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A Study to Evaluate the Efficacy and Safety of GSK3915393 in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
18 Years and Over
Gender
All
More 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.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 2
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
GlaxoSmithKline
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
GSK Clinical Trials
Principal Investigator Affiliation
GlaxoSmithKline
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Industry
Overall Status
Not yet recruiting
Countries
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Idiopathic Pulmonary Fibrosis
Arms & Interventions
Arms
Experimental: GSK3915393
Participants will receive GSK3915393
Experimental: Placebo
Participants will receive placebo.
Interventions
Drug: - GSK3915393
GSK3915393 will be administered.
Drug: - Placebo
Placebo will be administered.
Contact Information
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact: