Recipient organisationNIHR Oxford Clinical Research Facility
NIHR supportRecorded as supported by this research centre
PeriodMar 2025 — Nov 2025
In plain English
AI plain-English summary
Patients with idiopathic pulmonary fibrosis (IPF) will swallow a daily capsule of the experimental drug GRI-0621 for 12 weeks to see if it can safely reduce lung inflammation and other symptoms. IPF is a progressive, scarring lung disease with few effective treatments. Current therapies slow decline but do not reverse damage, and many patients face worsening breathlessness and reduced quality of life. This trial tests whether GRI-0621, taken orally, can modulate specific immune cells—natural killer type 1 (NKT1) cells—that are thought to drive inflammation in the lungs. The study is randomised, placebo-controlled, and double-blind, meaning neither patients nor doctors know who receives the active drug. Researchers will track changes through blood tests, lung function tests, eye exams, bone density scans, and questionnaires on health and mental wellbeing. An optional subgroup will also undergo bronchoalveolar lavage—a lung wash—to directly measure immune markers in the airways. If GRI-0621 proves safe and effective, it could offer a new, convenient oral treatment option for IPF, potentially slowing disease progression and improving daily breathing for thousands of patients. Even if the drug fails, the detailed immune profiling from this trial will clarify which biological pathways matter most in IPF, guiding future drug development.
View original technical description
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.
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