A Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa
This study is investigating a new medicine called Bimekizumab for younger people, specifically children and teenagers aged 9 to 17, who have hidradenitis suppurativa (HS). HS is a chronic skin condition causing painful bumps and boils. Researchers want to understand how Bimekizumab moves through the body of these young patients and how safe it is for them. This is a late-stage study, meaning the medicine has already been through earlier testing. The aim is to see if Bimekizumab could be a new treatment option for young people living with moderate to severe HS.
במבט חטוף
על מה המחקר הזה?
This study is designed to explore a new medicine called Bimekizumab for children and teenagers who have a skin condition called Hidradenitis Suppurativa (HS). HS causes painful lumps, boils, and sometimes tunnels under the skin, often in areas like the armpits or groin. It can be quite severe, and current treatments don't always work for everyone, especially younger patients.
The main goals of this study are twofold. Firstly, researchers want to understand how Bimekizumab behaves in the bodies of young people – how much medicine gets into the bloodstream, how long it stays there, and how it's handled by the body. This is important to ensure the right dose is given. Secondly, they want to check the safety of Bimekizumab for this age group. They will carefully monitor participants for any side effects or unwanted reactions.
By gathering this information, the study aims to see if Bimekizumab could become a safe and effective new treatment option for young people aged 9 to 17 living with moderate to severe HS. It's a phase 3 study, which means it’s a later stage of research, often done before a medicine can be considered for wider use.
נקודות עיקריות
- This study investigates a new medicine (Bimekizumab) for moderate to severe HS.
- It's for children and teenagers aged 9-17.
- The study will check how safe the medicine is and how it works in the body.
- It's a Phase 3 study, meaning it's a late-stage test.
- Participation involves regular clinic visits and close monitoring.
- אתה יכול לפרוש מהמחקר בכל עת.
מי עשוי להיות זכאי?
This study is looking for young people aged 9 to 17 years old who have Hidradenitis Suppurativa (HS). To be considered, you must have been diagnosed with HS for at least six months and have moderate to severe HS with at least five inflamed bumps (abscesses or painful lumps). Your HS should affect at least two different body areas, with at least one area being moderately or severely affected (known as Hurley Stage II or III). You also need to weigh at least 30 kilograms (about 4 stone 10 pounds) and have tried a course of antibiotics for your HS that didn't work well enough.
There are also some reasons why you might not be able to join. For example, if you have more than 20 draining tunnels from your HS, or if you've already tried certain biologic medicines (like brodalumab, ixekizumab, or secukinumab) for HS and they didn't help at all. You also can't join if you've been in this study before or have taken Bimekizumab previously. Other reasons include a history of certain bowel conditions (like Inflammatory Bowel Disease), active or untreated tuberculosis, or ongoing serious infections.
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 between 9 and 17 years old?
- Have you been diagnosed with HS for at least 6 months?
- Do you have moderate to severe HS affecting at least two body areas?
- Does your HS include at least 5 active bumps (abscesses or inflamed lumps)?
- Have you tried antibiotics for your HS that didn't work well enough?
- Do you weigh at least 30 kilograms (around 4 stone 10 pounds)?
מה כרוך בהשתתפות?
If you decide to take part in this study, you will receive doses of Bimekizumab, likely given as an injection under the skin. You will have regular visits to the clinic where the study team will monitor your health, assess your HS, and check for any side effects. This will involve physical examinations, blood tests, and potentially other procedures to see how the medicine is working and how you are feeling. The study will involve a number of visits over a period that isn't fully detailed here, but will be explained to you by the study team. You'll need to follow specific instructions about other medicines you might be taking. The study team will provide all the necessary medication and care related to the trial.
סיכונים ותועלות פוטנציאליים
מיקומים (18)
- Hs0006 50175מיקוד מאומתפניקס, ארצות הברית· גיוס
- Hs0006 50708מיקוד מאומתRoseville, United States· גיוס
- Hs0006 50684מיקוד מאומתסקרמנטו, ארצות הברית· פעיל אך לא מגייס
- Hs0006 50707מיקוד מאומתוושינגטון די.סי., ארצות הברית· גיוס
- Hs0006 50199מיקוד מאומתמיאמי, ארצות הברית· גיוס
- Hs0006 50178מיקוד מאומתClarkston, United States· גיוס
- Hs0006 50710עיר בלבדFort Gratiot, United States· גיוס
- Hs0006 50711מיקוד מאומתTroy, United States· גיוס
- Hs0006 50712מיקוד מאומתניו יורק, ארצות הברית· גיוס
- Hs0006 50706מיקוד מאומתצ'אפל היל, ארצות הברית· גיוס
- Hs0006 50202מיקוד מאומתFairborn, United States· גיוס
- Hs0006 50201מיקוד מאומתArlington, United States· גיוס
שאלות נפוצות
What is Hidradenitis Suppurativa (HS)?
HS is a long-term skin condition that causes painful, inflamed bumps, boils, and sometimes tunnels to form under the skin, often in places where skin rubs together like armpits or groin.
What is Bimekizumab?
Bimekizumab is a new medication being tested. It's a type of 'biologic' medicine that targets specific parts of the immune system that cause inflammation in conditions like HS.
מה המשמעות של 'שלב 3' עבור מחקר?
Phase 3 means this is a later stage of testing. The medicine has already been studied for safety and basic effectiveness, and now it's being tested in a larger group of people to confirm its benefits and risks.
האם אצטרך לשלם כדי להשתתף במחקר?
No, all study-related treatments and assessments are provided free of charge if you qualify and choose to participate.
Can I continue my usual HS treatment while in the study?
Some existing treatments might need to be stopped or changed during the study. The study team will discuss this with you and explain which medications are allowed or not allowed.
כיצד לגלות עוד
UCB אכפת
תמיד התייעץ עם רופא המשפחה או המומחה שלך לפני שתחליט להשתתף במחקר.
מעוניינים להשתתף?
דיון
דיון קהילתי
מופעל על ידי הפורום שלנו ב community.patient.info. אנא היו מכבדים — זה אינו ייעוץ רפואי.