WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)
The WISPer study is investigating a new medicine, MTX-463, for people with Idiopathic Pulmonary Fibrosis (IPF). This is a Phase 2 study, meaning it's still in the earlier stages of testing. Participants will receive either MTX-463 or a placebo (a treatment with no active medicine) through an IV drip. Some volunteers will also be taking existing IPF medicines like pirfenidone or nintedanib. The main goal is to check the medicine's safety and how well it works. This research helps us understand if MTX-463 could be a future treatment option for IPF, aiming to improve lung health for patients.
במבט חטוף
על מה המחקר הזה?
This study, called WISPer, is for people living with a lung condition called Idiopathic Pulmonary Fibrosis, or IPF. IPF causes scarring in the lungs, making it harder to breathe over time. Researchers are trying to find new ways to help manage this condition.
The main aim of this study is to test a new medicine called MTX-463. We want to find out if MTX-463 is safe for people with IPF and if it can help improve their lung function. To do this, some volunteers will receive the new medicine, while others will receive a 'placebo' – which looks like the medicine but doesn't contain any active ingredients. This helps researchers compare the effects fairly.
Taking part in a study like this means you'd be helping doctors learn more about IPF and potentially discover new treatments. The information gathered could lead to better care for people in the future.
נקודות עיקריות
- This study is testing a new medicine (MTX-463) for Idiopathic Pulmonary Fibrosis (IPF).
- ייתכן שתקבל את התרופה החדשה או תרופת דמה (פלצבו).
- The medicine is given through an IV drip every 4 weeks for about 20 weeks.
- The total study duration is about 28 weeks.
- You can continue certain existing IPF medicines if your dose is stable.
- Your lung function and blood will be checked regularly.
מי עשוי להיות זכאי?
To join this study, you need to be at least 40 years old and have been diagnosed with Idiopathic Pulmonary Fibrosis (IPF) within the last seven years. Your diagnosis needs to meet specific medical guidelines.
If you're already taking standard IPF medicines like pirfenidone or nintedanib, your dose must have been steady for at least 90 days before the study starts, and you must plan to continue that same dose. You can't be taking both medicines at once. If you stopped taking these medicines, it needs to have been at least 30 days before the study begins, and you can't plan to restart them during the study.
Your lung function will be checked; specifically, your Forced Vital Capacity (FVC) and Diffusion Capacity of the Lung for Carbon Monoxide (DLCO) need to be above certain levels. You must also be able to understand the study, give your written permission to take part, and be able to attend all the study appointments.
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- Are you at least 40 years old?
- Do you have a diagnosis of IPF made within the last 7 years?
- Are you able to attend regular hospital or clinic visits?
- If you take pirfenidone or nintedanib, has your dose been stable for at least 3 months?
- Do you not need continuous extra oxygen?
- Are you able to read and understand information about the study?
מה כרוך בהשתתפות?
If you join the study, you'll be randomly chosen to receive either the new medicine MTX-463 or a placebo. You won't know which one you're getting, and neither will your study doctor. Both the medicine and the placebo are given as an 'IV infusion,' which means it's delivered directly into your vein.
You'll receive an infusion every four weeks for a total of five infusions, starting on 'Day 0' and ending around 'Week 16'. The study will last about 28 weeks in total. After your last infusion, you'll have an 'End of Treatment' visit after four weeks, and a final 'Safety Follow-Up' visit four weeks after that.
Throughout the study, you'll have regular check-ups where your lung function will be measured using tests like FVC and L-PF. Blood samples will also be taken at various times to check your safety, measure levels of WISP1 (proteins that can be involved in lung scarring), and see how your body handles the study medicine.
סיכונים ותועלות פוטנציאליים
Locations (59)
- WISPer Site in Birmingham, ALמיקוד מאומתבירמינגהם, ארצות הברית
- WISPer site in Phoenix, AZמיקוד מאומתפניקס, ארצות הברית
- WISPer site in Newport Beach, CAמיקוד מאומתניופורט ביץ', ארצות הברית
- WISPer Site in Palm Springs, CAמיקוד מאומתPalm Springs, United States
- WISPer Site in Denver, COמיקוד מאומתדנוור, ארצות הברית
- WISPer site in Loxahatchee, FLמיקוד מאומתLoxahatchee Groves, United States
- WISPer Site in Atlanta, GAמיקוד מאומתאטלנטה, ארצות הברית
- WISPer site in Champaign, ILמיקוד מאומתChampaign, United States
- WISPer site in Kansas City, KSמיקוד מאומתקנזס סיטי, ארצות הברית
- WISPer site in Shreveport, LAמיקוד מאומתShreveport, United States
- WISPer Site in Baltimore, MDמיקוד מאומתבולטימור, ארצות הברית
- WISPer Site in Boston, MAמיקוד מאומתבוסטון, ארצות הברית
שאלות נפוצות
What is Idiopathic Pulmonary Fibrosis (IPF)?
IPF is a serious lung disease where scar tissue builds up in your lungs, making them stiff and hard to breathe.
מהו 'פלצבו'?
A placebo is a substance that looks exactly like the study medicine but contains no active ingredients. It helps researchers compare the effects of the real medicine.
Will I have to stop my current IPF medicine?
No, if you're on pirfenidone or nintedanib and your dose is stable, you can continue taking it during this study. You cannot be on both medications at the same time.
כמה זמן יימשך המחקר אם אצטרף?
The study involves about 20 weeks of treatment and around 8 weeks of follow-up, making the total duration about 28 weeks.
What does 'IV infusion' mean?
It means the medicine will be slowly given to you through a small tube inserted into a vein, usually in your arm.
כיצד לגלות עוד
תמיד התייעץ עם רופא המשפחה או המומחה שלך לפני שתחליט להשתתף במחקר.
דיון
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