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Trial record 2 of 4 for:    pamrevlumab | ipf

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

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ClinicalTrials.gov Identifier: NCT03955146
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : September 17, 2021
Sponsor:
Information provided by (Responsible Party):
FibroGen

Tracking Information
First Submitted Date  ICMJE May 16, 2019
First Posted Date  ICMJE May 17, 2019
Last Update Posted Date September 17, 2021
Actual Study Start Date  ICMJE June 27, 2019
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2020)
Change in FVC (L) [ Time Frame: Baseline to Week 48 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
Change in FVC (L) [ Time Frame: Baseline to Week 52 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2020)
  • Time to disease progression defined as absolute FVCpp decline of ≥10% or death, whichever occurs first. [ Time Frame: Baseline to Week 48 ]
  • Change in FVCpp (absolute and relative) [ Time Frame: Baseline to Week 48 ]
  • Time to composite of clinical outcomes: respiratory hospitalization or death or absolute FVCpp decline ≥10%, whichever occurs first [ Time Frame: Baseline to Week 48 ]
  • Time to first respiratory hospitalizations during study [ Time Frame: Baseline to Week 48 ]
  • Change in Quantitative Lung Fibrosis (QLF) volume [ Time Frame: Baseline to Week 48 ]
  • Change in St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: Baseline to Week 48 ]
    The 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.
  • Change in University of California San Diego - Shortness of Breath Questionnaire (UCSD-SOBQ) [ Time Frame: Baseline to Week 48 ]
    The 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).
  • Change in Leicester Cough Questionnaire (LCQ) [ Time Frame: Baseline to Week 48 ]
    The LCQ is a self-reporting quality of life measure of chronic cough. It consists of 19 items with a 7 point likert response scale (range from 1 to 7). Each item is developed to assess symptoms during cough and impact of cough on three main domains: physical, psychological and social. Scores are calculated as a mean of each domain and the total score is calculated by adding every domain score.
  • Time to all-cause mortality during study [ Time Frame: Baseline to Week 48 ]
  • Time to first acute IPF exacerbations during study [ Time Frame: Baseline to Week 48 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
  • Change in FVC percent predicted (FVCpp) [ Time Frame: Baseline to Week 52 ]
  • Subjects with FVCpp decline of 10% or more or death during study [ Time Frame: Baseline to Week 52 ]
  • Composite clinical outcomes including the following: respiratory hospitalization + death + acute IPF exacerbations + FVCpp decline ≥10% [ Time Frame: Baseline to Week 52 ]
  • 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.
  • Change in QLF volume [ Time Frame: Baseline to Week 52 ]
  • 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).
  • Mortality rate [ Time Frame: Baseline to Week 52 ]
  • Acute IPF exacerbations [ Time Frame: Baseline to Week 52 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Efficacy and Safety of Pamrevlumab in Patients With Idiopathic Pulmonary Fibrosis
Official Title  ICMJE A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
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
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).

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:

    o 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Pulmonary Fibrosis
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Placebo: 30 mg/kg by intravenous infusion every 3 weeks for a total of 17 infusions over 48 weeks
Study Arms  ICMJE
  • Experimental: Pamrevlumab
    Intervention: Drug: Pamrevlumab
  • Experimental: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 1, 2020)
340
Original Estimated Enrollment  ICMJE
 (submitted: May 16, 2019)
565
Estimated Study Completion Date  ICMJE January 31, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tracy Ganske (415) 978-1427 tganske@fibrogen.com
Listed Location Countries  ICMJE Argentina,   Australia,   Chile,   China,   Czechia,   France,   Germany,   Hong Kong,   Hungary,   Italy,   Korea, Republic of,   Lebanon,   Netherlands,   Peru,   Russian Federation,   Spain,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03955146
Other Study ID Numbers  ICMJE FGCL-3019-091
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party FibroGen
Study Sponsor  ICMJE FibroGen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account FibroGen
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP