Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Idiopathic Pulmonary Fibrosis
• Age: Between 40 Year(s) - 100 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Able to understand and willing to provide informed consent and able to comply with the study procedures and restrictions
  2. Age =40 years at the time of informed consent.
  3. Diagnosed with IPF within 5 years prior to the date of informed consent.
  4. If currently receiving nintedanib, dose must have been stable for =3 months prior to randomization. If participant has previously discontinued nintedanib, there is a 6 week washout period required before screening can begin.
  5. Has a life expectancy of at least 12 months.
  6. Able to comply with the requirements of the study protocol, according to the investigator’s best judgment.
  7. Females of childbearing potential (ie, ovulating, premenopausal, and not surgically sterile) must:
     • Have a negative serum pregnancy test at screening.
     • Not be breastfeeding or lactating.
     • Agree to use a highly effective method of birth control for the duration of the study and for at least 30 days after the last dose in the study. Effective forms of birth control include barrier methods used in conjunction with a spermicidal agent (according to standard local practices), nonhormonal intrauterine devices, or permanent sterilization.
  8. Males must:
     • Agree to use a condom for at least 30 days after the last dose in the study even if vasectomized in order to prevent delivery of the drug via seminal fluid.
     • Agree to abstain from sperm donation through 30 days after administration of the last dose of IP.
     • Unless surgically sterile, males with female partners of childbearing potential must agree to use 2 methods of acceptable birth control for at least 30 days after the last dose in the study. Effective forms of birth control include barrier methods used in conjunction with a spermicidal agent (according to standard local practices), nonhormonal intrauterine devices in female partners, or permanent sterilization.

  
  

You may not be eligible for this study if the following are true:

• 1. Pregnant or breastfeeding.
  2. Known to have the following diseases at screening (in case of relevant disease suspicion of any of the below, confirmatory tests should be performed to rule out any of the following conditions):
     • Uncontrolled pulmonary hypertension, or pulmonary hypertension requiring chronic medical treatment (eg, sildenafil, bonsentan)
     • Congestive heart failure - Class III or IV
     • Diffuse panbronchiolitis
     • Pulmonary tuberculosis
     • Bronchiectasis
     • Pulmonary mycosis
     • Respiratory infection (viral pneumonia, bacterial pneumonia, mycoplasmal pneumonia, etc)
     • Drug-induced interstitial pneumonia, pneumoconiosis, hypersensitivity pneumonitis, or radiation pneumonitis
     • Collagen vascular disease, autoimmune disease, sarcoidosis, granulomatous disease, vasculitis, eosinophilic pneumonia, acute lung injury of known origin, cancerous lymphangiopathy, alveolar epithelial carcinoma, pulmonary lymphangioleiomyomatosis, alveolar proteinosis, Langerhans cell granulomatosis, pneumocystitis pneumonia, cytomegalovirus pneumonia
     • Severe hypertension (uncontrolled under treatment =160/100 mmHg at multiple occasions) within 3 months of Visit 1
     • Myocardial infarction, unstable cardiac angina, or history of thrombotic event (including stroke and transient ischemic attack) within 6 months of screening
     • History of significant/symptomatic bradycardia long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome or any of the following:
       • Known risk of prolonged QT interval or Torsades de Pointes.
       • Uncorrected hypomagnesemia or hypokalemia.
       • Systolic blood pressure >160 mmHg or <90 mmHg.
       • Bradycardia (heart rate <50 bpm at rest) by electrocardiogram (ECG) or pulse.
     • Unresolved respiratory tract infection within 2 weeks (including COVID-19 infections) or an acute exacerbation of IPF within 3 months prior to screening.
     • Planned surgery during the study.
     • Active cancer or a history of cancer with a significant risk of recurrence during the study. Note: If the cancer has been adequately treated, participants with localized carcinoma of the skin (eg, basal cell carcinoma) are eligible.
     • History of other types of respiratory diseases including diseases or disorders of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall that
     • Likely to have lung transplantation during the study.
       Note: Participant may be on a lung transplant list if the investigator anticipates the participant will be able to complete the study prior to transplant.
     • Clinically relevant and uncontrolled cardiac, hepatic, gastrointestinal (GI), renal, endocrine, metabolic, neurologic, or psychiatric disorders that may interfere with the participant’s ability to complete this study
     • Chronic liver disease, or biliary disease per the investigator's assessment. Note: Gilbert’s syndrome, asymptomatic gallstones, and nonactive hepatitis B (eg, presence of anti-hepatitis B surface antibody, without hepatitis B surface antigen, or anti-hepatitis B eantigen, or anti-hepatitis B core antibody alone) is acceptable if the participant otherwise meets entry criteria.
     • Use of any investigational drugs for any conditions in the 30 days prior to screening.
     • History or difficulty of swallowing, malabsorption, or other chronic GI disease or conditions that may hamper compliance and/or absorption of the study drug.
     • Receiving steroids (excluding topical steroids) in excess of a mean of 10 mg/day of prednisolone or its equivalent within 2 weeks prior to randomization.
     • Immunosuppressive agents (azathioprine, cyclophosphamide, penicillamine, methotrexate, cyclosporine, tacrolimus hydrate, mycophenolate mofetil, etc) within 4 weeks from randomization (not including participants who have used topical agents, etc).
     • Is unable to understand and to comply with study instructions and requirements.
     • Received pirfenidone within 3 months prior to randomization.