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Eine Studie mit 2 Dosen Ritlecitinib bei Menschen ab 12 Jahren mit Alopezie Areata (ALLEGRO-100)

16. Oktober 2026 aktualisiert von: Pfizer

A Phase 3, externe und synthetische, placebokontrollierte randomisierte Studie mit Dosis für Nicht-Responder

The purpose of the study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the treatment of alopecia areata. Alopecia areata is a disease that causes hair loss on the scalp, face, and areas of the body.

Ritlecitinib is approved in many countries at a dose of 50 mg (milligram) taken by mouth once a day for the treatment of patients 12 years and older with severe alopecia areata. This study will look at both the 50 mg dose and a 100 mg dose.

This study is seeking participants who:

  • Are 12 years of age or older (Part 1)
  • Are 12 to less than 18 years (Part 2)
  • Have a diagnosis of alopecia areata
  • Have lost 50% or more of the hair on their scalp
  • Do not have any other conditions that causes hair loss
  • Are willing to stop all other treatments that they may be taking for alopecia areata

About 550 participants will take part in Part 1 of this study. About 80 participants will take part in Part 2 of this study.

In Part 1, participants will be chosen by chance, like drawing names out of a hat, to receive 1 of 2 different amounts of ritlecitinib (50 mg and 100 mg) taken by mouth once daily.

The 2 doses of ritlecitinib in this study will be compared to each other and also to data from previous studies. This will help to see if the 100 mg dose of ritlecitinib is safe and effective.

In Part 2, all eligible participants will receive ritlecitinib 100 mg taken by mouth once daily. The data from this part of the study will be combined with the data from Part 1 of the study to help to see if the 100 mg dose of ritlecitinib is safe and effective in adolescent patients with alopecia areata.

People will be in this study for about 13 months. During the study, participants will need to visit the study site up to 9 times. Participants will undergo various tests and procedures such as:

  • alopecia areata assessment,
  • physical examinations,
  • hearing tests,
  • blood tests,
  • x-ray,
  • ECG (electrocardiogram),
  • photographs of the scalp and eyes (Part 1 only). Participants will also be asked to complete questionnaires about their alopecia areata.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

674

Phase

  • Phase 3

Erweiterter Zugriff

Verfügbar außerhalb der klinischen Studie. Siehe erweiterter Zugriffsdatensatz.

