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

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ClinicalTrials.gov Identifier: NCT03955146
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
FibroGen

Brief 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

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: Pamrevlumab Drug: Placebo Phase 3

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 565 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023


Arm Intervention/treatment
Experimental: Pamrevlumab Drug: Pamrevlumab
Pamrevlumab: 30 mg/kg by intravenous infusion every 3 weeks for a total of 17 infusions over 48 weeks
Other Name: 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




Primary Outcome Measures :
  1. Change in FVC (L) [ Time Frame: Baseline to Week 52 ]

Secondary Outcome Measures :
  1. Change in FVC percent predicted (FVCpp) [ Time Frame: Baseline to Week 52 ]
  2. Subjects with FVCpp decline of 10% or more or death during study [ Time Frame: Baseline to Week 52 ]
  3. Composite clinical outcomes including the following: respiratory hospitalization + death + acute IPF exacerbations + FVCpp decline ≥10% [ Time Frame: Baseline to Week 52 ]
  4. Change in St. George's Respiratory Questionnaire (SGRQ) score [ Time Frame: Baseline to Week 52 ]
    The St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire developed to measure health status (quality of life). Scores are calculated for three domains: Symptoms, Activity and Impacts. The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status.

  5. Change in QLF volume [ Time Frame: Baseline to Week 52 ]
  6. Change in University of California San Diego - Shortness of Breath Questionnaire (UCSD-SOBQ) [ Time Frame: Baseline to Week 52 ]
    The University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) is a 24-item questionnaire developed to measure breathlessness associated with activities of daily living, on a scale between zero and five where 0 is not at all breathless and 5 is maximally breathless or too breathless to do the activity. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome).

  7. Mortality rate [ Time Frame: Baseline to Week 52 ]
  8. Acute IPF exacerbations [ Time Frame: Baseline to Week 52 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955146


Contacts
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Contact: Raquel Ortega 415-978-1562 rortega@Fibrogen.com

Sponsors and Collaborators
FibroGen

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Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT03955146     History of Changes
Other Study ID Numbers: FGCL-3019-091
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by FibroGen:
Idiopathic Pulmonary Fibrosis, IPF, Idiopathic Interstitial Pneumonia, Interstitial Lung Disease, Lung Fibrosis

Additional relevant MeSH terms:
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Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial