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Trial record 1 of 3 for:    pamrevlumab | ipf
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Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

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ClinicalTrials.gov Identifier: NCT04419558
Recruitment Status : Not yet recruiting
First Posted : June 5, 2020
Last Update Posted : June 12, 2020
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 were previously treated with approved IPF therapies (i.e., nintedanib or pirfenidone; unless neither treatment is available in the host country) may be eligible for screening, provided that the subject is not currently receiving treatment with an approved IPF therapy.

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

Randomization will be stratified by GAP stage (I, II, III) derived from GAP scores obtained at screening.

Screening period: Up to 6 weeks

Treatment period: 48 weeks

Follow-up period/final assessment: 4 weeks (Week 52 [+7 Days])

The intent of this study is to evaluate the efficacy and safety profile of pamrevlumab as monotherapy in subjects with IPF who were previously treated with an approved therapy but who discontinued that therapy (possible reasons for discontinuation of approved therapy could include, but are not limited to, intolerance or disease progression), unless neither treatment is available in the host country.

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, after assessment of potential risks/benefits of such combination with blinded study treatment. However, since subjects either tried and stopped treatment with an approved IPF therapy, or have no such treatment available, it is not expected that many subjects will resume treatment with an approved IPF therapy during this study.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Zephyrus II: 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 : August 2020
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : May 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. Proportion of subjects with Disease Progression, defined as absolute FVC percent predicted (FVCpp) decline of ≥10% or death, whichever occurs first [ Time Frame: Baseline to Week 52 ]

Secondary Outcome Measures :
  1. Change in FVC (L) [ Time Frame: Baseline to Week 52 ]
  2. Change in FVCpp (absolute and relative) [ Time Frame: Baseline to Week 52 ]
  3. 4.Composite of clinical outcomes: respiratory hospitalization or death or absolute FVCpp decline ≥10%, whichever occurs first [ Time Frame: Baseline to Week 52 ]
  4. Respiratory hospitalizations during study [ Time Frame: Baseline to Week 52 ]
  5. Change in Quantitative Lung Fibrosis (QLF) volume [ Time Frame: Baseline to Week 52 ]
  6. 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.

  7. Change in University of California San Diego - Shortness of Breath Questionnaire (UCSD-SOBQ) [ Time Frame: Baseline to Week 48 ]
  8. 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.

  9. All-cause mortality during study [ Time Frame: Baseline to Week 52 ]
  10. Acute IPF exacerbations during study [ Time Frame: Baseline to Week 52 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

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 ≥50% and ≤80%.
  4. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥30% and ≤90%.
  5. Previously treated with an approved IPF therapy (i.e., pirfenidone or nintedanib) but discontinued at least 1 week prior to screening, unless neither treatment is available in the host country.

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.

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): NCT04419558


Contacts
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Contact: Gustavo Lorente 650.273.2264 Zephyrus@Fibrogen.com

Sponsors and Collaborators
FibroGen
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Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT04419558    
Other Study ID Numbers: FGCL-3019-095
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020

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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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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial