Evaluation of Efficacy and Safety of Pamrevlumab in Patients With Idiopathic Pulmonary Fibrosis

• Status: Recruiting
• Trial end date: 2023-01-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 3 trial to evaluate the efficacy and safety of 30 mg/kg intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in subjects with Idiopathic Pulmonary Fibrosis

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FibroGen

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 >45% and <95%

4. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥25% and ≤90% at screening (determined locally).

5. Not currently receiving treatment for IPF with an approved therapy (i.e., pirfenidone or nintedanib) for any reason, including prior intolerance to an approved IPF therapy.

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.