A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata.
This study is for children with severe alopecia areata, a condition that causes significant hair loss. It's a long-term study to find out more about a medicine called ritlecitinib. The main goal is to see how safe the medicine is and how well it works over a longer period. Only children who have already taken part in one of Pfizer's earlier studies (B7981027 or B7981031) for alopecia areata can join this study. All participants will receive ritlecitinib, taken as a daily capsule. The study will last up to three years and involves regular visits to the clinic and phone calls to check on progress.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
This research study is looking into a medicine called ritlecitinib for children and young people who have severe alopecia areata. Alopecia areata is a condition where the body's immune system mistakenly attacks hair follicles, leading to hair loss, sometimes all over the head or body. Severe means a lot of hair loss, in this case, affecting at least half of the scalp.
The main aim of this study is to understand the long-term effects of ritlecitinib. We want to see how safe it is to take over a longer period and how well it helps with hair regrowth. The study is a continuation for children who have already taken part in a previous Pfizer study (named B7981027 or B7981031) looking at the same medicine. This means we're building on what we've already learned.
All participants will receive the study medicine, ritlecitinib, which is taken as a capsule once a day. Some participants will receive a higher dose, and others a lower dose. We hope this study will give us important information about how ritlecitinib can help children manage their alopecia areata in the long run.
النقاط الرئيسية
- This study is for children with severe alopecia areata who were in prior Pfizer studies.
- It aims to understand the long-term safety and effects of ritlecitinib.
- Participants take a daily capsule of ritlecitinib (either a higher or lower dose).
- The study lasts up to 3 years and involves clinic visits and phone calls.
- It helps researchers learn more about how to treat alopecia areata.
- Your health and safety will be carefully monitored throughout the study.
من قد يكون مؤهلاً؟
To be able to join this study, children must have previously taken part in one of Pfizer's earlier studies for alopecia areata (either B7981027 or B7981031). If they are joining from study B7981031, they need to have lost at least half of their scalp hair due to alopecia areata.
There are also some health requirements. Participants must have had the chickenpox vaccine (two doses) or have had chickenpox before, confirmed by a blood test. There are certain health conditions or past serious infections, including some types of cancer or long-term infections like TB or hepatitis, that would prevent someone from joining to ensure their safety.
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.
- Have I previously taken part in Pfizer's study B7981027 or B7981031?
- If I was in study B7981031, do I have at least 50% hair loss on my scalp?
- Have I had two chickenpox vaccinations or had chickenpox before?
- Do I have any current or past serious health issues like certain cancers or untreated infections (like TB or hepatitis)?
ماذا يتضمن المشاركة؟
If you join this study, you will take the study medicine, ritlecitinib, once a day as a capsule. You will be in the study for up to three years (36 months). During this time, you will have 17 visits to the study clinic for check-ups and assessments. The study team will also call you once a month to see how you are doing. These visits and calls help the doctors monitor your health and see how well the medicine is working. If the medicine isn't helping as expected after a certain time, or if there are safety concerns, your participation in the study medicine part might stop.
المخاطر والفوائد المحتملة
المواقع (67)
- University of California~ Irvineالرمز البريدي المؤكدإرفاين، الولايات المتحدة· التوظيف
- Southern California Clinical Researchالرمز البريدي المؤكدسانتا آنا، الولايات المتحدة· التوظيف
- مستشفى الأطفال كولورادوالرمز البريدي المؤكدأورورا، الولايات المتحدة· التوظيف
- مستشفى الأطفال الوطنيالرمز البريدي المؤكدواشنطن العاصمة، الولايات المتحدة· التوظيف
- Pediatric Skin Researchالرمز البريدي المؤكدميامي، الولايات المتحدة· التوظيف
- Endeavor Health Clinical Operationsالرمز البريدي المؤكدسكوك، الولايات المتحدة· التوظيف
- مجموعة داوز فريتزين للأبحاث السريرية، ذات المسؤولية المحدودةالرمز البريدي المؤكدإنديانابوليس، الولايات المتحدة· التوظيف
- Kindred Hair and Skin Centerالرمز البريدي المؤكدMarriottsville, United States· لم يبدأ التوظيف بعد
- Michigan Dermatology Instituteالرمز البريدي المؤكدWaterford, United States· التوظيف
- Ear, Nose & Throat Consultants, LLCالرمز البريدي المؤكدأوماها، الولايات المتحدة· التوظيف
- Skin Specialists, PC dba Schlessinger MDالرمز البريدي المؤكدأوماها، الولايات المتحدة· التوظيف
- University of New Mexico Health Sciences Centerالرمز البريدي المؤكدألبوكيرك، الولايات المتحدة· التوظيف
أسئلة شائعة
ما هو الريتليسيتينيب؟
Ritlecitinib is the name of the medicine being tested in this study. It's a type of drug that aims to help with hair loss caused by severe alopecia areata.
من يمكنه الانضمام إلى هذه الدراسة؟
Only children who have already taken part in Pfizer's previous alopecia areata studies (B7981027 or B7981031) can join this study.
كم ستستغرق مدة الدراسة؟
The study will last for up to three years (36 months).
Will I have to take daily medicine?
Yes, all participants in this study will take the study medicine, ritlecitinib, as a capsule once a day.
What kind of visits will I have?
You will have regular visits to the study clinic (17 over three years) and monthly phone calls with the study team.
كيفية معرفة المزيد
مركز اتصال Pfizer CT.gov
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
هل أنت مهتم بالمشاركة؟
نقاش
مناقشة المجتمع
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