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Die klinische Studie NCT07029711 (B7981027) für Severe Alopecia Areata ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
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PfizerA Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata (B7981027) Phase 3 225 Zu Hause
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07029711 (B7981027) untersucht Behandlung im Zusammenhang mit Severe Alopecia Areata. Diese interventionsstudie der Phase 3 hat den Status offene rekrutierung und startete am 31. Juli 2025. Es ist geplant, 225 Teilnehmer aufzunehmen. Durchgeführt von Pfizer wird der Abschluss für 18. Mai 2027 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 30. März 2026 aktualisiert.
Kurzbeschreibung
The purpose of this study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the possible treatment of severe alopecia areata. Alopecia areata is a condition that causes hair loss.
This study is seeking participants who have:
- at least 50% scalp hair loss due to alopecia areata.
- received varicella vaccination (2 doses) or have been infected by varicella zoster virus before b...
Ausführliche Beschreibung
Study B7981027 is being conducted to assess efficacy and safety of ritlecitinib in pediatric participants 6 to <12 years of age with severe AA. The primary objective of this study is to evaluate the efficacy of ritlecitinib compared to placebo in pediatric participants with severe AA on regrowth of lost scalp hair. The secondary objectives are to evaluate safety, tolerability, acceptability and palatability of ritle...Mehr anzeigen
Offizieller Titel
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF RITLECITINIB IN PEDIATRIC PARTICIPANTS 6 TO LESS THAN 12 YEARS OF AGE WITH SEVERE ALOPECIA AREATA
Erkrankungen
Severe Alopecia AreataWeitere Studien-IDs
- B7981027
- 2024-515438-33-00 (Registerkennung) (CTIS (EU))
NCT-Nummer
Studienbeginn (tatsächlich)
2025-07-31
Zuletzt aktualisiert
2026-03-30
Studienende (vorauss.)
2027-05-18
Geplante Rekrutierung
225
Studientyp
Interventionsstudie
PHASE
Phase 3
Status
Offene Rekrutierung
Stichwörter
Alopecia areata
Children
Ritlecitinib
Children
Ritlecitinib
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Vierfach verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellRitlecitinib higher dose Participants will receive
1 ritlecitinib higher dose capsule once a day (QD) and 1 placebo lower dose capsule once a day (QD) orally for 24 weeks. | Ritlecitinib higher dose Study intervention will be provided as oral capsules centrally by the sponsor in high-density polyethylene (HDPE) bottles. |
ExperimentellRitlecitinib lower dose Participants will receive
1 ritlecitinib lower dose capsule QD and 1 placebo higher dose capsule QD orally for 24 weeks. | Ritlecitinib lower dose Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles. |
Placebo-VergleichspräparatPlacebo Participants will receive
1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD orally for 24 weeks. | PLACEBO Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
For US and Countries Following US Analysis Plan: Response based on achieving an absolute Severity of Alopecia Tool (SALT) score ≤20. | The difference in proportions of participants with the SALT ≤20 response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 24 |
For EU/UK and Countries Following EU/UK Analysis Plan: Response based on achieving an absolute SALT score ≤10. | The difference in proportions of participants with the SALT ≤10 response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 24 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
For EU/UK and Countries Following EU/UK Analysis Plan: Patient Global Impression of Change (PGI-C) response defined as a score of "moderately improved" or "greatly improved". | The difference in proportions of participants with the PGI-C response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 24 |
For all countries: Change from baseline (CFB) in SALT score. | The difference in means/proportions in the SALT Score at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. |
For all countries: Response based on achieving absolute SALT score ≤20 at all visits (except for that included as the primary endpoint). | The difference in means/proportions in the endpoint at all scheduled time points (except for that included as the primary endpoints) between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18 |
