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

NCT06967805 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: MTX-463-I2012025-521278-32WISPer
• Study Type: interventional
• Target: 164
• Locations: 12 countries
• Sites: 69

Brief 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)

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

MTX-463-I201; MTX-463; IPF; Idiopathic Pulmonary Fibrosis; Adult; Fibrosis; Monoclonal Antibody; MAB; FVC; WISPer

Outcome Measures

Primary Outcomes (1)

• To assess the effect of MTX-463 on the change from Baseline in forced vital capacity (FVC)

  Change from Baseline to Week 24 in Forced Vital Capacity (FVC)

  24 Weeks

Secondary Outcomes (9)

• To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of treatment emergent adverse events

  28 Weeks

• To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of treatment related adverse events

  28 Weeks

• To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of serious treatment emergent adverse events

  28 Weeks

• To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of severe treatment emergent adverse events

  28 Weeks

• To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of treatment emergent abnormalities on clinical laboratory tests

  28 Weeks

Other Outcomes (9)

• To assess the development of antidrug antibodies (ADA) against MTX-463

  28 Weeks

• To assess the effect of MTX-463 on the change from Baseline in FVC in participants on concomitant nintedanib or pirfenidone

  24 Weeks

• To assess the effect of MTX-463 on the change from Baseline in FVC in participants not on concomitant nintedanib or pirfenidone

  24 Weeks

Study Arms (2)

MTX-463

EXPERIMENTAL

MTX-463

Biological: MTX-463

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

MTX-463 BIOLOGICAL

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.

MTX-463

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mediar Therapeutics: lead

Study Sites (69)

