Phase 2 Interstitial Lung Disease Trial, Recruiting

Written by an AI model from 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 who are willing and able to sign a consent form showing they understand the study and are choosing to take part voluntarily.
• People who are aged 40 or older at the time of signing the consent form, of any gender.
• People who have been diagnosed with idiopathic pulmonary fibrosis (IPF) — a condition where the lungs become scarred for no known reason — according to 2022 international specialist guidelines.
• People whose lung scan (a type of detailed CT scan called an HRCT) shows a pattern consistent with IPF, as confirmed by an independent imaging review; the scan must have been taken within the past 12 months or during the screening period.
• People whose lungs are still able to hold at least 45% of the air they should be able to hold, as measured by a breathing test during screening.
• People whose lungs are transferring oxygen into the blood at a level between 30% and 90% of what is expected, as measured by a specific breathing test during screening.
• People who are either currently taking a stable dose of nintedanib or pirfenidone (standard IPF medications) for at least 8 weeks and plan to continue, OR people who have not taken either of these medications for at least 4 weeks and do not plan to start them during the study (note: no one should stop an approved treatment just to join this trial, and treatment-naïve patients must have a full discussion with the doctor about the risks and benefits of not taking these medications).
• People who are able to have children (male or female) and agree to use reliable contraception from the time of signing the consent form until at least 6 months after the last dose of the study drug.

Who may not be able to join:

• People whose lung scarring has a known cause, such as exposure to dust or chemicals at home or work, a connective tissue disease, or a reaction to medication.
• People who have other significant lung conditions, such as asthma, chronic obstructive pulmonary disease (COPD), or certain structural lung problems, that the doctor considers clinically important.
• People whose CT scan shows that more than 50% of their lungs are affected by emphysema (air trapping and lung tissue damage), or where emphysema is more prominent than scarring.
• People who have had a sudden, serious worsening of their IPF within the 3 months before screening or during the screening period.
• People whose IPF has shown a sustained improvement in the 12 months before screening or during the screening period, based on breathing tests and/or CT scan results.
• People whose breathing test results show a certain pattern suggesting airflow blockage (a specific ratio of two measurements falls below 0.70) (confirm with trial site).
• People whose airways open up significantly after using a bronchodilator inhaler, as shown by a breathing test (confirm with trial site).
• People who have smoked — including cigarettes, cigars, pipes, or e-cigarettes — within the 3 months before screening, or who are unable to avoid smoking for the entire duration of the study.
• People who have completed a heart and lung exercise rehabilitation programme within the 8 weeks before screening, or who plan to start one during the study.
• People who have pulmonary hypertension (high blood pressure in the lung's blood vessels) or related heart strain that the doctor believes would significantly affect their ability to participate or affect study results.
• People who have previously had lung volume reduction surgery or a lung transplant, or who plan to have either during the study (people already on a transplant waiting list may still be eligible — confirm with trial site).
• People who have had a major surgical procedure within the 4 weeks before screening or during screening, or who plan to have major surgery during the study.
• People who have a history of serious heart or stroke-related conditions, including certain irregular heartbeats, severe heart failure, very low heart pumping function, poorly controlled high blood pressure, or a heart attack, stroke, or mini-stroke within the 6 months before screening.
• People who currently have or are suspected of having cancer, or who have had cancer within the past 5 years (certain minor skin cancers and other specific cancers that have been successfully treated with no recurrence may be exceptions — confirm with trial site).
• People who have an active autoimmune disease (where the immune system attacks the body), or a history of one that may come back, such as lupus, rheumatoid arthritis, inflammatory bowel disease, or multiple sclerosis, among others.
• People who have had an active bacterial, viral, or fungal infection requiring antibiotic or antiviral treatment within the 4 weeks before screening or during the screening period.
• People who have active hepatitis B or hepatitis C infection, as confirmed by specific blood tests.
• People with a known immune deficiency, including those who test positive for HIV.
• People who test positive for tuberculosis (TB) during screening, unless they have already completed treatment for TB within the past 6 months with no signs of it returning.
• People whose blood tests during screening show that the liver is not functioning within acceptable limits, or that kidney function is below a certain level (confirm specific values with trial site).
• People who have previously been treated with certain specific drugs that target a protein called CSF-1R (other than nintedanib), or with antibody-based treatments targeting the same pathway.
• People who have a known allergy or sensitivity to the ingredients of the study drug, or who have had a serious reaction to antibody-based treatments in the past.
• People who have taken another experimental drug within 4 weeks before screening, or within 5 times the drug's half-life, whichever is longer (confirm with trial site).
• People who have taken other newly approved anti-scarring medications (other than nintedanib or pirfenidone) within the 4 weeks before screening or during screening, or who plan to take them during the study.
• People who have been taking both nintedanib and pirfenidone together within the 8 weeks before screening or during the screening period.
• People who have taken certain immune-suppressing or cell-affecting medications (such as methotrexate, azathioprine, or similar drugs) within the 4 weeks before screening or during the screening period.
• People who have been taking high-dose steroid tablets (above a certain daily dose) within the 4 weeks before screening or during the screening period.
• People taking nintedanib who are currently using or plan to use certain medications that interact with it in a way that could affect how the body processes the drug (confirm specific medications with trial site).
• People taking pirfenidone who are currently using or plan to use certain medications that affect how the body processes pirfenidone (confirm specific medications with trial site).
• People who are unable to avoid using certain types of bronchodilator inhalers in the hours before scheduled breathing tests during the study.
• People with a known or suspected history of alcohol or drug misuse within the 2 years before screening or during the screening period.
• People who are pregnant or breastfeeding, or women of childbearing potential who test positive on a pregnancy test within 7 days before the first dose of the study drug.
• People with any other medical condition, treatment, or test result that, in the doctor's judgement, could affect their ability to safely participate, increase their risk of harm, affect the reliability of study results, or make participation not in their best interest.

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