Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: Nintedanib; Pirfenidone
Intervention description: Participants with IPF will receive nintedanib at the 200-300 mg/day dose up to 24 weeks.; Participants with IPF will receive pirfenidone at 1602-2403 mg/day dose up to 24 weeks.
Intervention MeSH terms: Pirfenidone; Nintedanib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This clinical study will evaluate the safety and tolerability of combination treatment of
      nintedanib and pirfenidone in participants with IPF. Eligible participants must have received
      pirfenidone for at least 16 weeks on a stable dose. Nintedanib will be added on Day 1 of the
      study as a combination treatment for IPF for 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who are on pirfenidone for at least 16 weeks and on a stable dose
             (defined as 1602-2403 mg/day) for at least 28 days at the start of Screening; the dose
             must be expected to remain in that range throughout the study

          -  Documented diagnosis of IPF, per the Investigator per using the criteria of the 2011
             American Thoracic Society / European Respiratory Society / Japanese Respiratory
             Society / Latin American Thoracic Association guidelines

          -  Participants with percent predicted forced vital capacity (FVC) more than or equal to
             (>=) 50 percent (%) and percent predicted carbon monoxide diffusing capacity (DLco)
             >=30% at Screening

          -  For women of childbearing potential: agreement to remain abstinent (refrain from
             heterosexual intercourse) or use two adequate methods of contraception, including at
             least one method with a failure rate of less than (<) 1% per year, during the
             treatment period and for at least 3 months after the final Follow-up Visit

          -  For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
             contraceptive measures and agreement to refrain from donating sperm during the
             treatment period and for at least 4 months after the final Follow-up Visit

        Exclusion Criteria:

          -  Participants with clinical evidence of active infection

          -  Participant with any new or ongoing moderate or severe adverse reaction considered by
             the Investigator to be related to pirfenidone, or an pirfenidone treatment
             interruption in the 28 days before the start of Screening

          -  Any condition that is likely to result in death in the 12 months after the start of
             Screening

          -  Lung transplantation anticipated or any planned significant surgical intervention

          -  Known hypersensitivity to the active substance or any excipient of either pirfenidone
             or nintedanib

          -  Mild (Child Pugh A), moderate (Child Pugh B), or severe (Child Pugh C) hepatic and/or
             severe renal impairment

          -  History of gastrointestinal (GI) tract perforation, unstable or deteriorating cardiac
             or pulmonary disease (other than IPF), long QT syndrome, alcohol or substance abuse in
             the 2 years before the start of screening, use of any tobacco product in the 12 weeks
             before the start of screening

          -  Bleeding risk

          -  Use of Cytochrome P450 (CYP) 1A2 (CYP1A2) inhibitors (for example, fluvoxamine,
             enoxacin) and/or use of inhibitors of P-glycoprotein (for example, ketoconazole,
             erythromycin) or CYP3A4 (for example, ketoconazole, erythromycin) or their inducers
             (for example, rifampicin, carbamazepine, phenytoin, St John's wort) in the 28 days
             before the start of Screening

          -  Pregnancy or lactation

          -  Hypersensitivity to peanuts and/or soy

          -  Use of pirfenidone and/or nintedanib in a clinical study protocol in the 28 days
             before the start of screening