Evaluate the Safety and Efficacy of FG-3019 (Pamrevlumab) in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: Pamrevlumab; Placebo; Sub-Study: Pirfenidone; Sub-Study: Nintedanib
Intervention description: Solution for infusion; Solution for infusion; Pirfenidone concomitant therapy will not be provided by the Sponsor.; Nintedanib concomitant therapy will not be provided by the Sponsor.
Intervention MeSH terms: Pirfenidone; Nintedanib; Immunoglobulins; Antibodies; Immunoglobulin G; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Participants, Investigators, and study staff were blinded to treatment assignments and did not have access to the randomization codes. The high-resolution computed tomography (HRCT) readers were blinded to treatment assignments.
Enrollment: 160.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Idiopathic Pulmonary Fibrosis; IPF; Idiopathic Interstitial Pneumonia; Interstitial Lung Disease; Lung Fibrosis

Summary:

      To evaluate the safety and tolerability of pamrevlumab in participants with IPF, and the
      efficacy of pamrevlumab in slowing the loss of forced vital capacity (FVC) and the
      progression of IPF in these participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 40 to 80 years, inclusive.

          2. Diagnosis of IPF as defined by current international guidelines. Each participant must
             have 1 of the following: (1) Usual Interstitial Pneumonia (UIP) Pattern on an
             available high-resolution computed tomography (HRCT) scan; or (2) Possible UIP Pattern
             on an available HRCT scan and surgical lung biopsy within 4 years of Screening showing
             UIP Pattern.

          3. History of IPF of ≤5 years duration with onset defined as the date of the first
             diagnosis of IPF by HRCT or surgical lung biopsy.

          4. Interstitial pulmonary fibrosis defined by HRCT scan at Screening, with evidence of
             ≥10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing, within the
             whole lung, as determined by the HRCT central reader.

          5. FVC percent of predicted value ≥55% at Screening.

          6. Female participants of childbearing potential (including those <1 year postmenopausal)
             must be willing to use a medically acceptable method of contraception, for example, an
             oral contraceptive, depot progesterone, or intrauterine device. Male participants with
             female partners of childbearing potential who are not using birth control as described
             above must use a barrier method of contraception (for example, condom) if not
             surgically sterile (for example, vasectomy).

          7. For sub-study only: Receiving treatment for IPF with a stable dose of pirfenidone or
             with a stable dose of nintedanib for at least 3 months before Screening initiation and
             willing to continue treatment with pirfenidone or with nintedanib according to the
             corresponding approved label and the prescribing physician, including all listed
             safety requirements (for example, liver function tests, avoidance of sunlight and
             sunlamp exposure and wearing of sunscreen and protective clothing daily for
             pirfenidone, and smoking cessation).

        Exclusion Criteria:

          1. Women who are pregnant or nursing.

          2. Infiltrative lung disease other than IPF, including any of the other types of
             idiopathic interstitial pneumonias (Travis, 2013); lung diseases related to exposure
             to fibrogenic agents or other environmental toxins or drugs; other types of
             occupational lung diseases; granulomatous lung diseases; pulmonary vascular diseases;
             systemic diseases, including vasculitis and connective tissue diseases.

          3. HRCT scan findings at Screening are inconsistent with UIP Pattern, as determined by
             the HRCT central reader.

          4. Pathology diagnosis on surgical lung biopsy is anything other than UIP Pattern, as
             determined by the local pathologist.

          5. The Investigator judges that there has been sustained improvement in the severity of
             IPF during the 12 months prior to Screening, based on changes in FVC, diffusing
             capacity of the lung for carbon monoxide (DLCO), and/or HRCT scans of the chest.

          6. Clinically important abnormal laboratory tests.

          7. Upper or lower respiratory tract infection of any type within 4 weeks of the first
             Screening visit.

          8. Acute exacerbation of IPF within 3 months of the first Screening visit.

          9. Use of medications to treat IPF within 5 half-lives of Day 1 dosing. If monoclonal
             antibodies were used, the last dose of the antibody must be at least 4 weeks before
             Day 1 dosing. This applies to participants enrolled in Main Study only.

         10. Use of any investigational drugs, including any investigational drugs for IPF, within
             4 weeks prior to Day 1 dosing.

         11. History of cancer diagnosis of any type in the 3 years preceding Screening, excluding
             non-melanomatous skin cancer, localized bladder cancer, or in situ cancers.

         12. Diffusing capacity (DLCO) less than 30% of predicted value.

         13. History of allergic or anaphylactic reaction to human, humanized, chimeric, or murine
             monoclonal antibodies.

         14. Previous treatment with FG-3019.

         15. Body weight greater than 130 kilograms.