For all countries: Response based on achieving absolute SALT score ≤10 at all visits (except for that included as the primary endpoint). | The difference in means/proportions in the endpoint at all scheduled time points (except for that included as the primary endpoints) between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18. |
For all countries: PGI-C response at all visits (except for that included as a key secondary endpoint). | The difference in proportions of participants with the PGI-C response at all scheduled time points (except for that included as key secondary endpoint) between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18. |
For all countries: Response based on improvement from baseline for each Alopecia Areata Patient Priority Outcomes (AAPPO) item. | The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. |
For all countries: CFB in Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Depressive Symptoms T-score. | The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. |
For all countries: CFB in PROMIS Parent Proxy Anxiety Symptoms T-score. | The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. |
For all countries: CFB in BRIEF®2 T-scores for the 3 index scores (Behavior Regulation Index (BRI), Emotion Regulation Index (ERI), Cognitive Regulation Index (CRI)). | The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. |
For all countries: CFB in modified Children's Dermatology Life Quality Index (CDLQI) total score. | The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. |
For all countries: Response based on achieving at least 2 grade improvement or a score of 3 in Eyebrow Assessment (EBA) score in participants with an abnormal EBA at baseline. | The difference in proportions of participants with the EBA response at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. |
For all countries: Response based on achieving at least 2 grade improvement or a score of 3 in Eyelash Assessment (ELA) score in participants with an abnormal ELA at baseline. | The difference in proportions of participants with the ELA response at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. |
For all countries: Plasma concentration of ritlecitinib. | Post dose hour 1 and hour 3 at day 28 or day 56. | |
For all countries: Incidence of treatment emergent Adverse Events (AEs). | To evaluate safety and tolerability of ritlecitinib over time. | From the time participant signs informed consent/assent, through and including a minimum of 28 calendar days after the last administration of the study intervention (up to approximately 8 months). |
For all countries: Incidence of Serious Adverse Events (SAEs) and AEs leading to permanent discontinuation from the study. | To evaluate safety and tolerability of ritlecitinib over time. | From the time participant signs informed consent/assent, through and including a minimum of 28 calendar days after the last administration of the study intervention (up to approximately 8 months). |
CFB in AAPPO activity limitation score. | The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. |
For all countries: Acceptability and palatability assessment. | To evaluate acceptability and palatability of the age-appropriate formulation. | Week 2 and Week 18 |
CFB in AAPPO emotional symptoms score. | The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind
Mindestalter
6 Years
Zugelassene Geschlechter
Alle
- A diagnosis of AA (including alopecia totalis (AT) and alopecia universalis (AU)) with at least 50% scalp hair loss due to AA (ie, SALT score of ≥50) at both screening and baseline visits, without evidence of terminal hair regrowth within the previous 12 months.
- For study participants in the EU/UK only: History of clinical response failure to AA treatment (such as topical, off-label pharmacologic, or hairpiece prosthetics)
- Documented evidence of having received varicella vaccination (2 doses), OR evidence of prior exposure to varicella zoster virus (VZV) based on serological testing (ie, a positive VZV Immunoglobulin G (IgG) antibody (Ab) result) at screening.
- Other (non-AA) types of alopecia, including any known congenital cause of AA.
- Pre-existing hearing loss.
- Any present or history of malignancies or lymphoproliferative disorder such as Epstein-Barr virus (EBV) related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
- Clinically significant depression per PROMIS Parent Proxy Short Form - Depressive symptoms (T-score ≥70).