WISPer Site in Birmingham, AL

Birmingham, Alabama, 35233, United States

RECRUITING

WISPer site in Phoenix, AZ

Phoenix, Arizona, 85032, United States

RECRUITING

WISPer Site in Los Angeles, CA

Los Angeles, California, 90033, United States

RECRUITING

WISPer site in Newport Beach, CA

Newport Beach, California, 92663, United States

RECRUITING

WISPer Site in Palm Springs, CA

Palm Springs, California, 92203, United States

RECRUITING

WISPer Site in Denver, CO

Denver, Colorado, 80206, United States

RECRUITING

WISPer site in Loxahatchee, FL

Loxahatchee Groves, Florida, 33470, United States

RECRUITING

WISPer Site in Atlanta, GA

Atlanta, Georgia, 30322, United States

RECRUITING

WISPer site in Champaign, IL

Champaign, Illinois, 61822, United States

RECRUITING

WISPer site in Kansas City, KS

Kansas City, Kansas, 66160, United States

RECRUITING

WISPer Site in Louisville, KY

Louisville, Kentucky, 40202, United States

RECRUITING

WISPer site in Shreveport, LA

Shreveport, Louisiana, 71103, United States

RECRUITING

WISPer Site in Baltimore, MD

Baltimore, Maryland, 21224, United States

RECRUITING

WISPer Site in Boston, MA

Boston, Massachusetts, 02114, United States

RECRUITING

WISPer Site in Ann Arbor, MI

Ann Arbor, Michigan, 48209, United States

RECRUITING

WISPer Site in Detroit, MI

Detroit, Michigan, 48202, United States

RECRUITING

WISPer site in New York, NY

New York, New York, 10032, United States

RECRUITING

WISPer Site in Durham, NC

Durham, North Carolina, 27710, United States

RECRUITING

WISPer site in Greensboro, NC

Greensboro, North Carolina, 27403, United States

RECRUITING

WISPer site in Oklahoma City, OK

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

WISPer Site in Pittsburg, PA

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

WISPer Site in Charleston, SC

Charleston, South Carolina, 29425, United States

RECRUITING

WISPer Site in Nashville, TN

Nashville, Tennessee, 37204, United States

RECRUITING

WISPer site in Dallas, TX

Dallas, Texas, 75204, United States

RECRUITING

WISPer Site in Salt Lake City, UT

Salt Lake City, Utah, 84103, United States

RECRUITING

WISPer Site in Wilwaukee, WI

Milwaukee, Wisconsin, 52226, United States

RECRUITING

WISPer Site in Buenos Aires, Argentina

Buenos Aires, B1602DQD, Argentina

RECRUITING

WISPer Site in Cordoba, Argentina

Córdoba, X5003DCE, Argentina

RECRUITING

WISPer Site in Mendoza, Argentina

Mendoza, M5500, Argentina

RECRUITING

WISPer Site in Rosario, Argentina

Rosario, S2000DBS, Argentina

RECRUITING

WISPer Site in San Miguel De Tucumán, Argentina

San Miguel de Tucumán, T4000IAI, Argentina

RECRUITING

WISPer Site in Santa Fe, Argentina

Santa Fe, S2000DBS, Argentina

RECRUITING

WISPer Site in Santa Fe, Argentina

Santa Fe, S3000ASF, Argentina

RECRUITING

WISPer site in Greenslopes, Australia

Greenslopes, 4120, Australia

RECRUITING

WISPer site in Melbourne, Australia

Melbourne, 3004, Australia

RECRUITING

WISPer site in Midland, Australia

Midland, 6056, Australia

RECRUITING

WISPer site in Westmead, Australia

Westmead, 2145, Australia

RECRUITING

WISPer Site in Brussels, Belgium

Brussels, 1200, Belgium

RECRUITING

WISPer Site in Edegem, Belgium

Edegem, 2650, Belgium

RECRUITING

WISPer Site in Belo Horizonte, Brazil

Belo Horizonte, 30110, Brazil

RECRUITING

WISPer Site in Curitiba, Brazil

Curitiba, 80060, Brazil

RECRUITING

WISPer Site in Passo Fundo, Brazil

Passo Fundo, 99010, Brazil

RECRUITING

WISPer Site in Porto Alegre, Brazil

Porto Alegre, 90035, Brazil

RECRUITING

WISPer Site in Porto Alegre, Brazil

Porto Alegre, 90410, Brazil

RECRUITING

WISP Site in São Bernardo Do Campo, Brazil

São Bernardo do Campo, 09715, Brazil

RECRUITING

WISPer Site in Sao Paulo, Brazil

São Paulo, 05403, Brazil

RECRUITING

WISPer Site in Calgary, Alberta

Calgary, Alberta, T2N 4Z5, Canada

RECRUITING

WISPer site in Ajax, ON

Ajax, Ontario, L1S 2J5, Canada

RECRUITING

WISPer site in Trois-Rivières, Quebec

Trois-Rivières, Quebec, G8T 7A1, Canada

RECRUITING

WISPer Site in Split

Split, 21000, Croatia

RECRUITING

WISPer Site in Nantes, France

Nantes, 44800, France

RECRUITING

WISPer Site in Nice, France

Nice, 06001, France

RECRUITING

WISPer Site in Paris, France

Paris, 75015, France

RECRUITING

WISPer Site in Rennes, France

Rennes, 35033, France

RECRUITING

WISPer Site in Abbotstown, Ireland

Abbotstown, D15 X40D, Ireland

RECRUITING

WISPer Site in Drogheda, Ireland

Drogheda, F92VW28, Ireland

RECRUITING

WISPer Site in Dublin, Ireland

Dublin, D24 NR0A, Ireland

RECRUITING

WISPer Site in Letterkenny, Ireland

Letterkenny, F92 AE81, Ireland

RECRUITING

WISPer Site in Nieuwegein, Netherlands

Nieuwegein, 3435CM, Netherlands

RECRUITING

WISPer Site in Barcelona, Spain

Barcelona, 08017, Spain

RECRUITING

WISPer Site in Barcelona, Spain

Barcelona, 08036, Spain

RECRUITING

WISPer Site in Lugo, Spain

Lugo, 27003, Spain

RECRUITING

WISPer Site in Madrid, Spain 2

Madrid, 28050, Spain

RECRUITING

WISPer Site in Madrid, Spain

Madrid, 28223, Spain

RECRUITING

WISPer Site in Santander, Spain

Santander, 39008, Spain

RECRUITING

WISPer Site in Birmingham, UK

Birmingham, B15 2GW, United Kingdom

RECRUITING

WISPer Site in Cambridge, UK

Cambridge, CB2 0BB, United Kingdom

RECRUITING

WISPer Site in Edinburgh, UK

Edinburgh, EH16 4SA, United Kingdom

RECRUITING

WISPer Site in Oxford, UK

Oxford, OX3 7LE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Todd Astor, MD

  Mediar Therapeutics

  STUDY CHAIR

Central Study Contacts

Jeffrey Bornstein, MD

CONTACT

(617) 936-0960; Jeffrey@mediartx.com

Katherine Palu

CONTACT

(617) 936-0960

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: May 13, 2025
• Study Start: May 5, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6); NL (1); CA (3); CR (1); IE (4); US (26); GB (4); FR (4); AU (4); AR (7); BE (2); BR (7)