Idiopathic Pulmonary Fibrosis Clinical Trial
Official title:
A Randomised, Placebo-controlled, Double-blind, Repeat Dose Escalation Study With GSK2126458 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
This is a dose escalation/dose finding, double-blind, placebo-controlled, parallel study of
GSK2126458 in subjects with IPF. The study is designed to explore a number of doses of
GSK2126458 for engagement of pharmacology after short term dosing. It is anticipated that
approximately 24 subjects will be enrolled in this study. Actual number of cohorts in this
study could vary up to a maximum of 6 cohorts (n=4/cohort; 3 on active and 1 on placebo).
Each cohort will consist of four subjects who will be randomised to receive GSK2126458 (three
subjects) or placebo (one subject) for approximately 8 days (7 to 10 days). On Day 1 they
will receive their first dose of GSK2126458 (or placebo) and safety, tolerability and PK/PD
in the blood will be measured for up to 8 hours post-dose. Subjects will then be discharged
from the site with study drug until the last day of dosing. They will also receive hand held
spirometers and instructions on action to be taken in case of deterioration in pulmonary
function or any other adverse events (AEs). On the last day of dosing they will return to the
site for a repeat of the Day 1 procedures.
A bronchoalveolar lavage (BAL) and [18F]-fluoro-deoxyglucose (FDG)- positron emission
tomography / computed tomography (PET/CT) scan will be conducted twice during the study;
once, at least 2 days before dosing commences and again during the course of the dosing
period.
After the final subject in each cohort has completed dosing, a dose escalation meeting will
take place. Safety and tolerability and PK data will be reviewed during this meeting and
decisions made may include but are not limited to: escalate the dose, decrease the dose or
repeat the same dose in the next cohort; stop the study.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05984992 -
The First-in-human Study of SRN-001 in Healthy Participants
|
Phase 1 | |
| Active, not recruiting |
NCT04312594 -
Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis
|
Phase 2 | |
| Recruiting |
NCT03865927 -
GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis
|
Phase 2 | |
| Completed |
NCT03979430 -
Early Detection of Acute Exacerbation in Patients With Idiopathic Lung Fibrosis - a Pilot Study
|
N/A | |
| Enrolling by invitation |
NCT04905693 -
Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
|
Phase 3 | |
| Not yet recruiting |
NCT06241560 -
A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood
|
Phase 2 | |
| Terminated |
NCT04419558 -
Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
|
Phase 3 | |
| Completed |
NCT03725852 -
A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF)
|
Phase 2 | |
| Terminated |
NCT03573505 -
An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis
|
Phase 2 | |
| Recruiting |
NCT04148157 -
Quality of Life in IPF - Patient and Physician Perceptions
|
||
| Completed |
NCT03222648 -
Structured Exercise Training Programme in Idiopathic Pulmonary Fibrosis
|
N/A | |
| Not yet recruiting |
NCT06422884 -
A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial)
|
Phase 2 | |
| Completed |
NCT02257177 -
RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients
|
Phase 1/Phase 2 | |
| Completed |
NCT02268981 -
Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)
|
N/A | |
| Withdrawn |
NCT01524068 -
A MultiCenter Study of Combined PEX, Rituximab, and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations
|
Phase 2 | |
| Enrolling by invitation |
NCT01382368 -
Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients
|
Phase 4 | |
| Completed |
NCT01110694 -
Prospective Observation of Fibrosis in the Lung Clinical Endpoints Study
|
||
| Completed |
NCT01199887 -
Trial Of IW001 in Patients With Idiopathic Pulmonary Fibrosis
|
Phase 1 | |
| Active, not recruiting |
NCT02951416 -
Clinical Course of Interstitial Lung Diseases: European IPF Registry and Biobank
|
||
| Terminated |
NCT00981747 -
Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis
|
Phase 2/Phase 3 |