Patientforskning
Logga in
Alla studier
RekryteringFAS3INTERVENTIONELL

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.

Överblick

Status
Rekrytering
Fas
FAS3
Sponsor
Pfizer
Inskrivningsmål
140
Starta
10 Sep 2025
Beräknad slutförande
26 Jun 2030
Severe Alopecia Areata

Vad handlar denna studie om?

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.

Viktiga punkter

  • 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.

Vem kan vara berättigad?

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.

Kan denna studie passa dig?

Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.

  1. Have I previously taken part in Pfizer's study B7981027 or B7981031?
  2. If I was in study B7981031, do I have at least 50% hair loss on my scalp?
  3. Have I had two chickenpox vaccinations or had chickenpox before?
  4. Do I have any current or past serious health issues like certain cancers or untreated infections (like TB or hepatitis)?
Svara på varje fråga för att se ditt resultat.

Vad innebär deltagande?

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.

Potentiella risker och fördelar

Taking part in this study could offer the potential benefit of continuing treatment for your alopecia areata with ritlecitinib, which may help with hair regrowth. However, like all medicines, ritlecitinib can have side effects, and the study will carefully monitor for any potential risks. You will be told about all known risks before you decide to join. Remember, participation is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (67)

  • University of California~ Irvine
    Verifierat postnummer
    Irvine, USA· Rekrytering
  • Southern California Clinical Research
    Verifierat postnummer
    Santa Ana, USA· Rekrytering
  • Barnsjukhuset Colorado
    Verifierat postnummer
    Aurora, USA· Rekrytering
  • Barnens Nationella Sjukhus
    Verifierat postnummer
    Washington D.C., USA· Rekrytering
  • Pediatric Skin Research
    Verifierat postnummer
    Miami, USA· Rekrytering
  • Endeavor Health Clinical Operations
    Verifierat postnummer
    Skokie, United States· Rekrytering
  • Dawes Fretzin Clinical Research Group, LLC
    Verifierat postnummer
    Indianapolis, USA· Rekrytering
  • Kindred Hair and Skin Center
    Verifierat postnummer
    Marriottsville, United States· Rekryterar inte ännu
  • Michigan Dermatology Institute
    Verifierat postnummer
    Waterford, United States· Rekrytering
  • Ear, Nose & Throat Consultants, LLC
    Verifierat postnummer
    Omaha, United States· Rekrytering
  • Skin Specialists, PC dba Schlessinger MD
    Verifierat postnummer
    Omaha, United States· Rekrytering
  • University of New Mexico Health Sciences Center
    Verifierat postnummer
    Albuquerque, United States· Rekrytering

Vanliga frågor

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.

Vem kan delta i denna studie?

Only children who have already taken part in Pfizer's previous alopecia areata studies (B7981027 or B7981031) can join this study.

Hur länge kommer studien att pågå?

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.

Vilken typ av besök kommer jag att ha?

You will have regular visits to the study clinic (17 over three years) and monthly phone calls with the study team.

Hur du får reda på mer

Pfizer CT.gov Callcenter

clinicaltrials.gov_inquiries@pfizer.com 1-800-718-1021 Officiell rättegångsprotokoll

Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.

Intresserad av att delta?

Registrera ditt intresse

Dela dina uppgifter och forskarteamet för "A Long-Term Study to Learn About The Study Medicine Called R…" kommer att kontakta dig om du kan vara berättigad. Prata alltid med din läkare innan du går med på att delta.

Diskussion

Gemenskapsdiskussion

Drivs av vårt forum på community.patient.info. Var vänlig och respektfull — detta är inte medicinsk rådgivning.