Clinical trial: Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF) (NCT04419558)

Eligibility criteria:
Key Inclusion Criteria:

          1. Diagnosis of IPF as defined by ATS/ERS/JRS/ALAT guidelines (Raghu 2018) within the
             past 7 years prior to study participation.

          2. HRCT scan at Screening, with ≥10% to <50% parenchymal fibrosis (reticulation) and <25%
             honeycombing.

          3. FVCpp value ≥50% and ≤80%.

          4. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥30% and
             ≤90%.

          5. Previously treated with an approved IPF therapy (i.e., pirfenidone or nintedanib) but
             discontinued at least 1 week prior to screening, unless neither treatment is available
             in the host country.

        Key Exclusion Criteria:

          1. Previous exposure to pamrevlumab.

          2. Evidence of significant obstructive lung disease.

          3. Female subjects who are pregnant or nursing.

          4. Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the
             study.

          5. Interstitial lung disease other than IPF.

          6. Sustained improvement in the severity of IPF.

          7. Other types of respiratory diseases including diseases of the airways, lung
             parenchyma, pleural space, mediastinum, diaphragm, or chest wall.

          8. Certain medical conditions, including recent (e.g. MI/stroke, or severe chronic heart
             failure or pulmonary hypertension, or cancers.

          9. Acute IPF exacerbation during Screening or Randomization.

         10. Recent use of any investigational drugs or unapproved therapies, or approved or
             participation in any clinical trial.

         11. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine
             monoclonal antibodies.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea.  Other medical conditions include hypertension and osteoarthritis.  The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs.  He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs.  Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled  pulmonary fibrosis that is most predominant in the lower lobes, characterized  by the presence of asbestos bodies (golden-brown beaded rods with translucent centers).

Patient description (patient's own words): I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there.

Does the patient match the trial criteria? Entailment