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
      • Beijing, China, 100050
        • Aktiv, nicht rekrutierend
        • Beijing Friendship hospital, Capital Medical University
      • Beijing, China, 100730
        • Aktiv, nicht rekrutierend
        • Beijing Tongren Hospital affiliated to Capital Medical University
      • Nanjing, China, 210029
        • Aktiv, nicht rekrutierend
        • Nanjing Medical University (NMU) - Jiangsu Province Hospital
      • Shanghai, China, 200062
        • Rekrutierung
        • Shanghai Children's Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100029
        • Aktiv, nicht rekrutierend
        • China-Japan Friendship Hospital
      • Beijing, Beijing Municipality, China, 100044
        • Aktiv, nicht rekrutierend
        • Peking University People's Hospital
      • Beijing, Beijing Municipality, China, 100192
        • Aktiv, nicht rekrutierend
        • China-Japan Friendship Hospital
      • Beijing, Beijing Municipality, China, 100032
        • Aktiv, nicht rekrutierend
        • Beijing Children's hospital, Capital Medical University
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400010
        • Aktiv, nicht rekrutierend
        • The Second Affiliated Hospital Chongqing Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Aktiv, nicht rekrutierend
        • The First Affiliated Hospital of Guangzhou Medical University
      • Guangzhou, Guangdong, China, 510140
        • Aktiv, nicht rekrutierend
        • The First Affiliated Hospital of Guangzhou Medical University
    • Hunan
      • Changsha, Hunan, China, 410008
        • Aktiv, nicht rekrutierend
        • Xiangya Hospital Central South University
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Aktiv, nicht rekrutierend
        • Jiangxi Provincial Children's Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200040
        • Aktiv, nicht rekrutierend
        • Huashan Hospital, Fudan University
    • Sichuan
      • Chengdu, Sichuan, China, 610017
        • Aktiv, nicht rekrutierend
        • Chengdu second people's hospital
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Aktiv, nicht rekrutierend
        • First Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Rekrutierung
        • Hangzhou Third Hospital
      • Hangzhou, Zhejiang, China, 310016
        • Aktiv, nicht rekrutierend
        • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
  • Japan
      • Osaka, Japan, 545-8586
        • Aktiv, nicht rekrutierend
        • Osaka Metropolitan University Hospital
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Aktiv, nicht rekrutierend
        • Kurume University Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Aktiv, nicht rekrutierend
        • Tohoku University Hospital
    • Niigata
      • Niigata, Niigata, Japan, 951-8520
        • Aktiv, nicht rekrutierend
        • Niigata University Medical & Dental Hospital
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Rekrutierung
        • Hamamatsu University Hospital
    • Tokyo
      • Koto-ku, Tokyo, Japan, 136-0075
        • Rekrutierung
        • Juntendo Tokyo Koto Geriatric Medical Center
      • Mitaka, Tokyo, Japan, 181-8611
        • Rekrutierung
        • Kyorin University Hospital
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Rekrutierung
        • Tokyo Medical University Hospital
  • Kanada
      • Québec, Kanada, G1V 3V9
        • Aktiv, nicht rekrutierend
        • Centre de Recherche Saint-Louis
      • Québec, Kanada, G1V 4X7
        • Aktiv, nicht rekrutierend
        • Centre de Recherche Dermatologique du Quebec metropolitain
      • Québec, Kanada, G1W 4R4
        • Aktiv, nicht rekrutierend
        • Centre de Recherche Saint-Louis inc.
    • Alberta
      • Calgary, Alberta, Kanada, T2J 7E1
        • Aktiv, nicht rekrutierend
        • Dermatology Research Institute
      • Red Deer, Alberta, Kanada, T4P 1K4
        • Aktiv, nicht rekrutierend
        • CaRe Clinic
    • Manitoba
      • Winnipeg, Manitoba, Kanada, R3M 3Z4
        • Aktiv, nicht rekrutierend
        • Wiseman Dermatology Research Inc.
    • Ontario
