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.
A colpo d'occhio
Di cosa tratta questo studio?
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.
Punti chiave
- 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.
Chi può essere idoneo?
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.
Questo studio potrebbe fare al caso tuo?
Rispondi a queste domande rapide per vedere se potresti essere idoneo. Questo è solo una guida — il team di ricerca prende la decisione finale.
- 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.)
Cosa comporta la partecipazione?
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.
Rischi e benefici potenziali
Luoghi (57)
- The University of Alabama at Birmingham /ID# 277613Codice postale verificatoBirmingham, Stati Uniti· Reclutamento
- Sec Clinical Research - East - Dothan - Graceland /ID# 278328Codice postale verificatoDothan, United States· Reclutamento
- Clinical Research Specialists - Kissimmee /ID# 279184Codice postale verificatoKissimmee, United States· Reclutamento
- Christie Clinic on University /ID# 277871Codice postale verificatoChampaign, United States· Reclutamento
- University of Michigan Health System - Ann Arbor /ID# 279994Codice postale verificatoAnn Arbor, Stati Uniti· Reclutamento
- Henry Ford Hospital /ID# 277843Codice postale verificatoDetroit, Stati Uniti· Reclutamento
- Hannibal Regional Hospital /ID# 277984Codice postale verificatoHannibal, United States· Reclutamento
- Jefferson Health Honickman Center /ID# 279127Codice postale verificatoPhiladelphia, Stati Uniti· Reclutamento
- Inova Fairfax Hospital /ID# 278469Codice postale verificatoFalls Church, United States· Reclutamento
- Virginia Commonwealth University Medical Center /ID# 277992Codice postale verificatoRichmond, United States· Reclutamento
- Lung Research Queensland /ID# 278838Codice postale verificatoNundah, Australia· Reclutamento
- Eastern Health /ID# 278245Codice postale verificatoBox Hill, Australia· Reclutamento
Domande comuni
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.
Cosa significa 'doppio cieco'?
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.
What is a '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.
Per quanto tempo sarò nello studio?
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.
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