Phase 2 Interstitial Lung Disease Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People of any gender aged 40 or older at the time of signing the consent form who have been diagnosed with IPF (idiopathic pulmonary fibrosis).
• People who are able to understand the study and sign a written consent form in the study's language.
• People who have been diagnosed with IPF according to 2019 international respiratory society guidelines, and whose diagnosis was made within the last 7 years.
• People currently taking pirfenidone, nintedanib, or nerandomilast (common IPF medicines), provided the dose has been stable for at least 90 days before the screening visit and is expected to stay the same throughout the study — but only one of these medicines at a time, not in combination.
• People who stopped taking pirfenidone, nintedanib, or nerandomilast at least 30 days before the screening visit, with no plan to restart any of these medicines during the study.
• People whose lungs can breathe in and hold at least 45% of the expected normal air volume (FVC ≥ 45% predicted) at screening (confirm with trial site).
• People whose lungs can transfer at least 25% of the expected normal amount of gas (DLCO ≥ 25% predicted) at screening (confirm with trial site).
• People who are willing and able to attend all required study visits and complete all required procedures.
• Female participants who could potentially become pregnant must have a negative blood pregnancy test at screening.
• People who are able to have children must agree to use highly effective contraception during treatment and for at least 125 days after the last dose of the study drug (or longer, depending on the drug's duration in the body).
• Male participants with female partners who could potentially become pregnant must use condoms during treatment and for at least 125 days after the last dose of the study drug (or longer, depending on the drug's duration in the body).

Who may not be able to join:

• People who have had a sudden severe worsening of their IPF (acute exacerbation) within 6 months before screening or during the screening period.
• People whose lung function test results show a certain breathing ratio below 0.7 (FEV1/FVC ratio) at screening, which may suggest another lung condition is also present (confirm with trial site).
• People who need to use supplemental oxygen continuously — though those who use it only sometimes, such as during exercise or sleep, may still be considered.
• People who are expected to receive a lung transplant during the study period.
• People who currently have an active bacterial infection, or who have taken antibiotics for a suspected lung infection in the 30 days before screening.
• People who have planned surgery scheduled during the study period.
• People with a clinically significant condition of high blood pressure in the lungs (pulmonary hypertension).
• People currently taking immune-suppressing medicines (other than steroids), or who stopped taking them less than 90 days before screening (or less than 5 half-lives of the medicine, whichever is longer).
• People who have taken steroid medicines (such as prednisone) at a dose greater than 10 mg per day within the 30 days before screening.
• People who currently smoke or vape.
• People with a current or recent history (within 2 years) of cancer or a blood/lymph system disorder, other than certain minor skin cancers.
• People currently infected with hepatitis B, hepatitis C, or HIV.
• People who are currently pregnant, breastfeeding, or planning to become pregnant during the study.
• People who have had severe depression, psychosis, or thoughts of suicide within the last 2 years, as assessed by the study doctor.
• People with any significant illness or abnormal test result at screening that the study doctor believes could affect their safety or ability to complete the study.
• People with liver enzyme levels (AST or ALT) more than twice the upper limit of normal at screening (confirm with trial site).
• People with a lung disease caused by something other than IPF, a significant heart condition, or any other active medical condition the study doctor believes would interfere with completing the trial.
• People with a known allergy to the study drug (MTX-463) or its ingredients, or who have had a serious allergic reaction to a similar type of medicine (a monoclonal antibody) in the past.
• People who have previously taken MTX-463 or any other treatment that targets the same biological pathway (WISP1).
• People currently taking part in another clinical trial or taking another experimental medicine, unless they stopped taking the experimental medicine at least 30 days before screening (or 5 half-lives, whichever is longer).

Important: Always verify eligibility with the trial site directly before applying.