Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
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|ClinicalTrials.gov Identifier: NCT04419558|
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : July 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Pulmonary Fibrosis||Drug: Pamrevlumab Drug: Placebo||Phase 3|
The intent of this study is to evaluate the efficacy and safety profile of pamrevlumab as monotherapy in participants 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 48-week treatment phase of the study, co-administration of an approved IPF therapy (such as, 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 participants either tried and stopped treatment with an approved IPF therapy, or have no such treatment available, it is not expected that many participants will resume treatment with an approved IPF therapy during this study.
Participants who complete the 48-week study will be eligible for an optional, open-label extension phase with continued access to pamrevlumab, regardless of their randomized assignment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||340 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||During the Open-label extension phase, all participants will receive pamrevlumab in an open-label manner. No unblinding of participant's treatment assignment in the treatment phase (main study) will occur for purposes of open-label extension participation.|
|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)|
|Actual Study Start Date :||September 30, 2020|
|Estimated Primary Completion Date :||April 30, 2023|
|Estimated Study Completion Date :||May 31, 2023|
Treatment phase: Pamrevlumab 30 mg/kg administered by intravenous infusion, every 3 weeks, for a total of 17 infusions over 48 weeks.
Open-label extension phase: Pamrevlumab 30 mg/kg administered by intravenous infusion, every 3 weeks for up to 48 weeks
Sterile solution for injection
Other Name: FG-3019
Pamrevlumab-matching placebo administered by intravenous infusion every 3 weeks for a total of 17 infusions over 48 weeks
Sterile solution for injection
- Time to Disease Progression [ Time Frame: Up to Week 48 ]Defined as absolute forced vital capacity (FVC) percent predicted (FVCpp) decline of ≥10% or death, whichever occurs first
- Change from Baseline to Week 48 in FVC [ Time Frame: Baseline, Week 48 ]
- Change from Baseline to Week 48 in Absolute and Relative FVCpp [ Time Frame: Baseline, Week 48 ]
- Time to Composite of Clinical Outcomes: Respiratory Hospitalization or Death or Absolute FVCpp Decline ≥10%, Whichever Occurs First [ Time Frame: Up to Week 48 ]
- Time to First Respiratory Hospitalization [ Time Frame: Up to Week 48 ]
- Change from Baseline to Week 48 in Quantitative Lung Fibrosis (QLF) Volume [ Time Frame: Baseline, Week 48 ]
- Change from Baseline to Week 48 in St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: Baseline, Week 48 ]The SGRQ is a 50-item questionnaire developed to measure health status (quality of life). Scores are calculated for 3 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 from Baseline to Week 48 in University of California San Diego - Shortness of Breath Questionnaire (UCSD-SOBQ) [ Time Frame: Baseline, Week 48 ]
- Change from Baseline to Week 48 in Leicester Cough Questionnaire (LCQ) [ Time Frame: Baseline, 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 (ranging from 1 to 7). Each item is developed to assess symptoms during cough and impact of cough on 3 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 [ Time Frame: Up to Week 48 ]
- Time to First Acute IPF Exacerbation [ Time Frame: Up to Week 48 ]
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
|Contact: Director of Clinical Operations, FibroGen||650.273.2264||Zephyrus@Fibrogen.com|