A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata.
A legfontosabb adatok
- Hol
- Albuquerque, Aurora, Austin, Charleston, Corpus Christi, El Paso, Hershey, Indianapolis, Irvine, Marriottsville, Miami, Milwaukee, Omaha, Pflugerville, Portland, San Antonio, Santa Ana, Skokie, Washington D.C. és Waterford (Egyesült Államok)Mind a 23 helyszín megnézése
- Fázis
- 3. fázis
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 6 és 14 év között vagy?
Forrás: NCT07029828: ki vehet részt
Helyszínek itt: Egyesült Államok
- University of New Mexico Health Sciences CenterAlbuquerque, Egyesült ÁllamokRésztvevőt keres
- University of New Mexico-IDS PharmacyAlbuquerque, Egyesült ÁllamokRésztvevőt keres
- Children's Hospital ColoradoAurora, Egyesült ÁllamokRésztvevőt keres
- Dell Children's Medical CenterAustin, Egyesült ÁllamokToborzás még nem indult
- Medical University of South Carolina - South Carolina Translational Research Nexus ClinicCharleston, Egyesült ÁllamokRésztvevőt keres
- Driscoll Children's HospitalCorpus Christi, Egyesült ÁllamokRésztvevőt keres
- 3A ResearchEl Paso, Egyesült ÁllamokRésztvevőt keres
- Penn State Health Milton S. Hershey Medical CenterHershey, Egyesült ÁllamokRésztvevőt keres
- Dawes Fretzin Clinical Research Group, LLCIndianapolis, Egyesült ÁllamokRésztvevőt keres
- University of California, IrvineIrvine, Egyesült ÁllamokRésztvevőt keres
- Kindred Hair and Skin CenterMarriottsville, Egyesült ÁllamokToborzás még nem indult
- Pediatric Skin ResearchMiami, Egyesült ÁllamokRésztvevőt keres
- Children's WisconsinMilwaukee, Egyesült ÁllamokToborzás még nem indult
- Medical College of WisconsinMilwaukee, Egyesült ÁllamokToborzás még nem indult
- Ear, Nose & Throat Consultants, LLCOmaha, Egyesült ÁllamokRésztvevőt keres
- Skin Specialists, PC dba Schlessinger MDOmaha, Egyesült ÁllamokRésztvevőt keres
- Austin Institute for Clinical ResearchPflugerville, Egyesült ÁllamokRésztvevőt keres
- Northwest Dermatology InstitutePortland, Egyesült ÁllamokRésztvevőt keres
- Texas Dermatology and Laser SpecialistsSan Antonio, Egyesült ÁllamokRésztvevőt keres
- Southern California Clinical ResearchSanta Ana, Egyesült ÁllamokRésztvevőt keres
- Endeavor Health Clinical OperationsSkokie, Egyesült ÁllamokRésztvevőt keres
- Children's National HospitalWashington D.C., Egyesült ÁllamokRésztvevőt keres
- Michigan Dermatology InstituteWaterford, Egyesült ÁllamokRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Pfizer
- Azonosító
- NCT07029828EU 2024-515439-31-00
- A regiszteradat frissítve
- 2026. október 15.
- Eredeti leírás
The purpose of this clinical trial is to learn about long-term safety and long-term effects of the study medicine (called ritlecitinib) for the potential treatment of severe alopecia areata, a condition that causes hair loss.A teljes eredeti leírásKevesebb
A LONG-TERM, DOUBLE-BLIND EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN PARTICIPANTS WITH SEVERE ALOPECIA AREATA WHO PREVIOUSLY COMPLETED STUDIES B7981027 OR B7981031
The purpose of this clinical trial is to learn about long-term safety and long-term effects of the study medicine (called ritlecitinib) for the potential treatment of severe alopecia areata, a condition that causes hair loss.
This study is seeking participants who have:
* previously completed one of Pfizer's pediatric studies for Alopecia Areata (B7981027 or B7981031). * at least 50% scalp hair loss due to alopecia areata (for participants enrolling from the study B7981031). * received varicella vaccination (2 doses) or have been infected by varicella zoster virus before based on blood test reports.
All participants in this study will receive the study medicine (ritlecitinib). Participants who received ritlecitinib higher or lower doses in the parent Study B7981027 will continue receiving the same ritlecitinib dose in this trial.
Participants who received placebo in the parent Study B7981027 and all participants from parent Study B7981031 will receive either higher or lower dose of ritlecitinib in this trial.
The study medicine is a capsule that is taken by mouth. It is taken 1 time each day at home.
The study will help see if ritlecitinib is safe and effective. Participants will take part in this study for a duration of up to 3 years (36 months). During this time, they will have 17 study visits at the study clinic. The study team will also call participants once a month over the phone.
Bevonási feltételek: Participants with alopecia areata (AA) (including alopecia totalis [AT] and alopecia universalis [AU]) who completed the studies B7981027 or B7981031; For participants originating from Study B7981031: At least 50% scalp hair loss due to AA (ie, a SALT score of ≥50) at both the Screening and Baseline visits.
Kizáró feltételek: Exclusion criteria for participants originating from Study B7981027 with ≤ 30 Days between last dose in Study B7981027 and first visit of Study B7981028; During Study B7981027 or in the period between the last dose of study intervention in Study B7981027 and the first dose of study intervention of Study B7981028, presence of safety events that would require permanent discontinuation based on the B7981028 protocol; Study participants discontinued from Study B7981027 due to issues other than safety-related events and considered by the investigator for enrolment in Study B7981028 must have resolution of the issue(s) resulting in discontinuation from the parent study prior to enrolment in Study B7981028; Exclusion criteria for participants originating from Study B7981031 or from Study B7981027 with >30 Days between last dose in Study B7981027 and first visit of Study B7981028; During Study B7981031 or Study B7981027 or in the period between the last dose of study intervention in Study B7981031 or Study B7981027 and the first dose of study intervention of Study B7981028, presence of safety events that would require permanent discontinuation based on the B7981028 protocol; Any present malignancies or history of malignancies or lymphoproliferative disorders; Evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection, history (one or more episodes) of severe or serious cytomegalovirus (CMV), herpes zoster (shingles) or disseminated herpes simplex, infection with hepatitis B virus (HBV) or hepatitis C virus (HCV); -.