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NCT06967805PHASE2Recruiting

WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Mediar Therapeutics

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

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 study-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, nintedanib, or nerandomilast, the dose of the medication must be stable for ≥ 90 days prior to Screening with plans to maintain the same dose throughout the study. Use of any of these 3 agents in combination with each other is not permitted. * If a participant was on treatment with pirfenidone, nintedanib, or nerandomilast, 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. Participants newly diagnosed with IPF who, in the judgment of the treating physician, are considered in need of treatment with nintedanib, pirfenidone, or nerandomilast should not defer standard of care treatment and should be excluded from 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. * Female 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 highly effective methods of contraception during treatment and until 5 half-lives or 125 days after the last dose of study drug, whichever is longer. * Male participants with female partners of childbearing potential must use condoms during the treatment and until 5 half-lives or 125 days after the last dose of study drug, whichever is longer. Exclusion Criteria: * Acute exacerbation of IPF within 6 months of Screening or during the Screening Period. * Forced expiratory volume in 1 second (FEV1)/FVC ratio of \<0.7 at Screening. * Requirement for continuous supplemental oxygen. Intermittent supplemental oxygen use (e.g., during exercise or sleep) is permitted. * Expected to receive a lung transplant within the study duration. * Current active bacterial infection or use of antibiotics for suspected lung infection in the 30 days prior to Screening. * Planned surgery within the study duration. * Clinically significant pulmonary hypertension. * Use of immunosuppressive therapy (excluding corticosteroids). If previously on such agents, they should have been discontinued for at least 5 half-lives or 90 days, whichever is longer, prior to Screening. * Use of systemic corticosteroids (prednisone or equivalent) at a dose \> 10 mg once daily within 30 days of Screening. * Currently smoking or vaping. * Current known malignancy, or history of cancer, or lymphoproliferative disorder other than non-melanomatous skin cancers, within 2 years of Screening. * Current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). * Currently pregnant, breast feeding, or planning to conceive for the length of the study. * History of severe depression, psychosis, or suicidal ideation, as determined by the Investigator, within 2 years of Screening. * Any clinically significant disease or laboratory abnormality detected at Screening that might interfere with a participant's ability to complete the study, on-study evaluations, or participant safety. * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2× upper limit of normal (ULN) at Screening. * Presence of interstitial lung disease due to any cause other than IPF, clinically significant cardiovascular disease, or any other concurrent active medical condition determined by the Investigator to interfere with the participant's ability to complete the trial. * Known allergy to MTX-463 or any of its excipients, or a history of a prior allergic reaction to a monoclonal antibody therapeutic. * Any prior use of MTX-463 or other therapy targeting WISP1. * Any other concurrent experimental agent or an active part of any other clinical study, unless they have stopped taking the investigational product at least 5 half-lives or 30 days before Screening, whichever is longer.

Interventions

BIOLOGICAL

MTX-463

OTHER

Placebo

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Conditions

Idiopathic Pulmonary Fibrosis

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