A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata
This study is investigating a medicine called ritlecitinib for treating alopecia areata, a condition causing hair loss. Ritlecitinib is already approved in some countries at a 50mg dose. This study will compare that dose with a higher 100mg dose to see if it's also safe and effective. Researchers want to find out if the 100mg dose helps hair grow back and if it has any side effects. Participants, aged 12 and older with significant scalp hair loss due to alopecia areata, will take part. They will be randomly assigned to receive one of the doses, or a dummy pill (placebo), and will be observed for about 13 months with regular check-ups.
एक नजर में
यह अध्ययन किस बारे में है?
Alopecia areata is a common condition where the immune system mistakenly attacks hair follicles, leading to hair loss on the scalp, face, and sometimes other parts of the body. While there are some treatments available, researchers are always looking for new and effective options.
This particular study is focusing on a medicine called ritlecitinib. It's designed to help calm down the immune system's overreaction that causes hair loss. A 50mg dose of ritlecitinib is already used in many countries for severe alopecia areata in people aged 12 and above. Now, doctors want to see if a higher 100mg dose might be even more effective, while still being safe.
The main goal of this study is to compare the 50mg and 100mg doses of ritlecitinib. They want to check how well both doses work in helping hair grow back, as well as keeping a close eye on any potential side effects. By carefully studying these two doses, researchers hope to better understand the best way to use ritlecitinib to help people living with alopecia areata.
मुख्य निष्कर्ष
- This study evaluates two doses (50mg and 100mg) of ritlecitinib for alopecia areata.
- Ritlecitinib aims to help hair regrowth by addressing the immune system.
- Participants will be aged 12 and older with significant scalp hair loss.
- The study lasts about 13 months with regular clinic visits.
- You will be randomly assigned to receive ritlecitinib or a placebo.
- Participation includes various health checks and questionnaires.
कौन पात्र हो सकता है?
To join this study, you need to be at least 12 years old and have a clear diagnosis of alopecia areata. This means your doctor has confirmed your hair loss is due to this specific condition, and not something else. You must also have lost at least half of the hair on your scalp.
It's important that your hair loss specifically due to alopecia areata and not another medical issue. Also, your current episode of hair loss shouldn't have started more than 10 years ago. You must be willing to stop any other alopecia areata treatments you're currently using while you're in the study.
There are also some reasons why you might not be able to join. For example, if you have other conditions that cause hair loss, a history of serious allergic reactions to similar medicines, or certain infections, you might not be eligible. The study team will discuss all these details with you thoroughly to make sure taking part is safe and suitable for you.
क्या यह अध्ययन आपके लिए उपयुक्त हो सकता है?
यह देखने के लिए इन त्वरित प्रश्नों का उत्तर दें कि क्या आप पात्र हो सकते हैं। यह केवल एक मार्गदर्शिका है — अंतिम निर्णय शोध टीम द्वारा लिया जाता है।.
- Are you 12 years of age or older?
- Have you been diagnosed with alopecia areata?
- Have you lost 50% or more of the hair on your scalp?
- Is your current hair loss episode 10 years old or less?
- Are you willing to stop any other alopecia areata treatments if you join?
भागीदारी में क्या शामिल है?
If you join this study, you'll be involved for about 13 months. During this time, you'll be asked to visit the study clinic up to 9 times. When you join, you'll be randomly assigned, like drawing names out of a hat, to receive one of the two doses of ritlecitinib (50mg or 100mg), or a dummy pill called a placebo. You'll take your assigned medicine by mouth once a day.
During your visits, the study team will carry out several checks. These will include assessing your hair loss, having physical examinations, hearing tests, and blood tests. You might also have an X-ray and an ECG (a test that checks your heart's electrical activity). They'll take photographs of your scalp and eyes to track any changes. You'll also be asked to fill in some questionnaires about your alopecia areata and how you're feeling.
संभावित जोखिम और लाभ
Locations (148)
- The Kirklin Clinic of UAB Hospital (Radiology)सत्यापित पोस्टकोडबर्मिंघम, संयुक्त राज्य अमेरिका· भर्ती
- University of Alabama at Birmingham Faculty Office Towers (Regulatory)सत्यापित पोस्टकोडबर्मिंघम, संयुक्त राज्य अमेरिका· भर्ती
- बर्मिंघम में अलबामा विश्वविद्यालयसत्यापित पोस्टकोडबर्मिंघम, संयुक्त राज्य अमेरिका· भर्ती
- Burke Pharmaceutical Researchसत्यापित पोस्टकोडहॉट स्प्रिंग्स, संयुक्त राज्य अमेरिका· सक्रिय लेकिन भर्ती नहीं
- Doc1 Healthcare Systemsसत्यापित पोस्टकोडब्रेआ, संयुक्त राज्य अमेरिका· भर्ती
- California Dermatology & Clinical Research Instituteसत्यापित पोस्टकोडEncinitas, United States· सक्रिय लेकिन भर्ती नहीं
- Marvel Clinical Researchसत्यापित पोस्टकोडहंटिंगटन बीच, संयुक्त राज्य अमेरिका· सक्रिय लेकिन भर्ती नहीं
- University of California - Irvineसत्यापित पोस्टकोडइरविन, संयुक्त राज्य अमेरिका· भर्ती
- Gavin Herbert Eye Instituteसत्यापित पोस्टकोडइरविन, संयुक्त राज्य अमेरिका· भर्ती
- Southern California Clinical Researchसत्यापित पोस्टकोडSanta Ana, United States· सक्रिय लेकिन भर्ती नहीं
- Brett King MD, LLCसत्यापित पोस्टकोडFairfield, United States· भर्ती
- Alliance for Multispecialty Research, LLCसत्यापित पोस्टकोडफोर्ट मायर्स, संयुक्त राज्य अमेरिका· सक्रिय लेकिन भर्ती नहीं
सामान्य प्रश्न
What is alopecia areata?
Alopecia areata is a condition where your immune system attacks your hair follicles, leading to patches of hair loss on your scalp, face, and sometimes other parts of your body.
What is ritlecitinib?
Ritlecitinib is a type of medicine designed to help calm the immune system's activity that causes hair loss in alopecia areata.
प्लेसबो क्या है?
प्लेसबो एक नकली गोली है जो अध्ययन की दवा की तरह दिखती है लेकिन इसमें कोई सक्रिय दवा नहीं होती। यह शोधकर्ताओं को असली दवा के प्रभावों की तुलना करने में मदद करता है।.
मैं अध्ययन में कितने समय तक रहूँगा?
If you join, you'll be part of the study for about 13 months, with up to 9 visits to the clinic during that time.
Can I continue my other hair loss treatments?
No, if you join this study, you'll need to stop any other treatments you're currently taking for your alopecia areata.
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