WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Start Date
5/5/2025
Completion Date
8/1/2027
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)
Detailed 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, nintedanib, or nerandomilast, 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; and a final Safety Follow-Up Visit will occur at Week 28, 8 weeks after the final infusion. Assessments of FVC will occur at Screening, Baseline, and at all subsequent treatment visits up to and including Week 24. L-PF assessments will be performed at Baseline and Week 24. Participants will have blood drawn for safety assessment and to assess WISP1 levels at Baseline and every 4 weeks throughout the study. Blood will be drawn for serum PK analyses relative to the first and last doses of MTX-463.
Eligibility Criteria
Age Range: 40 years to No maximum
Interventions
MTX-463
Placebo
Conditions
Locations
WISPer Site in Birmingham, AL
Birmingham, Alabama 35233
United States
WISPer site in Phoenix, AZ
Phoenix, Arizona 85032
United States
WISPer Site in Los Angeles, CA
Los Angeles, California 90033
United States
WISPer site in Newport Beach, CA
Newport Beach, California 92663
United States
WISPer Site in Palm Springs, CA
Palm Springs, California 92203
United States
WISPer Site in Denver, CO
Denver, Colorado 80206
United States
WISPer site in Loxahatchee, FL
Loxahatchee Groves, Florida 33470
United States
WISPer Site in Atlanta, GA
Atlanta, Georgia 30322
United States
WISPer site in Champaign, IL
Champaign, Illinois 61822
United States
WISPer site in Kansas City, KS
Kansas City, Kansas 66160
United States
WISPer Site in Louisville, KY
Louisville, Kentucky 40202
United States
WISPer site in Shreveport, LA
Shreveport, Louisiana 71103
United States
WISPer Site in Baltimore, MD
Baltimore, Maryland 21224
United States
WISPer Site in Boston, MA
Boston, Massachusetts 02114
United States
WISPer Site in Ann Arbor, MI
Ann Arbor, Michigan 48209
United States
WISPer Site in Detroit, MI
Detroit, Michigan 48202
United States
WISPer site in New York, NY
New York, New York 10032
United States
WISPer Site in Durham, NC
Durham, North Carolina 27710
United States
WISPer site in Greensboro, NC
Greensboro, North Carolina 27403
United States
WISPer site in Oklahoma City, OK
Oklahoma City, Oklahoma 73104
United States
WISPer Site in Pittsburg, PA
Pittsburgh, Pennsylvania 15213
United States
WISPer Site in Charleston, SC
Charleston, South Carolina 29425
United States
WISPer Site in Nashville, TN
Nashville, Tennessee 37204
United States
WISPer site in Dallas, TX
Dallas, Texas 75204
United States
WISPer Site in Salt Lake City, UT
Salt Lake City, Utah 84103
United States
WISPer Site in Wilwaukee, WI
Milwaukee, Wisconsin 52226
United States
WISPer Site in Buenos Aires, Argentina
Buenos Aires, B1602DQD
Argentina
WISPer Site in Cordoba, Argentina
Córdoba, X5003DCE
Argentina
WISPer Site in Mendoza, Argentina
Mendoza, M5500
Argentina
WISPer Site in Rosario, Argentina
Rosario, S2000DBS
Argentina
WISPer Site in San Miguel De Tucumán, Argentina
San Miguel de Tucumán, T4000IAI
Argentina
WISPer Site in Santa Fe, Argentina
Santa Fe, S2000DBS
Argentina
WISPer Site in Santa Fe, Argentina
Santa Fe, S3000ASF
Argentina
WISPer site in Greenslopes, Australia
Greenslopes, 4120
Australia
WISPer site in Melbourne, Australia
Melbourne, 3004
Australia
WISPer site in Midland, Australia
Midland, 6056
Australia
WISPer site in Westmead, Australia
Westmead, 2145
Australia
WISPer Site in Brussels, Belgium
Brussels, 1200
Belgium
WISPer Site in Edegem, Belgium
Edegem, 2650
Belgium
WISPer Site in Belo Horizonte, Brazil
Belo Horizonte, 30110
Brazil
WISPer Site in Curitiba, Brazil
Curitiba, 80060
Brazil
WISPer Site in Passo Fundo, Brazil
Passo Fundo, 99010
Brazil
WISPer Site in Porto Alegre, Brazil
Porto Alegre, 90035
Brazil
WISPer Site in Porto Alegre, Brazil
Porto Alegre, 90410
Brazil
WISP Site in São Bernardo Do Campo, Brazil
São Bernardo do Campo, 09715
Brazil
WISPer Site in Sao Paulo, Brazil
São Paulo, 05403
Brazil
WISPer Site in Calgary, Alberta
Calgary, Alberta T2N 4Z5
Canada
WISPer site in Ajax, ON
Ajax, Ontario L1S 2J5
Canada
WISPer site in Trois-Rivières, Quebec
Trois-Rivières, Quebec G8T 7A1
Canada
WISPer Site in Split
Split, 21000
Croatia
WISPer Site in Nantes, France
Nantes, 44800
France
WISPer Site in Nice, France
Nice, 06001
France
WISPer Site in Paris, France
Paris, 75015
France
WISPer Site in Rennes, France
Rennes, 35033
France
WISPer Site in Abbotstown, Ireland
Abbotstown, D15 X40D
Ireland
WISPer Site in Drogheda, Ireland
Drogheda, F92VW28
Ireland
WISPer Site in Dublin, Ireland
Dublin, D24 NR0A
Ireland
WISPer Site in Letterkenny, Ireland
Letterkenny, F92 AE81
Ireland
WISPer Site in Nieuwegein, Netherlands
Nieuwegein, 3435CM
Netherlands
WISPer Site in Barcelona, Spain
Barcelona, 08017
Spain
WISPer Site in Barcelona, Spain
Barcelona, 08036
Spain
WISPer Site in Lugo, Spain
Lugo, 27003
Spain
WISPer Site in Madrid, Spain 2
Madrid, 28050
Spain
WISPer Site in Madrid, Spain
Madrid, 28223
Spain
WISPer Site in Santander, Spain
Santander, 39008
Spain
WISPer Site in Birmingham, UK
Birmingham, B15 2GW
United Kingdom
WISPer Site in Cambridge, UK
Cambridge, CB2 0BB
United Kingdom
WISPer Site in Edinburgh, UK
Edinburgh, EH16 4SA
United Kingdom
WISPer Site in Oxford, UK
Oxford, OX3 7LE
United Kingdom