A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss)
This research study is looking into a new medicine called LY4005130 for adults with severe alopecia areata, a condition where people experience significant hair loss. The main goals are to find out how effective this medicine is at helping hair regrow compared to a 'dummy' treatment (placebo), and to understand any side effects it might cause. Researchers will also take blood tests to see how the body handles the medicine and how the medicine affects the body. The medicine will be given directly into a vein in the arm. The study will last for about 48 weeks, which is roughly 11-12 months, including an initial checking period.
במבט חטוף
על מה המחקר הזה?
Alopecia areata is a condition where your immune system mistakenly attacks your hair follicles, leading to hair loss. This study is exploring a potential new treatment, called LY4005130, for people with a severe form of this condition. The aim is to see if this new medicine can help people grow their hair back, and how it compares to not receiving the active medicine.
Researchers will carefully compare the new medicine to a 'placebo', which looks exactly like the medicine but contains no active ingredients. This is a standard way to test new treatments, as it helps determine if any changes or improvements are truly due to the medicine itself rather than other factors. They will also be closely monitoring participants for any side effects to understand how well the medicine is tolerated by the body. Blood tests will be part of the study to help us understand how your body uses and responds to the medicine.
Understanding how new treatments work and what their side effects might be is really important for developing better ways to help people with alopecia areata. This study is a stepping stone in that process, providing valuable information that could one day lead to approved medicines to help manage this condition.
נקודות עיקריות
- Tests a new medicine (LY4005130) for severe alopecia areata.
- Compares the medicine to a dummy treatment (placebo).
- Aims to understand effectiveness and potential side effects.
- Medicine given into a vein; involves regular clinic visits.
- Total study duration is about 48 weeks.
- Suitable for adults aged 18-50 with specific hair loss criteria.
מי עשוי להיות זכאי?
This study is looking for adults aged between 18 and 50 years old. To join, you must have severe alopecia areata, meaning you've lost hair on at least half, but not more than 90%, of your scalp. Your current hair loss episode must have lasted for at least 6 months but no longer than 4 years, and your hair shouldn't have grown back much on its own in the last six months.
You cannot join this study if you have a different type of hair loss, or if you are currently using other alopecia areata treatments or planning to use them during the study. It's also not suitable for you if you've had certain other treatments in the past, like specific 'JAK inhibitors' medicines, or if you've had major surgery recently or need one soon.
Also, if you have other serious health conditions that need frequent hospital visits or strong medicines, or specific heart, lung, stomach, or other disorders, this study might not be safe for you. The study team will review your full medical history to make sure it's safe for you to take part.
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.
- האם אתה בין גיל 18 ל-50?
- Have you lost more than half, but not all, of your scalp hair from alopecia areata?
- Has your current hair loss lasted for at least 6 months but no more than 4 years?
- Have you avoided specific hair loss treatments like JAK inhibitors in the past?
- Are you generally in good health without other serious medical conditions?
- Are you able to commit to regular clinic visits for about 48 weeks?
מה כרוך בהשתתפות?
If you decide to take part in this study, the study medicine, LY4005130, will be given to you directly into a vein in your arm (this is called an intravenous or IV infusion). You will receive either the active medicine or a placebo (a dummy medicine) – you won't know which one you are getting. During the study, you will have several appointments at the study clinic. These visits will involve various checks, such as measuring your hair loss, physical examinations, and taking blood samples. These blood tests help us understand how the medicine is working and how your body is reacting to it. The entire study, including the initial checks to see if you can join, will last for about 48 weeks, which is nearly a year.
סיכונים ותועלות פוטנציאליים
Locations (30)
- Center For Dermatology Clinical Research, Inc.מיקוד מאומתFremont, United States· גיוס
- Northridge Clinical Trialsמיקוד מאומתNorthridge, United States· גיוס
- Cura Clinical Research - Santa Clarita - Kelly Johnson Parkwayמיקוד מאומתSanta Clarita, United States· גיוס
- Health Clinical Research, LLCמיקוד מאומתקאטלר ביי, ארצות הברית· גיוס
- Brigham and Women's Hospitalמיקוד מאומתבוסטון, ארצות הברית· גיוס
- Revival Research Institute, LLCמיקוד מאומתTroy, United States· גיוס
- Stracskinמיקוד מאומתPortsmouth, United States· גיוס
- Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenueמיקוד מאומתסן אנטוניו, ארצות הברית· גיוס
- Jordan Valley Dermatology & Research Centerמיקוד מאומתSouth Jordan, United States· גיוס
- Kelowna Health and Memory Centreמיקוד מאומתKelowna, Canada· גיוס
- Ryan Clinical Research Inc.מיקוד מאומתNewmarket, Canada· גיוס
- Dar Clinical Research - Ottawa - Hunt Club Roadמיקוד מאומתאוטווה, קנדה· גיוס
שאלות נפוצות
What is alopecia areata?
Alopecia areata is an autoimmune condition where your immune system mistakenly attacks your hair follicles, causing hair to fall out in patches or, in severe cases, all over the body.
What is LY4005130?
LY4005130 is the name of the new experimental medicine being tested in this study for severe alopecia areata.
What does 'placebo' mean in a study?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It helps researchers compare if the new medicine is actually effective.
How will I receive the study medicine?
The study medicine will be given to you directly into a vein in your arm, similar to getting a drip.
כמה זמן יימשך המחקר אם אצטרף?
If you join this study, it will last for about 48 weeks in total, which is nearly a year.
כיצד לגלות עוד
שאלות לגבי הניסוי או שאלות השתתפות: 1-877-CTLILLY (1-877-285-4559) או
תמיד התייעץ עם רופא המשפחה או המומחה שלך לפני שתחליט להשתתף במחקר.
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