Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of RXC007 in Idiopathic Pulmonary Fibrosis
This study is exploring a new treatment called RXC007 for a lung condition known as Idiopathic Pulmonary Fibrosis (IPF). Researchers want to understand if RXC007 is safe for patients, how much of it stays in the body over time, and if it has any effect on the disease. Participants will take RXC007, or a dummy treatment called a placebo, for 12 weeks. Some patients will also take RXC007 alongside their usual IPF medications, nintedanib or pirfenidone. The study aims to look at side effects, how the body handles the medicine, and if it helps improve markers related to IPF.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
This study is focused on a new medication called RXC007, which is being tested for people with Idiopathic Pulmonary Fibrosis (IPF). IPF is a long-term lung disease that causes scarring in the lungs, making it harder to breathe over time. The main goal of this research is to check how safe RXC007 is and how well people can tolerate it, meaning how many side effects they experience and if they can continue taking the treatment.
The researchers are giving RXC007 to participants for 12 weeks, either on its own or with other common IPF medicines (nintedanib or pirfenidone). They will be carefully watching for any side effects. They also want to understand how the body uses and processes RXC007 – for example, how much of the medicine gets into the bloodstream and how long it stays there. This helps them work out the best dose.
Finally, the study will also look at whether RXC007 has any positive effects on the body, especially in relation to IPF. They will do this by checking for certain markers in the body that can tell them more about the disease. Finding new ways to manage IPF is very important, and this study is a step in understanding if RXC007 could be a helpful treatment option.
النقاط الرئيسية
- This study is testing a new medicine, RXC007, for Idiopathic Pulmonary Fibrosis (IPF).
- It aims to check the safety, how the body handles the medicine, and if it helps with IPF.
- Participants will take the study medicine or a placebo for 12 weeks.
- Some participants will take RXC007 alongside their existing IPF medications.
- Regular health checks and lung tests will be part of the study.
- يمكنك التوقف عن المشاركة في أي وقت إذا رغبت في ذلك.
من قد يكون مؤهلاً؟
To join this study, you generally need to be between 40 and 80 years old. You must have been diagnosed with Idiopathic Pulmonary Fibrosis (IPF) within the last five years, and your diagnosis needs to be confirmed by independent expert review of your lung scans.
Your lung function will also be important. Specifically, tests like FVC and DLco need to meet certain levels. If you're already taking nintedanib or pirfenidone for IPF, that's generally fine, as long as you've been on a stable dose for at least four weeks before the study starts. If you've taken these medicines in the past but stopped, you'd need to have been off them for at least four weeks.
There are also some reasons why you might not be able to join. For example, if you have other serious lung infections, if your emphysema (another lung condition) is worse than your fibrosis, or if you need to use oxygen for more than 15 hours a day. Also, if you've had a sudden worsening of your IPF in the last six months, or have certain other medical conditions involving your connective tissues, you wouldn't be able to participate.
هل يمكن أن تناسبك هذه الدراسة؟
أجب عن هذه الأسئلة السريعة لترى ما إذا كنت مؤهلاً. هذا دليل فقط - الفريق البحثي هو الذي يتخذ القرار النهائي.
- Are you between 40 and 80 years old?
- Have you been diagnosed with IPF within the last 5 years?
- Do you have a certain level of lung function (FVC % predicted ≥50% and DLco ≥30%)?
- Are you able to take your current IPF medication (if applicable) stably?
- Have you not had a flare-up of your IPF in the last 6 months?
- Do you *not* need oxygen for more than 15 hours a day?
ماذا يتضمن المشاركة؟
If you decide to take part, you'll be given either the study medicine, RXC007, or a dummy treatment called a placebo. You'll take these twice a day for 12 weeks (about 3 months). During this time, you will have regular visits to the clinic to check your health, how you're feeling, and to perform different medical assessments such as blood tests, lung function tests, and possibly scans. These visits help the doctors understand how the medicine is affecting you and if you're experiencing any side effects. The total duration of your active participation will be around 12 weeks, plus some initial screening appointments and follow-up checks.
المخاطر والفوائد المحتملة
المواقع (31)
- Medical University of Viennaالرمز البريدي المؤكدفيينا، النمسا
- E PNE UZ Leuvenالرمز البريدي المؤكدلوفين، بلجيكا
- CHU De Liègeالرمز البريدي المؤكدلييج، بلجيكا
- Pneumologicka klinika 1.LF UK aالرمز البريدي المؤكدبراغ، التشيك
- Azienda Ospedaliero-Universitaria "Ospedali-Riuniti" di Anconaالرمز البريدي المؤكدأنكونا، إيطاليا
- Azienda Ospedaliero Universitaria Policlinico ''G.Rodolico-San Marco''الرمز البريدي المؤكدكاتانيا، إيطاليا
- Colonello D'avanzo Hospitalالرمز البريدي المؤكدFoggia, Italy
- PO Vito Fazziالرمز البريدي المؤكدليتشي، إيطاليا
- Ospedale S. Giuseppe Milanoالرمز البريدي المؤكدميلانو، إيطاليا
- Azienda Ospedaliera Universitaria of Modenaالرمز البريدي المؤكدModena, Italy
- Fondazione Policlinico Universitario A. Gemelliالرمز البريدي المؤكدروما، إيطاليا
- المستشفى الجامعي المتكامل فيروناالرمز البريدي المؤكدVerona, Italy
أسئلة شائعة
What is Idiopathic Pulmonary Fibrosis (IPF)?
IPF is a serious lung disease where scar tissue builds up in your lungs, making them stiff and gradually harder to breathe. The word 'idiopathic' means the cause is unknown.
ما هو الدواء الوهمي؟
A placebo is a dummy treatment that looks exactly like the real medicine but contains no active drug. It helps researchers compare the effects of the new medicine against doing nothing.
ماذا يعني مصطلح 'الحركية الدوائية'؟
Pharmacokinetics refers to how your body handles the medicine – how much of it gets absorbed, how it’s distributed, changed by the body, and eventually removed. It helps determine the right dose.
Will I know if I'm getting RXC007 or the placebo?
No, this is a 'blinded' study, meaning neither you nor your study doctor will know if you're receiving RXC007 or the placebo. This helps ensure the study results are as fair and accurate as possible.
كم من الوقت سأكون في الدراسة؟
You would be taking the study medicine (or placebo) for approximately 12 weeks (84 days). There will also be some appointments before and after this period for screening and follow-up.
كيفية معرفة المزيد
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
نقاش
مناقشة المجتمع
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