Evaluation of Efficacy and Safety of Pamrevlumab in Patients With Idiopathic Pulmonary Fibrosis
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|ClinicalTrials.gov Identifier: NCT03955146|
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
|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 are not being treated with approved therapies (e.g. nintedanib and pirfenidone) may be eligible for screening. Examples of reasons subjects may not be treated with approved therapies include:
- Intolerant or ineligible to receive therapy, as per the Principal Investigator
- Previously received therapy, but discontinued
- Subject voluntarily declines to receive approved therapies after being fully informed of the potential benefits/risks
Approximately 565 eligible subjects will be randomized at a 3:2 ratio to Arm A or Arm B, respectively:
- Arm A: pamrevlumab, 30 mg/kg IV Q3 weeks
- Arm B: Matching placebo IV Q3 weeks
- Screening period: Up to 6 weeks
- Treatment period: 48 weeks
- Follow-up period/final assessment: 4 weeks (Week 52)
Subjects who complete the 52 week study may be eligible for rollover into a separate study offering open-label, extension treatment with pamrevlumab.
The following assessments will be centralized: pulmonary function tests (PFTs) and high-resolution computed tomography (HRCT).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||565 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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 :||June 2019|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||March 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
- Change in FVC (L) [ Time Frame: Baseline to Week 52 ]
- 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 ]
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): NCT03955146
|Contact: Raquel Ortega||415-978-1562||rortega@Fibrogen.com|