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New treatment option for Idiopathic Pulmonary Fibrosis
Official title WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)
ClinicalTrials.gov ID: NCT06967805
What this study is testing
What is MTX-463?
MTX-463 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for idiopathic pulmonary fibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase 2a, Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF)
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join 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 study-related materials.
- Meet the American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Association...
- If a participant is on treatment with pirfenidone, nintedanib, or nerandomilast, the dose of the medication must be stable for ≥ 90 days prior to...
You likely can't join 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.
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Palm Springs, California, United States
- Denver, Colorado, United States
- Loxahatchee Groves, Florida, United States
- Atlanta, Georgia, United States
- Champaign, Illinois, United States
- Kansas City, Kansas, United States
- Louisville, Kentucky, United States
- Shreveport, Louisiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Greensboro, North Carolina, United States
- Oklahoma City, Oklahoma, United States
+ 45 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Los Angeles, California, United States; Newport Beach, California, United States; Palm Springs, California, United States; Denver, Colorado, United States and 59 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.