Biomarker Modulation and the Inhibition of NKT1 Cells in patients with IPF
Research type
Research Study
Full title
Biomarker Modulation and the Inhibition of Natural Killer Type 1 (NKT1) Cells by Oral GRI-0621 in Patients with Idiopathic Pulmonary Fibrosis (IPF)
IRAS ID
1008897
Contact name
Albert Agro
Contact email
Sponsor organisation
GRI Bio Operations, Inc.
Research summary
This clinical research study is for participants with idiopathic pulmonary fibrosis (IPF) and will gather information about whether the study drug GRI-0621 can help reduce inflammation and other symptoms in IPF patients, in a safe and effective way. The study will also investigate how well the study drug is tolerated. The study is a randomised, placebo-controlled, double-blind trial of GRI-0621, and is being conducted at multiple study clinics in the United Kingdom, United States of America, and Australia.
Eligible IPF participants aged 40 to 85 years, inclusive, will be invited to take part. Following informed consent, potential participants will undergo screening assessments to check their eligibility to take part in the study. Eligible participants will be randomly allocated, as with a flip of a coin to receive either GRI-0621, taken orally, once a day for 12 weeks, or a placebo capsule which is a “dummy” capsule which looks like GRI-0621 but not containing any active ingredient. Regular clinic visits will take place during the 12-week treatment period, where several assessments will happen. These assessments include a clinical physical examination, blood sampling (to test for clinical laboratory markers, immune-related markers and pharmacokinetics, which is a measure of how the body handles the study drug), ECG, eye tests, bone density assessment (by DEXA scan), pulmonary function tests (e.g. spirometry) and questionnaires for general patient health and mental wellbeing. There is a further follow up visit 2 weeks after the last dose of treatment.
There is also an optional sub-study which involves a smaller group of participants having a bronchoalveolar lavage (BAL). BAL involves having a bronchoscopy plus a “wash” of part of a lung with saline, and suction of the liquid off the lungs for further assessment. The BAL procedure will take place at screening and at the end of the treatment period, for those participants who consent to being involved.REC name
London - Harrow Research Ethics Committee
REC reference
24/LO/0023
Date of REC Opinion
1 Mar 2024
REC opinion
Further Information Favourable Opinion