A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Status: Recruiting
Location: See all (44) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 2
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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 nintedanib, the dose of the medication must be stable for ≥ 90 days prior to Screening with plans to maintain the same dose throughout the study treatment period. Use of both agents together is not permitted.

• If a participant was on treatment with nintedanib or pirfenidone, and the agent has been discontinued, this must have occurred ≥ 30 days prior to Screening. At Screening, there must also be no plan to start either of these medications for the duration of the study.

• FVC of ≥ 45 percent predicted (pp) at screening.

• DLCO of ≥ 25pp at screening.

• Willing and able to complete all protocol required study visits and procedures.

• All participants of childbearing potential must have a negative serum pregnancy test at Screening.

• Participants with reproductive potential must agree to use and follow medically approved contraceptive precautions during the study

Locations
United States
Alabama
WISPer Site in Birmingham, AL
RECRUITING
Birmingham
Arizona
WISPer site in Phoenix, AZ
RECRUITING
Phoenix
California
WISPer Site in Los Angeles, CA
RECRUITING
Los Angeles
WISPer site in Newport Beach, CA
RECRUITING
Newport Beach
WISPer Site in Palm Springs, CA
RECRUITING
Palm Springs
Colorado
WISPer Site in Denver, CO
RECRUITING
Denver
Florida
WISPer site in Loxahatchee, FL
RECRUITING
Loxahatchee Groves
Illinois
WISPer site in Champaign, IL
RECRUITING
Champaign
Kansas
WISPer site in Kansas City, KS
RECRUITING
Kansas City
Louisiana
WISPer site in Shreveport, LA
RECRUITING
Shreveport
Maryland
WISPer Site in Baltimore, MD
RECRUITING
Baltimore
Michigan
WISPer Site in Ann Arbor, MI
RECRUITING
Ann Arbor
WISPer Site in Detroit, MI
RECRUITING
Detroit
North Carolina
WISPer Site in Durham, NC
RECRUITING
Durham
WISPer site in Greensboro, NC
RECRUITING
Greensboro
New York
WISPer site in New York, NY
RECRUITING
New York
Oklahoma
WISPer site in Oklahoma City, OK
RECRUITING
Oklahoma City
South Carolina
WISPer Site in Charleston, SC
RECRUITING
Charleston
Tennessee
WISPer Site in Nashville, TN
RECRUITING
Nashville
Texas
WISPer site in Dallas, TX
RECRUITING
Dallas
Utah
WISPer Site in Salt Lake City, UT
RECRUITING
Salt Lake City
Wisconsin
WISPer Site in Wilwaukee, WI
RECRUITING
Milwaukee
Other Locations
Australia
WISPer site in Greenslopes, Australia
RECRUITING
Greenslopes
WISPer site in Melbourne, Australia
RECRUITING
Melbourne
WISPer site in Midland, Australia
RECRUITING
Midland
WISPer site in Westmead, Australia
RECRUITING
Westmead
Belgium
WISPer Site in Brussels, Belgium
RECRUITING
Brussels
Brazil
WISPer Site in Belo Horizonte, Brazil
RECRUITING
Belo Horizonte
Canada
WISPer site in Ajax, ON
RECRUITING
Ajax
WISPer Site in Calgary, Alberta
RECRUITING
Calgary
WISPer site in Trois-Rivières, Quebec
RECRUITING
Trois-rivières
Croatia
WISPer Site in Split
RECRUITING
Split
France
WISPer Site in Nice, France
RECRUITING
Nice
WISPer Site in Paris, France
RECRUITING
Paris
WISPer Site in Rennes, France
RECRUITING
Rennes
Ireland
WISPer Site in Drogheda, Ireland
RECRUITING
Drogheda
WISPer Site in Dublin, Ireland
RECRUITING
Dublin
WISPer Site in Letterkenny, Ireland
RECRUITING
Letterkenny
Spain
WISPer Site in Barcelona, Spain
RECRUITING
Barcelona
WISPer Site in Madrid, Spain
RECRUITING
Madrid
United Kingdom
WISPer Site in Birmingham, UK
RECRUITING
Birmingham
WISPer Site in Cambridge, UK
RECRUITING
Cambridge
WISPer Site in Edinburgh, UK
RECRUITING
Edinburgh
WISPer Site in Oxford, UK
RECRUITING
Oxford
Contact Information
Primary
Jeffrey Bornstein, MD
Jeffrey@mediartx.com
(617) 936-0960
Backup
Katherine Palu
(617) 936-0960
Time Frame
Start Date: 2025-05-05
Estimated Completion Date: 2027-08
Participants
Target number of participants: 164
Treatments
Experimental: MTX-463
MTX-463
Placebo_comparator: Placebo
Placebo
Sponsors
Leads: Mediar Therapeutics

This content was sourced from clinicaltrials.gov