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

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:
Biomarker Modulation and the Inhibition of Natural Killer Type 1 (NKT1) Cells by Oral GRI-0621 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06331624
Study type Interventional
Source GRI Bio Operations, Inc.
Contact
Status Recruiting
Phase Phase 2
Start date March 2024
Completion date January 2025
View Details
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