- Any evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection; history (one or more episodes) of severe or serious cytomegalovirus (CMV) infection, herpes zoster (shingles) or disseminated herpes simplex; infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Vaccination with live attenuated replication-competent vaccine within 6 weeks of first dose of study intervention.
PfizerZentrale Studienkontakte
Kontakt: Pfizer CT.gov Call Center, 1-800-718-1021, [email protected]
80 Studienstandorte in 10 Ländern
California
California Dermatology & Clinical Research Institute, Encinitas, California, 92024, United States
Offene Rekrutierung
University of California - Irvine, Irvine, California, 92617, United States
Offene Rekrutierung
Investigational Drug Service - Rady Children's Hospital-San Diego, San Diego, California, 92123, United States
Offene Rekrutierung
University of California, San Diego/Rady Children's Hospital-San Diego;, San Diego, California, 92123, United States
Offene Rekrutierung
Southern California Clinical Research, Santa Ana, California, 92701, United States
Offene Rekrutierung
Colorado
Children's Hospital Colorado, Aurora, Colorado, 80045, United States
Offene Rekrutierung
District of Columbia
Children's National Medical Center, Washington D.C., District of Columbia, 20010, United States
Offene Rekrutierung
Florida
Pediatric Skin Research, Miami, Florida, 33156, United States
Offene Rekrutierung
D&H Tamarac Research Center, Tamarac, Florida, 33321, United States
Offene Rekrutierung
Illinois
Endeavor Health Clinical Operations, Skokie, Illinois, 60077, United States
Offene Rekrutierung
Indiana
Dawes Fretzin Clinical Research Group, LLC, Indianapolis, Indiana, 46250, United States
Offene Rekrutierung
Kentucky
Equity Medical - Bowling Green, Bowling Green, Kentucky, 42104, United States
Offene Rekrutierung
Maryland
Kindred Hair and Skin Center, Marriottsville, Maryland, 21104, United States
Offene Rekrutierung
Michigan
Michigan Dermatology Institute, Waterford, Michigan, 48328, United States
Offene Rekrutierung
Minnesota
University of Minnesota Health Clinical Research Unit (M Health CRU), Minneapolis, Minnesota, 55455, United States
Offene Rekrutierung
Nebraska
Ear, Nose and Throat Consultants, LLC, Omaha, Nebraska, 68144, United States
Offene Rekrutierung
Skin Specialists, PC dba Schlessinger MD, Omaha, Nebraska, 68144, United States
Offene Rekrutierung
Complete Behavior Health (Dr. Brittany Marshall, Licensed Psychologist), Papillion, Nebraska, 68046, United States
Offene Rekrutierung
New Mexico
University of New Mexico Health Sciences Center, Albuquerque, New Mexico, 87102, United States
Offene Rekrutierung
University of New Mexico-IDS Pharmacy, Albuquerque, New Mexico, 87106, United States
Offene Rekrutierung
Regents of the University of New Mexico, Albuquerque, New Mexico, 87131, United States
Offene Rekrutierung
New York
Equity Medical, New York, New York, 10455, United States
Offene Rekrutierung
Oregon
Northwest Dermatology Institute, Portland, Oregon, 97210, United States
Offene Rekrutierung
Pennsylvania
Penn State Health Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033, United States
Offene Rekrutierung
South Carolina
Medical University of South Carolina Department of Dermatology and Dermatologic Surgery, Charleston, South Carolina, 29425, United States
Offene Rekrutierung
Texas
Driscoll Children's Hospital, Corpus Christi, Texas, 78411, United States
Offene Rekrutierung
3A Research - West Location, El Paso, Texas, 79902, United States
Aktiv, nicht rekrutierend
Austin Institute for Clinical Research, Pflugerville, Texas, 78660, United States
Offene Rekrutierung
Texas Dermatology and Laser Specialists, San Antonio, Texas, 78218, United States
Offene Rekrutierung
Alberta
Laser Rejuvenation Clinics Edmonton D.T. Inc, Edmonton, Alberta, T5J 3S9, Canada
Offene Rekrutierung
CaRe Clinic, Red Deer, Alberta, T4P 1K4, Canada
Offene Rekrutierung
Ontario
Medicine Professional Corporation, Peterborough, Ontario, K9J 5K2, Canada
Offene Rekrutierung
Research Toronto, Toronto, Ontario, M4W 2N4, Canada
Offene Rekrutierung
Beijing Municipality
China-Japan Friendship Hospital, Beijing, Beijing Municipality, 100029, China
Offene Rekrutierung
Beijing Children's hospital, Capital Medical University, Beijing, Beijing Municipality, 100045, China
Offene Rekrutierung
Beijing Tongren Hospital affiliated to Capital Medical University, Beijing, Beijing Municipality, 100730, China
Offene Rekrutierung
Chongqing Municipality