      • Barrie, Ontario, Kanada, L4M 7G1
        • Aktiv, nicht rekrutierend
        • SimcoDerm Medical and Surgical Dermatology Center
      • Guelph, Ontario, Kanada, N1L 0B7
        • Aktiv, nicht rekrutierend
        • Guelph Dermatology Research
      • London, Ontario, Kanada, N6H 5L5
        • Aktiv, nicht rekrutierend
        • DermEffects
      • Markham, Ontario, Kanada, L3P 1X3
        • Aktiv, nicht rekrutierend
        • Lynderm Research Inc.
      • Newmarket, Ontario, Kanada, L3Y 5G8
        • Aktiv, nicht rekrutierend
        • Ryan Clinical Research Inc.
      • Oakville, Ontario, Kanada, L6J 7W5
        • Aktiv, nicht rekrutierend
        • The Centre for Clinical Trials
      • Ottawa, Ontario, Kanada, K1K 4L2
        • Aktiv, nicht rekrutierend
        • JRB Research Inc.
      • Peterborough, Ontario, Kanada, K9J 5K2
        • Aktiv, nicht rekrutierend
        • SKiN Centre for Dermatology
      • Toronto, Ontario, Kanada, M4W 2N4
        • Aktiv, nicht rekrutierend
        • Dermatology on Bloor - Research Toronto
    • Quebec
      • Montreal, Quebec, Kanada, H2X 2V1
        • Aktiv, nicht rekrutierend
        • Innovaderm Research Inc.
      • Montreal, Quebec, Kanada, H1Y 3L1
        • Aktiv, nicht rekrutierend
        • Centre de Recherche Saint-Louis
      • Sherbrooke, Quebec, Kanada, J1G 1X9
        • Aktiv, nicht rekrutierend
        • Centre de Recherche Saint-Louis
  • Polen
      • Gdansk, Polen, 80-546
        • Aktiv, nicht rekrutierend
        • Penta Hospitals Badania Kliniczne sp. z o.o.
      • Ostrowiec Świętokrzyski, Polen, 27-400
        • Aktiv, nicht rekrutierend
        • DERMEDIC Iwona Zdybska
      • Warsaw, Polen, 00-124
        • Aktiv, nicht rekrutierend
        • NZOZ GynCentrum - Oddział Warszawa
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Polen, 60-324
        • Aktiv, nicht rekrutierend
        • Twoja Przychodnia PCM
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Polen, 30-002
        • Aktiv, nicht rekrutierend
        • Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski spółka
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Polen, 50-566
        • Aktiv, nicht rekrutierend
        • Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Polen, 20-607
        • Aktiv, nicht rekrutierend
        • DERMEDIC Iwona Zdybska
    • Lubusz Voivodeship
      • Nowa Sól, Lubusz Voivodeship, Polen, 67-100
        • Aktiv, nicht rekrutierend
        • Twoja Przychodnia NCM
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polen, 00-716
        • Aktiv, nicht rekrutierend
        • Klinika Osipowicz & Turkowski
      • Warsaw, Masovian Voivodeship, Polen, 01-018
        • Aktiv, nicht rekrutierend
        • Dr Sękowska Leczenie Bólu
      • Warsaw, Masovian Voivodeship, Polen, 02-962
        • Aktiv, nicht rekrutierend
        • Royalderm Agnieszka Nawrocka
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Polen, 40-611
        • Aktiv, nicht rekrutierend
        • Centrum Medyczne Angelius Provita
      • Sosnowiec, Silesian Voivodeship, Polen, 41-200
        • Aktiv, nicht rekrutierend
        • Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Polen, 71-500
        • Aktiv, nicht rekrutierend
        • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Puerto Rico
      • San Juan, Puerto Rico, 00917
        • Aktiv, nicht rekrutierend
        • GCM Medical Group, PSC - Hato Rey Site
  • Spanien
      • Madrid, Spanien, 28006
        • Aktiv, nicht rekrutierend
        • Grupo Pedro Jaén
      • Madrid, Spanien, 28006
        • Aktiv, nicht rekrutierend
        • Resonancia Magnetica Nuestra Senora del Rosario
      • Zaragoza, Spanien, 50009
        • Aktiv, nicht rekrutierend
        • Hospital Universitario Miguel Servet
    • A Coruña [LA Coruña]
      • Santiago de Compostela, A Coruña [LA Coruña], Spanien, 15706
        • Aktiv, nicht rekrutierend
        • CHUS - Hospital Clinico Universitario
    • Andalusia
      • Córdoba, Andalusia, Spanien, 14001
        • Aktiv, nicht rekrutierend
        • AUDIKA
      • Córdoba, Andalusia, Spanien, 14004
        • Aktiv, nicht rekrutierend
