A Study to Evaluate the Efficacy and Safety of GSK3915393 in Participants With Idiopathic Pulmonary Fibrosis (IPF)

March 11, 2026 updated by: GlaxoSmithKline

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)

Idiopathic Pulmonary Fibrosis is a chronic lung disease which causes scarring of the lungs and difficulty in breathing. GSK3915393 is a new medicine, which is being tested in participants with IPF for the first time. The study will assess the safety and effectiveness of GSK3915393 in IPF participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
158

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ABP
        • GSK Investigational Site
      • Ciudad Autonoma de Bueno, Argentina, C1207AAP
        • GSK Investigational Site
      • Florida, Argentina, B1602DQD
        • GSK Investigational Site
      • La Plata, Argentina, 1900
        • GSK Investigational Site
      • Mendoza, Argentina, M5500CCG
        • GSK Investigational Site
      • Rosario, Argentina, S2000DBS
        • GSK Investigational Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • GSK Investigational Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • GSK Investigational Site
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • GSK Investigational Site
      • Hamilton, Ontario, Canada, L8N 4A6
        • GSK Investigational Site
    • Quebec
      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • GSK Investigational Site
  • France
      • La Tronche, France, 38700
        • GSK Investigational Site
      • Paris, France, 75018
        • GSK Investigational Site
      • Pessac, France, 33604
        • GSK Investigational Site
      • Rennes, France, 35000
        • GSK Investigational Site
      • Rouen, France, 76000
        • GSK Investigational Site
      • Toulouse, France, 31059
        • GSK Investigational Site
  • Germany
      • Essen, Germany, 45293
        • GSK Investigational Site
      • Hanover, Germany, 30173
        • GSK Investigational Site
      • Heidelberg, Germany, 69126
        • GSK Investigational Site
      • Wuppertal, Germany, 42283
        • GSK Investigational Site
  • Italy
      • Catania, Italy, 95123
        • GSK Investigational Site
      • Monza MB, Italy, 20900
        • GSK Investigational Site
      • Napoli, Italy
        • GSK Investigational Site
      • Padua, Italy, 35128
        • GSK Investigational Site
      • Perugia, Italy, 06132
        • GSK Investigational Site
      • Pisa, Italy, 56124
        • GSK Investigational Site
      • Roma, Italy, 00168
        • GSK Investigational Site
      • Sassari, Italy, 07100
        • GSK Investigational Site
      • Torrette AN, Italy
        • GSK Investigational Site
  • Netherlands
      • Eindhoven, Netherlands, 5623 EJ
        • GSK Investigational Site
      • Rotterdam, Netherlands, 3015 CE
        • GSK Investigational Site
  • Poland
      • Bialystok, Poland, 15-044
        • GSK Investigational Site
      • Lodz, Poland, 90-153
        • GSK Investigational Site
      • Poznan, Poland, 60-569
        • GSK Investigational Site
  • Spain
      • Barcelona, Spain
        • GSK Investigational Site
      • Barcelona, Spain, 08907
        • GSK Investigational Site
      • Madrid, Spain, 28006
        • GSK Investigational Site
      • Madrid, Spain, 28007
        • GSK Investigational Site
      • Oviedo, Spain, 33011
        • GSK Investigational Site
      • Pozuelo de AlarcOn Madr, Spain, 28223
        • GSK Investigational Site
      • Santander, Spain, 39011
        • GSK Investigational Site
      • Seville, Spain, 41013
        • GSK Investigational Site
  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SA
        • GSK Investigational Site
      • Leeds West Yorkshire, United Kingdom, LS9 7TF
        • GSK Investigational Site
      • London, United Kingdom, SW3 6HP
        • GSK Investigational Site
  • United States
    • California
      • Newport Beach, California, United States, 92663
        • GSK Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32224
        • GSK Investigational Site
      • St. Petersburg, Florida, United States, 33704
        • GSK Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5360
        • GSK Investigational Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • GSK Investigational Site
    • New York
      • New York, New York, United States, 10065
        • GSK Investigational Site
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • GSK Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37204
        • GSK Investigational Site
    • Texas
      • Cypress, Texas, United States, 77429
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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 participant choice.
  • 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/m^2) (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) greater than (>) 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 milligrams/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) 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Participants will receive placebo
Drug: Placebo
Placebo will be administered.
Experimental: GSK3915393
Participants will receive GSK3915393
Drug: GSK3915393
GSK3915393 will be administered.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Absolute Change from Baseline in Forced Vital Capacity (FVC) (milliliters [mL]) at Week 26
Time Frame: Baseline and at Week 26
Baseline and at Week 26

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Absolute Change from Baseline in Forced Vital Capacity (mL) at Weeks 4, 8, 12 and 18
Time Frame: Baseline and at Week 4, Week 8, Week 12 and Week 18
Baseline and at Week 4, Week 8, Week 12 and Week 18
Absolute Change from Baseline in Percent Predicted Forced Vital Capacity (%) at Weeks 4, 8, 12, 18 and 26
Time Frame: Baseline and at Week 4, Week 8, Week 12, Week 18 and Week 26
Baseline and at Week 4, Week 8, Week 12, Week 18 and Week 26
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to Week 26
Up to Week 26
Number of Participants with Clinically Important Findings in Electrocardiogram (ECG)
Time Frame: Baseline and up to Week 26
Baseline and up to Week 26
Number of Participants with Clinically Important Findings in Hepatobiliary Parameters
Time Frame: Baseline and up to Week 26
Baseline and up to Week 26
Number of Participants Achieving Relative Decline from Baseline in FVC (mL) Less than or Equal to (≤) 5 Percent (%) at Week 26
Time Frame: Baseline and at Week 26
Baseline and at Week 26
Number of Participants with Clinically Important Findings in Vital Signs
Time Frame: Baseline and up to Week 26
Baseline and up to Week 26
Number of Participants with Clinically Important Findings in Hematology
Time Frame: Baseline and up to Week 26
Baseline and up to Week 26
Number of Participants with Clinically Important Findings in Clinical Chemistry
Time Frame: Baseline up to Week 26
Baseline up to Week 26
Maximum observed concentration (Cmax) of GSK3915393 in IPF Participants
Time Frame: At Week 2 (pre-dose, and 0.5, 1, 1.5, 2, 3 and 4 hour post-dose)
At Week 2 (pre-dose, and 0.5, 1, 1.5, 2, 3 and 4 hour post-dose)
Area under the time-concentration curve (AUC) from Zero (pre-dose) to 4 hours post-dose sample (AUC0-4 hour) of GSK3915393
Time Frame: At Week 2 (pre-dose, and 0.5, 1, 1.5, 2, 3 and 4 hour post-dose)
At Week 2 (pre-dose, and 0.5, 1, 1.5, 2, 3 and 4 hour post-dose)
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC-inf) of GSK3915393
Time Frame: At Week 2 (pre-dose, and 0.5, 1, 1.5, 2, 3 and 4 hour post-dose)
At Week 2 (pre-dose, and 0.5, 1, 1.5, 2, 3 and 4 hour post-dose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 220929
  • 2023-509371-16-00 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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