A study to evaluate the efficacy and safety of GSK3915393 in Idiopathic Pulmonary Fibrosis (IPF)
Research type
Research Study
Full title
A Phase 2, randomized, double-blind, placebo-controlled, parallel group study (TRANSFORM) to evaluate the efficacy and safety of GSK3915393 in participants with Idiopathic Pulmonary Fibrosis (IPF)
IRAS ID
1004917
Contact name
George Kummeth
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2023-509371-16
Research summary
Idiopathic Pulmonary Fibrosis (IPF) is a lung disease in which scar tissue builds-up in the lungs and causes difficulty breathing. Patients with IPF can have high levels of a substance called TG2 (tissue transglutaminase 2) in their lungs. TG2 increases lung scarring and stiffness and may play a role in the development of IPF.
The aim of this study, sponsored by GlaxoSmithKline (GSK), is to test a new medicine for the treatment of IPF. This medicine blocks the action of TG2 and could reduce further lung scarring.
The study is randomised, which means a computer will put participants into either the treatment group or a placebo group by chance. A placebo is an inactive pill that contains no medicine. Participants are twice as likely to be in the treatment group than placebo. Neither the participant nor the investigator will know which group has been allocated. This is called double blind. In the UK about 4 participants 18 years of age or older will be recruited to this study.
Participants will attend hospital for a screening visit. This will be followed by 7 treatment clinic visits. During the treatment phase participants will take tablets by mouth. The participant may continue to take medicines prescribed by their doctor for their IPF (called antifibrotics). After the treatment phase, the participants will be followed up for another 3 weeks to check for safety. The maximum duration of participation is expected to be no greater than 35 weeks.
Participants will be required to give blood for testing, have lung function tests done, ECG to check the functioning of the heart on several occasions and complete an electronic diary each day. Participants will also have one scan carried out using x-rays which will give a more detailed picture of the lungs.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
24/LO/0273
Date of REC Opinion
3 Jun 2024
REC opinion
Further Information Favourable Opinion