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Evaluating a new medication for idiopathic pulmonary fibrosis

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)

PHASE2 · GlaxoSmithKline · NCT06317285

This study is testing a new medication for people with idiopathic pulmonary fibrosis to see if it can improve their lung function.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years and up
SexAll
SponsorGlaxoSmithKline (industry)
Drugs / interventionsimatinib, methotrexate, cyclophosphamide, prednisone
Locations60 sites (Los Angeles, California and 59 other locations)
Trial IDNCT06317285 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of GSK3915393, a new medication, in participants diagnosed with idiopathic pulmonary fibrosis (IPF). The study involves administering GSK3915393 and a placebo to assess its impact on lung function, specifically measuring forced vital capacity. Participants must meet specific diagnostic criteria and have a confirmed diagnosis of IPF within the last five years. The trial aims to provide insights into the potential benefits of this new treatment for individuals suffering from this chronic lung disease.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with idiopathic pulmonary fibrosis within the last five years who meet specific lung function criteria.

Not a fit: Patients with advanced idiopathic pulmonary fibrosis or those not meeting the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option that improves lung function and quality of life for patients with idiopathic pulmonary fibrosis.

How similar studies have performed: Other studies have shown promise in treating idiopathic pulmonary fibrosis with novel medications, suggesting potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participants with IPF diagnosed within 5 years prior to screening based on the applicable American Thoracic Society (ATS)/ European Respiratory Society (ERS)/ Japanese Respiratory Society (JRS)/ Latin American Thoracic Society (ALAT) Guideline at the time of diagnosis.
* Centrally read chest High Resolution Computed Tomography (HRCT) obtained at screening or historical HRCT obtained within 12 months of screening that is consistent with Usual interstitial pneumonia (UIP) or probable UIP (if indeterminate HRCT finding, IPF may be confirmed locally by historical biopsy).
* FVC greater than or equal to (\>=) 45 percent (%) of predicted normal.
* Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) \>=25% of predicted normal corrected for hemoglobin (Hb).
* Prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/FVC ≥ 0.7.
* If receiving antifibrotics must be on stable dose of nintedanib or pirfenidone for at least 12 weeks prior to screening.
* If not currently receiving pirfenidone or nintedanib, participant must have stopped pirfenidone or nintedanib for at least 4 weeks prior to screening.
* Body weight ≥40 kilogram (kg) and body mass index within the range 18.5-35 kilogram per meter square (kg/m2) (inclusive).
* A female participant is eligible to participate if a woman of nonchildbearing potential (WONCBP)
* Capable of giving signed informed consent

Exclusion Criteria:

* Participants with Interstitial Lung Disease (ILD) associated with other known causes.
* Diagnosis of sarcoidosis or any systemic autoimmune disease (including but not limited to scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosus and rheumatoid arthritis).
* Acute IPF exacerbation within 6 months prior to screening and/or during the screening period (investigator-determined).
* Clinically significant non-parenchymal lung disease (e.g., asthma, chronic obstructive pulmonary disease, cavitary or pleural diseases) at screening.
* Diagnosis of severe pulmonary hypertension (investigator-determined)
* Extent of emphysema is greater than the extent of fibrosis according to reported results from the most recent HRCT.
* History of previous lung transplant or recent major surgery (investigator-determined) within 12 weeks prior to screening or planned during the trial period. Registration on a transplant waiting list is allowed.
* Clinically significant respiratory tract infection (e.g., active tuberculosis, infectious pneumonia, Corona virus disease 2019 \[COVID-19\]) requiring treatment within 4 weeks prior to and/or during the screening period.
* Cigarette smoking (including e-cigarettes) either current or within 3 months before screening.
* Current or chronic liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* Alanine transaminase (ALT), Aspartate transaminase (AST), Alkaline phosphatase (ALP) \>2x Upper Limit of Normal (ULN) and bilirubin \>1.5x ULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin less than (\<) 35% at screening).
* Clinically significant abnormalities detected on ECG of either rhythm or conduction, a Corrected QT interval (QTc) \>450 millisecond (msec) or QTc \> 480msec for participants with a bundle branch block and/or a pacemaker who are actively ventricularly pacing during the screening ECG.
* Participants with pacemakers who are not pacing at the time of the screening ECG should have a non-paced QTc \<450 msec.

Prior/Concomitant Therapy-

* Simultaneous use of pirfenidone and nintedanib at screening.
* Received systemic corticosteroids equivalent to prednisone \>10 mg/day or equivalent within 2 weeks of screening period.
* Use of any of the following therapies within 4 weeks prior to screening and during the screening period or planned during the study:
* Immunomodulatory therapies, including but not limited to azathioprine, mycophenolate mofetil, methotrexate, tacrolimus, cyclophosphamide, imatinib, Tumour Necrosis Factor -Alpha (TNF- α) inhibitors.
* Medications that are under investigation for the treatment of IPF including inhaled treprostinil and Phosphodiesterase-4 (PDE-4) inhibitors. Symptomatic cough therapies are allowed.
* Current use of systemic strong and moderate inducers or inhibitors of Cytochrome P450 3A4 (CYP3A4) (see prohibited medication section for further information) that cannot be safely discontinued or switched to an alternative agent at least 14 days before randomization.
* Current use of systemic CYP3A4 substrates that have a narrow therapeutic index that cannot be safely discontinued or switched to an alternative agent at least 14 days before randomization.

Where this trial is running

Los Angeles, California and 59 other locations

+10 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Idiopathic Pulmonary Fibrosis, GSK3915393, Efficacy, Safety, Forced vital capacity, Tolerability

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.