A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Mediar Therapeutics
Summary
A Phase 2a, Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF)
Description
Participants with IPF who meet the study's inclusion and exclusion criteria will be randomly assigned in a 1:1 ratio to receive MTX-463 or a matching placebo by intravenous (IV) infusion. Concomitant use of one of the approved IPF therapies, pifenidone or nintedanib, is permitted, and it is expected that about half the study population will be on one of those medications. Participants randomized to the MTX-463 arm of the study will receive an IV infusion every 4 weeks, beginning at Day 0 and ending at Week 20. The End of Treatment Visit will occur at Week 24, 4 weeks after the final infusion;…
Eligibility
- Age range
- 40+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants with IPF of any gender ≥ 40 years of age at time of signing the informed consent. * Able to understand the study and provide signed, written informed consent. * Able to read and understand the language of the informed consent and other trial-related materials. * Meet the American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Association (ATS/ERS/JRS/ALAT) 2019 criteria for the diagnosis of IPF; Diagnosed with IPF within 7 years of screening. * If a participant is on treatment with pirfenidone or nin…
Interventions
- BiologicalMTX-463
MTX-463 is an immunoglobin G1 (IgG1) monoclonal antibody directed against WNT-inducible signaling pathway protein 1 (WISP1). WISP1 (aka CCN-4) is a matricellular protein that appears to be upregulated locally in response to certain chronic diseases, including IPF, and malignancies.
- OtherPlacebo
Placebo
Locations (69)
- WISPer Site in Birmingham, ALBirmingham, Alabama
- WISPer site in Phoenix, AZPhoenix, Arizona
- WISPer Site in Los Angeles, CALos Angeles, California
- WISPer site in Newport Beach, CANewport Beach, California
- WISPer Site in Palm Springs, CAPalm Springs, California
- WISPer Site in Denver, CODenver, Colorado