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

  • STATUS
    Recruiting
  • End date
    Jan 31, 2023
  • participants needed
    340
  • sponsor
    FibroGen
Updated on 24 May 2022
carbon monoxide
nintedanib
idiopathic pulmonary fibrosis
pirfenidone
pamrevlumab
diffusion capacity of the lung for carbon monoxide

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

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).

Subjects who are not being treated with approved IPF therapies (i.e., nintedanib or pirfenidone) may be eligible for screening. Examples of reasons subjects may not be treated with approved IPF therapies include but are not limited to:

  • Intolerant or not responsive to approved IPF therapies
  • Ineligible to receive these therapies
  • Subject voluntarily declines to receive approved IPF therapies after being fully informed of the potential benefits/risks

NOTE: No subject should discontinue an approved IPF therapy for the purpose of enrolling in this study.

Approximately 340 eligible subjects will be randomized at a 1:1 ratio to Arm A or Arm B,

respectively

Arm A: pamrevlumab, 30 mg/kg IV, Day 1 and every 3 weeks thereafter

Arm B: Matching placebo IV, Day 1 and every 3 weeks thereafter

The study consists of the following study periods:

  • Main (double blind, placebo-controlled) phase:
  • Screening period: Up to 6 weeks
  • Treatment period: 48 weeks
  • Optional, open label extension (OLE) phase of pamrevlumab:
    • Access to pamrevlumab will be available until the last subject completes 48 weeks of treatment in the OLE phase, or pamrevlumab is commercially available for the indication of IPF, or the Sponsor decides to end the OLE phase, whichever occurs first.
  • Follow-up period/final safety assessments:
  • 28 days after last dose
  • 60 days after last dose: follow-up phone call, for a final safety assessment

During the treatment period, co-administration of an approved IPF therapy (i.e., pirfenidone or nintedanib) is acceptable if clinically indicated in the Investigator's opinion, provided that the Investigator assesses the potential risks/benefits of combining approved IPF therapies with blinded study treatment.

Subjects who discontinue study treatment for any reason should be encouraged to remain in the study and be followed for all study visits and assessments.

Subjects who complete the study will be eligible for an open-label, extension with pamrevlumab.

Details
Condition Idiopathic Pulmonary Fibrosis
Treatment Placebo, Pamrevlumab
Clinical Study IdentifierNCT03955146
SponsorFibroGen
Last Modified on24 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of IPF as defined by ATS/ERS/JRS/ALAT guidelines (Raghu 2018) within the past 7 years prior to study participation
HRCT scan at Screening, with ≥10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing
FVCpp value >45% and <95%
Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥25% and ≤90% at screening (determined locally)
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

Exclusion Criteria

Previous exposure to pamrevlumab
Evidence of significant obstructive lung disease
Female subjects who are pregnant or nursing
Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the study
Interstitial lung disease other than IPF
Sustained improvement in the severity of IPF
Other types of respiratory diseases including diseases of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall
Certain medical conditions, including recent (e.g. MI/stroke, or severe chronic heart failure or pulmonary hypertension, or cancers
Acute IPF exacerbation during Screening or Randomization
Recent use of any investigational drugs or unapproved therapies, or approved or participation in any clinical trial
History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies
Clear my responses

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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