Study of ABBV-142 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Idiopathic Pulmonary Fibrosis
This research study is investigating a new medication called ABBV-142 for people with a serious lung condition known as Idiopathic Pulmonary Fibrosis (IPF). IPF causes scarring in the lungs, making it hard to breathe. The main goals are to find out if ABBV-142 is safe, if patients can tolerate any side effects, and how well it works compared to a placebo (a dummy drug). Participants will be randomly given either the new drug or the placebo for a year, and neither they nor their doctors will know which one they are taking. The study will involve about 165 adults with IPF from around the world, including the UK, and requires regular hospital visits and check-ups.
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¿De qué trata este estudio?
Idiopathic Pulmonary Fibrosis, or IPF, is a long-term lung disease that causes scarring in the lungs, making it difficult to breathe and reducing lung function over time. It can significantly impact a person's quality of life. This study is part of a larger research programme designed to test different new treatments for IPF.
Specifically, this part of the study is looking at a new medication called ABBV-142. It's an 'investigational drug', which means it's still being tested and isn't yet available as a standard treatment. The main things the researchers want to learn are if ABBV-142 is safe to use, if people can manage any side effects it might cause, and most importantly, if it actually helps to improve or manage IPF compared to a 'placebo' (a dummy treatment that looks just like the real drug but contains no active medicine).
About 165 adults with IPF will take part in this specific study worldwide. Participants will be randomly put into one of two groups: one receiving ABBV-142 and the other receiving the placebo. This process is 'double-blind', meaning neither you nor your study doctor will know which treatment you are receiving until the study is over. This helps to make sure the results are as fair and accurate as possible. The treatment period will last for about a year, followed by a period where your health continues to be monitored.
Puntos clave
- This study is testing a new drug, ABBV-142, for Idiopathic Pulmonary Fibrosis (IPF).
- It aims to check the safety, side effects, and effectiveness of the new drug compared to a dummy treatment.
- About 165 adults with IPF will take part globally, including the UK.
- You will receive either the new drug or a placebo for about a year, without knowing which one.
- Participation involves regular hospital visits, medical checks, blood tests, and questionnaires.
- You can stop participating in the study at any time.
¿Quién puede ser elegible?
To be considered for this study, you must have been diagnosed with Idiopathic Pulmonary Fibrosis (IPF) within the last seven years. Your doctor will need to confirm this diagnosis using a recent chest scan that shows the typical features of IPF.
However, there are certain reasons why you might not be able to join. For example, if you've had a stroke in the last six months, or if your doctor believes you have other significant lung problems beyond your IPF. Also, if you've had cancer in the last five years, you generally won't be able to participate, unless it was a successfully treated minor skin cancer or a very early stage cervical cancer.
The study is open to adults aged 40 and older, and welcomes both men and women.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- Have I been diagnosed with Idiopathic Pulmonary Fibrosis (IPF) in the last 7 years?
- Do I have a recent chest scan that confirms my IPF diagnosis?
- Am I aged 40 or over?
- Have I had a stroke in the last 6 months? (If yes, you likely can't join.)
- Have I had any other types of cancer in the last 5 years, apart from minor skin or early cervical cancer? (If yes, you likely can't join.)
¿En qué consiste la participación?
If you decide to take part in this study, you will be in it for over a year. For the first 52 weeks (about one year), you'll receive either ABBV-142 or a placebo. After this, if you're eligible and wish to continue, you might receive ABBV-142 for another year, this time knowing you are getting the active drug. After your treatment period, your health will be monitored for another 120 days (about 4 months).
Taking part will mean attending regular visits to a hospital or clinic. These visits will involve various medical checks, blood tests, and looking out for any side effects. You'll also be asked to fill out questionnaires to help the researchers understand how you're feeling and how the treatment might be affecting your daily life. It's important to know that this study might involve more hospital visits and tests than your usual care.
Riesgos y beneficios potenciales
Locations (57)
- The University of Alabama at Birmingham /ID# 277613Código postal verificadoBirmingham, United States· Reclutamiento
- Sec Clinical Research - East - Dothan - Graceland /ID# 278328Código postal verificadoDothan, Estados Unidos· Reclutamiento
- Clinical Research Specialists - Kissimmee /ID# 279184Código postal verificadoKissimmee, Estados Unidos· Reclutamiento
- Christie Clinic on University /ID# 277871Código postal verificadoChampaign, United States· Reclutamiento
- University of Michigan Health System - Ann Arbor /ID# 279994Código postal verificadoAnn Arbor, Estados Unidos· Reclutamiento
- Henry Ford Hospital /ID# 277843Código postal verificadoDetroit, Estados Unidos· Reclutamiento
- Hannibal Regional Hospital /ID# 277984Código postal verificadoHannibal, United States· Reclutamiento
- Jefferson Health Honickman Center /ID# 279127Código postal verificadoFiladelfia, Estados Unidos· Reclutamiento
- Inova Fairfax Hospital /ID# 278469Código postal verificadoFalls Church, United States· Reclutamiento
- Virginia Commonwealth University Medical Center /ID# 277992Código postal verificadoRichmond, Estados Unidos· Reclutamiento
- Lung Research Queensland /ID# 278838Código postal verificadoNundah, Australia· Reclutamiento
- Eastern Health /ID# 278245Código postal verificadoBox Hill, Australia· Reclutamiento
Preguntas comunes
What is Idiopathic Pulmonary Fibrosis (IPF)?
IPF is a serious lung condition where your lungs become scarred, making it harder and harder to breathe over time.
What does 'double-blind' mean?
It means neither you nor your study doctor will know if you are receiving the new drug or a dummy treatment (placebo) until the study is finished. This helps to keep the results fair.
¿Qué es un 'placebo'?
A placebo is a dummy treatment that looks exactly like the real medicine but doesn't contain any active drug. It helps researchers compare the effects of the new drug.
¿Cuánto tiempo estaré en el estudio?
You will receive treatment for about 52 weeks (one year), and then your health will be monitored for another 120 days (about 4 months). Some might get the active drug for a second year.
Will I have more hospital visits than usual?
Yes, taking part in the study will likely involve more frequent visits to the hospital or clinic for tests and check-ups compared to your standard care.
Cómo obtener más información
ABBVIE CALL CENTER
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
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Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.