A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
This research study is investigating a new medication called baricitinib for children and teenagers aged 6 to 17 who have severe alopecia areata. Alopecia areata is a condition where the body's immune system mistakenly attacks hair follicles, leading to hair loss. The main goal of this study is to find out how well baricitinib works to help hair regrow and whether it is safe for young people. Participants will receive either baricitinib or a placebo (a dummy drug with no active medicine) in the first part of the study. The study involves several stages, including an initial check-up period, a main treatment period, and a longer-term follow-up to see how participants do over time. This research is important because it could offer a new treatment option for young people living with this challenging condition.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
This study is about a medicine called baricitinib and its use in treating severe alopecia areata in young people. Alopecia areata is an autoimmune condition, meaning the body's own immune system wrongly attacks hair follicles. This leads to hair loss on the scalp and sometimes other parts of the body. For children and teenagers, living with this condition can be particularly difficult, affecting their self-esteem and daily life.
The study aims to understand two main things: how effective baricitinib is at helping hair regrow, and if it is safe for children and teenagers. Baricitinib works by calming down the overactive immune system that causes hair loss in alopecia areata. Researchers want to see if this medicine can make a real difference for young people who haven't found other treatments helpful.
Participants will be given either baricitinib or a placebo, which looks exactly like the study medicine but contains no active ingredients. This is a common way to test new medicines fairly, so researchers can accurately tell if any improvements are due to the treatment itself. The study has different stages, starting with checks to ensure participants are suitable, moving into the main treatment period, and then a longer follow-up period to monitor progress.
النقاط الرئيسية
- This study is for children and teenagers (6-17) with severe alopecia areata.
- It's testing a medicine called baricitinib for safety and hair regrowth.
- Participants will receive either baricitinib or a dummy medicine (placebo) in the first phase.
- The study involves regular visits, check-ups, and can last for several years.
- It could offer a new treatment option for young people with alopecia areata.
- يمكنك الانسحاب من الدراسة في أي وقت.
من قد يكون مؤهلاً؟
To be considered for this study, young people generally need to be between 6 and 17 years old and have had severe alopecia areata for at least a year. Their current hair loss episode should have lasted for at least six months, and a specific measure of hair loss, called a SALT score, needs to be 50% or higher. This score helps doctors understand how much hair loss there is. Participants should also have tried at least one other treatment for their alopecia that didn't work.
There are also reasons why someone might not be able to join. For example, if they have certain other health conditions, such as other types of hair loss, untreated high blood pressure, or serious heart, liver, or kidney problems. The study also cannot include individuals who have been largely unable to care for themselves or have had major surgery recently. It's important that participants don't have certain infections like active hepatitis B or C.
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.
- هل عمرك بين 6 و 17 سنة؟
- Have you had severe alopecia areata for at least one year?
- Has your current hair loss episode lasted at least six months?
- Have you tried at least one other treatment for alopecia areata that didn't work?
- Do you have any other serious long-term health conditions?
- Have you had a major surgery recently or are you likely to need one during the study?
ماذا يتضمن المشاركة؟
If you decide to take part, the study will involve several stages over a long period. First, there's a 5-week 'Screening' period where doctors will do tests to see if you're suitable for the study. If you are, you'll then enter a 'Double-Blind Treatment Period' lasting for 36 weeks. During this time, you'll be given either the study medicine (baricitinib) or a placebo, but neither you nor your doctor will know which one you're receiving.
After this, there's an 'approximately 2-year Long-Term Extension' period where all participants who continue in the study will likely receive the active medicine. Finally, there's a 4-week 'Post-treatment Follow-up' to check on your health after the main treatment ends. Some participants might even be able to continue receiving treatment for even longer, up to a total of 180 weeks. Throughout the study, you'll have regular visits to the clinic for check-ups, blood tests, and to see how your hair is responding.
المخاطر والفوائد المحتملة
Locations (127)
- Total Skin and Beauty Dermatology Center, PCالرمز البريدي المؤكدبرمنغهام، الولايات المتحدة· التوظيف
- جامعة ألاباما في برمنغهامالرمز البريدي المؤكدبرمنغهام، الولايات المتحدة· لم يبدأ التوظيف بعد
- Investigate MDالرمز البريدي المؤكدسكوتسديل، الولايات المتحدة· التوظيف
- California Dermatology & Clinical Research Instituteالرمز البريدي المؤكدإنسينيتاس، الولايات المتحدة· لم يبدأ التوظيف بعد
- Dermatology Research Associatesالرمز البريدي المؤكدلوس أنجلوس، الولايات المتحدة· التوظيف
- University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatologyالرمز البريدي المؤكدسان دييغو، الولايات المتحدة· التوظيف
- The Permanente Medical Group, Inc.الرمز البريدي المؤكدسان فرانسيسكو، الولايات المتحدة· التوظيف
- Southern California Dermatology, Inc.الرمز البريدي المؤكدسانتا آنا، الولايات المتحدة· التوظيف
- Dermatology Physicians of Connecticutالرمز البريدي المؤكدفيرفيلد، الولايات المتحدة· لم يبدأ التوظيف بعد
- Skin Care Research, Incالرمز البريدي المؤكدبوكا راتون، الولايات المتحدة· لم يبدأ التوظيف بعد
- Florida Academic Centers Research and Education, LLCالرمز البريدي المؤكدكورال غيبلز، الولايات المتحدة· مكتمل
- D&H Doral Research Center LLCالرمز البريدي المؤكددورال، الولايات المتحدة· لم يبدأ التوظيف بعد
أسئلة شائعة
What is alopecia areata?
Alopecia areata is a condition where your body's immune system mistakenly attacks your hair follicles, causing hair to fall out, usually in patches.
What is baricitinib?
Baricitinib is a medicine that works by calming down certain parts of your immune system that are overactive in conditions like alopecia areata.
ما هو الدواء الوهمي؟
A placebo is a 'dummy' pill or treatment that looks exactly like the real medicine but contains no active ingredients. It's used to compare against the real medicine.
كم ستستغرق مدة الدراسة؟
The main part of the study lasts about 36 weeks, but with screening, extensions, and follow-up, your overall participation could be up to about 3 years, and potentially longer for some.
هل سأحصل بالتأكيد على الدواء الفعال؟
In the initial 36-week treatment period, you have a chance of receiving either the active medicine or a placebo. In the longer-term extension period, participants typically receive the active medicine.
كيفية معرفة المزيد
أسئلة التجارب أو أسئلة المشاركة: 1-877-CTLILLY (1-877-285-4559) أو
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
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نقاش
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