Study to Evaluate the Efficacy, Safety, and Tolerability of Axatilimab in Subjects with IPF
Research type
Research Study
Full title
A 26-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Axatilimab in Subjects with Idiopathic Pulmonary Fibrosis (IPF)
IRAS ID
1006183
Contact name
Pramila Monte
Contact email
Sponsor organisation
Syndax Pharmaceuticals, Inc.
Eudract number
2022-502954-15
Clinicaltrials.gov Identifier
Research summary
This is a Phase 2b, randomised, double-blind, placebo-controlled, multi-centre study to evaluate the efficacy, safety, and tolerability of axatilimab through Week 26 in participants with Idiopathic Pulmonar Fibrosis (IPF).
Axatilimab is a “monoclonal antibody”, which is an antibody manufactured in a laboratory. It is designed to specifically block a protein believed to be involved in lung fibrosis. By blocking this protein, axatilimab may slow or halt the progression of IPF.
To date, a total of 333 participants have received at least one dose of axatilimab, which included 14 healthy participants, 45 participants with solid tumours, and 274 participants with chronic graft-versus-host disease (cGVHD). This will be the first time that axatilimab will be given to participants with IPF.
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Axatilimab when given intravenously (through a vein) to male and female participants with IPF.
The study will also look at how the study drug behaves inside the body and how it leaves the body. This is called the pharmacokinetics of the study drug. For this reason, blood samples will be collected to measure the pharmacokinetics of the study drug within the body.
Approximately 135 participants will participate in this study at approximately 70 study sites worldwide. Participation in this study will last up to 36 weeks and will include approximately 19 visits to the study site. This includes a 10-week follow-up period that includes a 14-day follow-up phone call, and an anti-drug antibody (ADA) follow-up visit 10 weeks after participants final study visit.
All sites in the UK for this study will be based in hospitals.
REC name
London - Brent Research Ethics Committee
REC reference
24/LO/0051
Date of REC Opinion
7 Mar 2024
REC opinion
Further Information Favourable Opinion