Purpose

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

Condition

Eligibility

Eligible Ages
Between 40 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Age 40 to 85 years, inclusive, at screening initiation.
  2. Diagnosis of IPF as defined by ATS/ERS/JRS/ALAT guidelines (Raghu 2018).
  3. History of IPF diagnosis within the past 5 years with onset defined as the date of the first recorded diagnosis of IPF by HRCT and/or SLB in the medical history.
  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. FVCpp value ≥50% and ≤90% at Screening.
  6. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent of predicted and corrected by Hb value ≥30% and ≤90% at Screening.
  7. Both FVC and DLCO testing must be representative of the IPF underlying disease.
  8. Not currently receiving treatment for IPF with approved or unapproved therapy.
  9. Male subjects with partners of childbearing potential and female subjects of childbearing potential (including those <1 year postmenopausal) must use double barrier contraception methods during the conduct of the study, and for 3 months after the last dose of study drug.
  10. Able to understand and sign a written informed consent form.

Exclusion Criteria

  1. Previous exposure to pamrevlumab.
  2. Evidence of significant obstructive lung disease by any of the following criteria: (1) forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio <0.70, or (2) extent of emphysema greater than the extent of fibrosis on HRCT.
  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. 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, DLCO, and/or HRCT scans of the chest.
  7. History of other types of respiratory diseases including diseases or disorders of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall that, in the opinion of the Investigator, would impact the primary protocol endpoint or otherwise preclude the subject's participation in the study.
  8. Medical conditions (e.g. MI/stroke within the past 3-6 month) or logistical challenges that in the opinion of the Investigator preclude the subject's adequate participation in the study.
  9. Poorly controlled chronic heart failure (NYHA Class 3 or above); clinical diagnosis of cor pulmonale requiring specific treatment; or severe pulmonary arterial hypertension requiring specific treatment that, in the opinion of the Investigator, would preclude the subject's participation in the study.
  10. Clinically important abnormal laboratory tests (including serum creatinine ≥1.5 x upper limit of normal [ULN], hemoglobin (Hb) <10 g/dL, white blood cells <3,000/mm3, platelets less than 100,000/mm3, serum total bilirubin >1.5 x ULN, serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 x ULN, or serum alkaline phosphatase ≥2 x ULN.
  11. Ongoing acute IPF exacerbation, or suspicion of such process by the Investigator, during Screening or Randomization.
  12. High likelihood of lung transplantation (in the opinion of the Investigator) within 6 months after Day 1.
  13. Use of any investigational drugs or unapproved therapies, for IPF or not, in the 30 days prior to screening initiation. Or use of approved IPF therapies within 5 half-lives of screening.
  14. Daily use of PDE-5 inhibitor drugs [e.g. sildenafil, tadalafil, other]. (Note: Intermittent use of one type for erectile dysfunction or severe pulmonary hypertension is allowed).
  15. Any history of malignancy likely to result in significant disability or mortality likely to require significant medical or surgical intervention within the next 2 years. This does not include minor surgical procedures for localized cancer (e.g., basal or squamous cell carcinoma of skin).
  16. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies.
  17. Any condition (other than IPF) that is likely to result in the death of the patient within the next year.
  18. The Investigator judges that the subject will be unable to fully participate in the study and complete it for any reason, including inability to comply with study procedures and treatment, addiction, or any other relevant medical or psychiatric conditions.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Pamrevlumab
  • Drug: Pamrevlumab
    Pamrevlumab: 30 mg/kg by intravenous infusion every 3 weeks for a total of 17 infusions over 48 weeks
    Other names:
    • FG-3019
Experimental
Placebo
  • Drug: Placebo
    Placebo: 30 mg/kg by intravenous infusion every 3 weeks for a total of 17 infusions over 48 weeks

Recruiting Locations

Trials Today and nearby locations

Pulmonix, LLC
Greensboro, North Carolina 27403
Contact:
Jennifer Castillo
336-323-5276
jennifer.castillo@pulmonix.com

The University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Stephanie Greer
913-588-4030
sgreer3@kumc.edu

Pulmonary Disease Specialist, PA d/b/a, PDS Research
Kissimmee, Florida 34741
Contact:
Cathy Goodwin, CCRC
407-624-4831
cgoodwin@pds-cfsc.com

More Details

NCT ID
NCT03955146
Status
Recruiting
Sponsor
FibroGen

Study Contact

Raquel Ortega
415-978-1562
rortega@Fibrogen.com

Detailed Description

This is a Phase 3, randomized, double-blind, placebo-controlled, multi-center trial to evaluate the efficacy and safety of pamrevlumab in subjects with idiopathic pulmonary fibrosis (IPF) over a 52 week period.

Subjects who are not being treated with approved therapies (e.g. nintedanib and pirfenidone) may be eligible for screening. Examples of reasons subjects may not be treated with approved therapies include:

- Intolerant or ineligible to receive therapy, as per the Principal Investigator

- Previously received therapy, but discontinued

- Subject voluntarily declines to receive approved therapies after being fully informed of the potential benefits/risks

Approximately 565 eligible subjects will be randomized at a 3:2 ratio to Arm A or Arm B, respectively:

- Arm A: pamrevlumab, 30 mg/kg IV Q3 weeks

- Arm B: Matching placebo IV Q3 weeks

Study Duration:

- Screening period: Up to 6 weeks

- Treatment period: 48 weeks

- Follow-up period/final assessment: 4 weeks (Week 52)

Subjects who complete the 52 week study may be eligible for rollover into a separate study offering open-label, extension treatment with pamrevlumab.

The following assessments will be centralized: pulmonary function tests (PFTs) and high-resolution computed tomography (HRCT).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.