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.
במבט חטוף
על מה המחקר הזה?
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.
נקודות עיקריות
- 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.
מי עשוי להיות זכאי?
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.
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.
- 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)?
מה כרוך בהשתתפות?
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.
סיכונים ותועלות פוטנציאליים
Locations (67)
- University of California~ Irvineמיקוד מאומתאירוויין, ארצות הברית· גיוס
- Southern California Clinical Researchמיקוד מאומתSanta Ana, United States· גיוס
- בית החולים לילדים קולורדומיקוד מאומתאורורה, ארצות הברית· גיוס
- בית החולים הלאומי לילדיםמיקוד מאומתוושינגטון די.סי., ארצות הברית· גיוס
- Pediatric Skin Researchמיקוד מאומתמיאמי, ארצות הברית· גיוס
- Endeavor Health Clinical Operationsמיקוד מאומתSkokie, United States· גיוס
- קבוצת מחקר קליני דואס פרטזין, LLCמיקוד מאומתאינדיאנפוליס, ארצות הברית· גיוס
- Kindred Hair and Skin Centerמיקוד מאומתMarriottsville, United States· עדיין לא מגייסים
- Michigan Dermatology Instituteמיקוד מאומתWaterford, United States· גיוס
- Ear, Nose & Throat Consultants, LLCמיקוד מאומתOmaha, United States· גיוס
- Skin Specialists, PC dba Schlessinger MDמיקוד מאומתOmaha, United States· גיוס
- University of New Mexico Health Sciences Centerמיקוד מאומתAlbuquerque, United States· גיוס
שאלות נפוצות
What is ritlecitinib?
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.
מי יכול להצטרף למחקר זה?
Only children who have already taken part in Pfizer's previous alopecia areata studies (B7981027 or B7981031) can join this study.
כמה זמן יימשך המחקר?
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.
איזה סוג ביקורים יהיו לי?
You will have regular visits to the study clinic (17 over three years) and monthly phone calls with the study team.
כיצד לגלות עוד
מרכז שיחות של פייזר CT.gov
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