A blinded, randomised and placebo-controlled study in patients with idiopathic pulmonary fibrosis
Research type
Research Study
Full title
A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis
IRAS ID
1004758
Contact name
Michael Lamm
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2021-005066-17
Research summary
This is a Phase II study involving 94 patients aged at least 40 years who have a diagnosis of Idiopathic Pulmonary Sarcoidosis, a chronic, progressive disease for which currently there is an unmet clinical need. It uses a platform design which allows several investigational drugs to be tested in an adaptive way under the same conditions in one study. This study is the first cohort of potentially more and the aim of the study is to see whether the study drug improves lung function in the target patient population. The study will take place in secondary care sites as this is where these patients are usually cared for. The PI or a delegated member of the study team will approach potential patients to gauge their interest in the study. Should a patient be interested in taking part they will provided with a Patient Information Sheet and invited to attend the site for a screening visit. If they do decide to take part in the study, they will sign the consent form before undergoing a variety of assessments including but not limited to: blood sampling, ECG, lung function assessment, CT scan of chest, TB testing, 6 minute walking test and questionnaires. There will be one cohort 1 used to assess the safety and efficacy of LTP001, an oral compound, in participants with mild to moderate IPF. The cohort will have two arms:
Arm 1: LTL001 6mg o.d p.o
Arm 2: matching placebo
Both investigator and patient will be blinded to the study treatment, although the investigator will be able to find out what treatment any patient is receiving if required. After a screening and run-in period of up to 43 days, patients will be randomised to receive treatment/placebo for up to 26 weeks before entering a follow up phase of approximately 30 days.REC name
London - Harrow Research Ethics Committee
REC reference
23/LO/0223
Date of REC Opinion
5 Sep 2023
REC opinion
Further Information Favourable Opinion