Clinical Trials

Inclusion Criteria:

• Age of 18 years or over, at the time of signing the informed consent.
• IPF diagnosed within 5 years prior to screening based on the applicable ATS/ERS/JRS/ALAT Guideline at the time of diagnosis.
• Centrally read chest HRCT obtained at screening or historical HRCT obtained within 12 months of screening that is consistent with UIP or probable UIP (if indeterminate HRCT finding, IPF may be confirmed locally by historical biopsy).
• FVC ≥ 45% of predicted normal
• Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) ≥ 25% of predicted normal corrected for hemoglobin (Hb).
• Prebronchodilator 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, patient must have stopped pirfenidone or nintedanib for at least 4 weeks prior to screening.
• Body weight ≥ 40 kg and body mass index within the range 18.5-35 kg/m2 (inclusive).
• Male and female participants, as follows:
  • Male Participants:
    • No additional requirements.
  • Female Participants:
    •  A female participant is eligible to participate if:
      • She is a woman of nonchildbearing potential (WONCBP), as defined in Section 10.4 (Appendix 4) Contraception and Barrier Guidance.
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Exclusion Criteria:

• 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, 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).
• ALT, AST, ALP > 2x ULN and bilirubin > 1.5x ULN (isolated bilirubin > 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin < 35% at screening).
• Clinically significant abnormalities detected on ECG of either rhythm or conduction, a QTc > 450msec 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 ms.
  • Notes: 
    • The QTc is the QT interval corrected for heart rate according to Fridericia’s formula (QTcF). It is either machine-read or manually over-read.
• Participants who have:
  • current malignancy or
  • a previous malignancy up to 5 years prior to screening, except for those with a documented history of cured nonmetastatic squamous cell skin carcinoma, basal cell skin carcinoma, cervical carcinoma in situ or prostate cancer that is being managed through active surveillance.
• Participants with any uncontrolled medical conditions, other than IPF, that in the opinion of the investigator put the participant at unacceptable risk or interfere with study assessments or the integrity of the data. Other medical conditions should be stable at the time of screening and be expected to remain stable for the duration of the study. Participants with gastroesophageal reflux disease are eligible for the study.
• Estimated minimum life expectancy of less than 30 months for non-IPF related disease in the opinion of the investigator.
• Participants with hypersensitivity to any excipients in the clinical formulation of GSK3915393.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/1/2024. Questions regarding updates should be directed to the study team contact.