        • Hospital Universitario Reina Sofia
  • Südkorea
      • Seoul, Südkorea, 07061
        • Rekrutierung
        • Seoul Metropolitan Government Seoul National University Boramae Medical Center Laboratory
    • Chungcheongnam-do [chungnam]
      • Cheonan-si, Chungcheongnam-do [chungnam], Südkorea, 31116
        • Rekrutierung
        • Dankook University Hospital
    • Jeonrabugdo
      • Jeonju, Jeonrabugdo, Südkorea, 54907
        • Rekrutierung
        • Jeonbuk National University Hospital
    • Kyǒnggi-do
      • Seongnam, Kyǒnggi-do, Südkorea, 13620
        • Aktiv, nicht rekrutierend
        • Seoul National University Bundang Hospital
    • Pusan-kwangyǒkshi
      • Busan, Pusan-kwangyǒkshi, Südkorea, 49241
        • Rekrutierung
        • Pusan National University Hospital
    • Seoul-teukbyeolsi [seoul]
      • Seoul, Seoul-teukbyeolsi [seoul], Südkorea, 03080
        • Aktiv, nicht rekrutierend
        • Seoul National University Hospital
      • Seoul, Seoul-teukbyeolsi [seoul], Südkorea, 05030
        • Rekrutierung
        • Konkuk University Medical Center
      • Seoul, Seoul-teukbyeolsi [seoul], Südkorea, 03312
        • Aktiv, nicht rekrutierend
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
      • Seoul, Seoul-teukbyeolsi [seoul], Südkorea, 05278
        • Aktiv, nicht rekrutierend
        • Kyung Hee University Hospital at Gangdong
    • Taegu-kwangyǒkshi
      • Daegu, Taegu-kwangyǒkshi, Südkorea, 41944
        • Aktiv, nicht rekrutierend
        • Kyungpook National University Hospital
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • Aktiv, nicht rekrutierend
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taipei, Taiwan, 11217
        • Aktiv, nicht rekrutierend
        • Taipei Veterans General Hospital
      • Taoyuan, Taiwan, 333
        • Aktiv, nicht rekrutierend
        • Chang Gung Medical Foundation-Linkou Branch
    • Kaohsiung
      • Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
        • Aktiv, nicht rekrutierend
        • Chang Gung Memorial Hospital at Kaohsiung
  • Tschechien
      • Pardubice, Tschechien, 53002
        • Aktiv, nicht rekrutierend
        • Pratia Czech s.r.o.
    • Plzeň Region
      • Pilsen, Plzeň Region, Tschechien, 301 00
        • Aktiv, nicht rekrutierend
        • Fakultni Nemocnice Plzen
    • Praha 6
      • Prague, Praha 6, Tschechien, 160 00
        • Aktiv, nicht rekrutierend
        • Kozni ambulance Fialova s.r.o
  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten, 35233
        • Rekrutierung
        • University of Alabama at Birmingham
      • Birmingham, Alabama, Vereinigte Staaten, 35233
        • Rekrutierung
        • The Kirklin Clinic of UAB Hospital (Radiology)
      • Birmingham, Alabama, Vereinigte Staaten, 35233
        • Rekrutierung
        • University of Alabama at Birmingham Faculty Office Towers (Regulatory)
    • Arkansas
      • Hot Springs, Arkansas, Vereinigte Staaten, 71913
        • Aktiv, nicht rekrutierend
        • Burke Pharmaceutical Research
    • California
      • Brea, California, Vereinigte Staaten, 92821
        • Rekrutierung
        • Doc1 Healthcare Systems
      • Encinitas, California, Vereinigte Staaten, 92024
        • Aktiv, nicht rekrutierend
        • California Dermatology & Clinical Research Institute
      • Huntington Beach, California, Vereinigte Staaten, 92647
        • Aktiv, nicht rekrutierend
        • Marvel Clinical Research
      • Irvine, California, Vereinigte Staaten, 92617
        • Rekrutierung
        • University of California - Irvine
      • Irvine, California, Vereinigte Staaten, 92697
        • Rekrutierung
        • Gavin Herbert Eye Institute
      • Santa Ana, California, Vereinigte Staaten, 92701
        • Aktiv, nicht rekrutierend
        • Southern California Clinical Research
    • Connecticut
      • Fairfield, Connecticut, Vereinigte Staaten, 06824
        • Rekrutierung
        • Brett King MD, LLC
    • Florida
      • Fort Myers, Florida, Vereinigte Staaten, 33912
        • Aktiv, nicht rekrutierend
        • Alliance for Multispecialty Research, LLC
      • Fort Myers, