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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
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (35)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
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EssenGermanyCompleted
Pneumologicum im Suedstadtforum Dres. med. Krause Schulz Hoffmann und Geldmacher
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HanoverGermanyCompleted
Thoraxklinik Heidelberg gGmbH
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HeidelbergGermanyCompleted
Lungenfachklinik Immenhausen
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ImmenhausenGermanyCompleted
Robert Bosch Gesellschaft fuer medizinische Forschung mbH
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StuttgartGermanyCompleted
Petrus-Krankenhaus
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WuppertalGermanyCompleted
Pectus Respiratory Health S.L.
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BarcelonaSpainCompleted
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainCompleted
Hospital Universitario de la Princesa
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MadridSpainCompleted
Hospital General Universitario Gregorio Marañón
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MadridSpainCompleted
Hospital Universitario Central De Asturias
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OviedoSpainCompleted
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainCompleted
Hospital Universitario Marqués de Valdecilla
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SantanderSpainCompleted
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainCompleted
University Hospital Virgen Del Rocio S.L.
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SevillaSpainCompleted
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceCompleted
Assistance Publique Hopitaux De Paris
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Paris Cedex 18FranceCompleted
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceCompleted
Centre Hospitalier Universitaire de Rennes
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RennesFranceCompleted
CHU De Rouen
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Rouen CedexFranceCompleted
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceCompleted
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyCompleted
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
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CataniaItalyCompleted
Fondazione IRCCS San Gerardo dei Tintori
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MonzaItalyCompleted
Azienda Ospedaliera dei Colli
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NaplesItalyCompleted
Azienda Ospedale Universita Padova
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PadovaItalyCompleted
Hospital Santa Maria Della Misericordia
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PerugiaItalyCompleted
Azienda Ospedaliero Universitaria Pisana
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PisaItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyCompleted
Azienda Ospedaliero-Universitaria di Sassari
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SassariItalyCompleted
Catharina Ziekenhuis Stichting
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EindhovenNetherlandsCompleted
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsCompleted
Centrum Medycyny Oddechowej Mroz sp. j.
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BialystokPolandCompleted
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
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LodzPolandCompleted
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandCompleted

This page is information, not medical advice. Discuss any trial with your doctor.