
GRI Bio Operations, Inc.
Location
Newport Beach,Winston-Salem, United States of America
Timeline & enrollment
Phase
Phase 2
Start date
Mar 01, 2024
End date
Jan 01, 2025
Enrollment
36 participants
Primary outcome

Safety and Tolerability of oral GRI-0621

Summary

This is a Phase 2a, randomized, double-blind, multi-center, placebo-controlled,
 parallel-design, 2-arm study. Approximately 36 subjects with IPF will be randomized in a 2:1
 ratio for GRI-0621 4.5mg or Placebo. GRI-0621 dose of 4.5mg will be compared with placebo
 following once daily oral administration for 12 weeks. Concurrently, a Sub-Study will be
 conducted, examining the number and activity of NKT cells in BAL, for up to 12 eligible
 subjects (across various centers). An interim analysis will be performed when 24 subjects
 complete 6 weeks of treatment (approximately 8 placebo subjects).

ICD-10 classifications
Other interstitial pulmonary diseases with fibrosisCystic fibrosis with pulmonary manifestationsCystic fibrosisGraphite fibrosis (of lung)Pulmonary heart disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06331624
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06331624 through Pure Global AI's free database. This Phase 2 trial is sponsored by GRI Bio Operations, Inc. and is currently Recruiting. The study focuses on Idiopathic Pulmonary Fibrosis. Target enrollment is 36 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.