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Clinical trial

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

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Last updated:1st Jun 2019
Identifier: NCT03955146

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) 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

Study Duration:
- 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

- Experimental:
- Experimental: Placebo

Category Value
Date last updated at source 2019-09-18
Study type(s) Interventional
Expected enrolment 565
Study start date 2019-06-01
Estimated primary completion date 2023-03-01

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