Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04419558|
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : November 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Pulmonary Fibrosis||Drug: Pamrevlumab Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||340 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 2023|
|Estimated Study Completion Date :||May 2023|
Pamrevlumab: 30 mg/kg by intravenous infusion every 3 weeks for a total of 17 infusions over 48 weeks
Other Name: FG-3019
Placebo: 30 mg/kg by intravenous infusion every 3 weeks for a total of 17 infusions over 48 weeks
- 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 ]
- Change in FVC (L) [ Time Frame: Baseline to Week 52 ]
- Change in FVCpp (absolute and relative) [ Time Frame: Baseline to Week 52 ]
- 4.Composite of clinical outcomes: respiratory hospitalization or death or absolute FVCpp decline ≥10%, whichever occurs first [ Time Frame: Baseline to Week 52 ]
- Respiratory hospitalizations during study [ Time Frame: Baseline to Week 52 ]
- Change in Quantitative Lung Fibrosis (QLF) volume [ Time Frame: Baseline to Week 52 ]
- 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 ]
- 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.
- All-cause mortality during study [ Time Frame: Baseline to Week 52 ]
- Acute IPF exacerbations during study [ Time Frame: Baseline to Week 52 ]
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: Gustavo Lorente||650.273.2264||Zephyrus@Fibrogen.com|
|Budapest, Hungary, 1121|
|Törökbálint, Hungary, 2045|
|Forli, Italy, 47121|
|Rome, Italy, 00168|
|Research Center||Not yet recruiting|
|Beirut, Lebanon, 166830|
|Research Center||Not yet recruiting|
|Bir Hassan, Lebanon, 28337401|