The Second Affiliated Hospital Chongqing Medical University, Chongqing, Chongqing Municipality, 400010, China
Offene Rekrutierung
Guangdong
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, 510140, China
Offene Rekrutierung
Hunan
Hunan Children's Hospital, Changsha, Hunan, 410007, China
Offene Rekrutierung
Xiangya Hospital Central South University, Changsha, Hunan, 410008, China
Noch nicht rekrutierend
Shanghai Municipality
Huashan Hospital, Fudan University, Shanghai, Shanghai Municipality, 200040, China
Offene Rekrutierung
Sichuan
Chengdu Women and Children Center Hospital, Chengdu, Sichuan, 610091, China
Offene Rekrutierung
Yunnan
First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, 650032, China
Offene Rekrutierung
Kunming Children's hospital, Kunming, Yunnan, 650103, China
Noch nicht rekrutierend
Zhejiang
The First People's Hospital of Hangzhou, Hangzhou, Zhejiang, 310006, China
Offene Rekrutierung
Hangzhou Third Hospital, Hangzhou, Zhejiang, 310009, China
Offene Rekrutierung
Shanghai Children's Hospital, Shanghai, 200062, China
Offene Rekrutierung
Fakultni Nemocnice Plzen, Pilsen, 305 99, Czechia
Offene Rekrutierung
Prof. MUDr. Petr Arenberger, DrSc., MBA, Prague, 11000, Czechia
Offene Rekrutierung
Fakultni nemocnice Bulovka, Prague, 180 81, Czechia
Noch nicht rekrutierend
Hospices Civils de Lyon - CIC - Hopital Louis Pradel, Bron, 69500, France
Offene Rekrutierung
Centre Hospitalier de Dijon Bourgogne - Hôpital François Mitterrand, Dijon, 21000, France
Noch nicht rekrutierend
GHICL - Service d'investigation - Recherche clinique, Lille, 59000, France
Noch nicht rekrutierend
GHICL - Hôpital Saint Vincent de Paul, Lille, 59020, France
Noch nicht rekrutierend
Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2, Nice, 06200, France
Noch nicht rekrutierend
Hopital Enfants Malades Necker, Paris, 75015, France
Noch nicht rekrutierend
Hôpitaux Drôme Nord - Romans, Romans-sur-Isère, 26100, France
Noch nicht rekrutierend
Asst Spedali Civili Di Brescia, Brescia, 25123, Italy
Noch nicht rekrutierend
Miyagi
Tohoku University Hospital, Sendai, Miyagi, 980-8574, Japan
Offene Rekrutierung
Niigata
Niigata University Medical & Dental Hospital, Niigata, Niigata, 951-8520, Japan
Offene Rekrutierung
Shizuoka
Hamamatsu University Hospital, Hamamatsu, Shizuoka, 431-3192, Japan
Offene Rekrutierung
Tokyo
Kyorin University Hospital, Mitaka, Tokyo, 181-8611, Japan
Offene Rekrutierung
Osaka Metropolitan University Hospital, Osaka, 545-8586, Japan
Offene Rekrutierung
Lesser Poland Voivodeship
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski s.c., Krakow, Lesser Poland Voivodeship, 30-002, Poland
Offene Rekrutierung
Lower Silesian Voivodeship
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska, Wroclaw, Lower Silesian Voivodeship, 50-566, Poland
Offene Rekrutierung
Lublin Voivodeship
DERMEDIC Iwona Zdybska, Lublin, Lublin Voivodeship, 20-607, Poland
Offene Rekrutierung
Masovian Voivodeship
Klinika Osipowicz & Turkowski, Warsaw, Masovian Voivodeship, 00-716, Poland
Offene Rekrutierung
Państwowy Instytut Medyczny MSWiA, Warsaw, Masovian Voivodeship, 02-507, Poland
Offene Rekrutierung
Provita Poliklinika, Warsaw, Masovian Voivodeship, 02-647, Poland
Offene Rekrutierung
Klinika Ambroziak Dermatologia, Warsaw, Masovian Voivodeship, 02-953, Poland
Offene Rekrutierung
Royalderm Agnieszka Nawrocka, Warsaw, Masovian Voivodeship, 02-962, Poland
Offene Rekrutierung
Podlaskie Voivodeship
Nzoz Specjalistyczny Ośrodek Dermatologiczny "Dermal", Bialystok, Podlaskie Voivodeship, 15-453, Poland
Offene Rekrutierung
Silesian Voivodeship
Centrum Medyczne Angelius Provita, Katowice, Silesian Voivodeship, 40-611, Poland
Offene Rekrutierung
Labderm Essence Sp. Z o.o., Ossy, Silesian Voivodeship, 42-624, Poland
Noch nicht rekrutierend
Uniwersytecki Szpital kliniczny im. F. Chopina w Rzeszowie, Rzeszów, 35-055, Poland
Noch nicht rekrutierend
Łódź Voivodeship
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak, Lodz, Łódź Voivodeship, 90-436, Poland
Offene Rekrutierung
Hospital Universitario Miguel Servet, Zaragoza, 50009, Spain
Offene Rekrutierung
EAST Sussex
Royal Alexandra Children's Hospital, Brighton, EAST Sussex, BN2 5BE, United Kingdom
Offene Rekrutierung
Greater London
Guy's and St Thomas' NHS Foundation Trust, London, Greater London, SE1 7EH, United Kingdom
Offene Rekrutierung
Chelsea and Westminster Hospital NHS Foundation Trust, London, Greater London, SW10 9NH, United Kingdom
Offene Rekrutierung