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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: GRI Bio Operations, Inc. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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 early-stage patient variability assessment will be completed when 12 subjects have completed 2 weeks of treatment. Followed by an interim analysis performed when 24 subjects complete 6 weeks of treatment.

Conditions

• Idiopathic Pulmonary Fibrosis
• IPF

Interventions

Type	Name	Description
DRUG	Tazarotene (GRI-0621)	Oral 4.5mg soft gel capsule
DRUG	Placebo	Oral 4.5mg soft gel capsule

Timeline

• Start date: 2024-04-24
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2024-03-26
• Last updated: 2025-10-30

Locations

16 sites across 3 countries: United States, Australia, United Kingdom

Regulatory

• FDA-regulated drug study