NCT06317285CompletedPhase 2
Phase 2 study to evaluate the efficacy and safety of GSK3915393 in participants with Idiopathic Pulmonary Fibrosis (IPF)
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 4 Mar 2025
Brief summary (registry, in English)
The primary objective of the study is to evaluate the efficacy of GSK3915393, compared to placebo, on reducing the decline in lung volume in IPF participants.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 78 (actual)
- First submitted
- 14 Feb 2024
- Start date
- Sept 2024
- Lead sponsor
- Glaxosmithkline Research & Development Limited
- Diseases
- Idiopathic pulmonary fibrosis
- NCT number
- NCT06317285
- EU CT number
- 2023-509371-16-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 78
- 35 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Acute IPF exacerbation within 6 months prior to screening and/or during the screening period
- Clinically significant respiratory tract infection (e.g., active tuberculosis, infectious pneumonia, COVID-19) requiring treatment within 4 weeks prior to and/or during the screening period.
- History of previous lung transplant or recent major surgery within 12 weeks prior to screening or planned during the trial period.
Other illness
- Current or chronic liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones).
Other
- ILD associated with other known causes.
Who the study is looking for
- IPF diagnosed within 5 years prior to screening based on the applicable ATS/ERS/JRS/ALAT Guideline at the time of diagnosis.
- FVC ≥45% of predicted normal.
- Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin (Hb).
- If receiving antifibrotics must be on stable dose of nintedanib or pirfenidone for at least 12 weeks prior to screening.
- If not receiving approved antifibrotics (pirfenidone or nintedanib) there should be a valid reason for this, such as previous failure, contraindications, failure to meet national or regional eligibility criteria for anti-fibrotic treatment, or patient choice.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (35)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| Pneumologicum im Suedstadtforum Dres. med. Krause Schulz Hoffmann und Geldmacher Coordinator of this site? Confirm its status | Hanover | Germany | Completed |
| Thoraxklinik Heidelberg gGmbH Coordinator of this site? Confirm its status | Heidelberg | Germany | Completed |
| Lungenfachklinik Immenhausen Coordinator of this site? Confirm its status | Immenhausen | Germany | Completed |
| Robert Bosch Gesellschaft fuer medizinische Forschung mbH Coordinator of this site? Confirm its status | Stuttgart | Germany | Completed |
| Petrus-Krankenhaus Coordinator of this site? Confirm its status | Wuppertal | Germany | Completed |
| Pectus Respiratory Health S.L. Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Completed |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Completed |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Completed |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Completed |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 18 | France | Completed |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Completed |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Completed |
| CHU De Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Completed |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Completed |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Completed |
| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Coordinator of this site? Confirm its status | Catania | Italy | Completed |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Completed |
| Azienda Ospedaliera dei Colli Coordinator of this site? Confirm its status | Naples | Italy | Completed |
| Azienda Ospedale Universita Padova Coordinator of this site? Confirm its status | Padova | Italy | Completed |
| Hospital Santa Maria Della Misericordia Coordinator of this site? Confirm its status | Perugia | Italy | Completed |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Azienda Ospedaliero-Universitaria di Sassari Coordinator of this site? Confirm its status | Sassari | Italy | Completed |
| Catharina Ziekenhuis Stichting Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Completed |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Completed |
| Centrum Medycyny Oddechowej Mroz sp. j. Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.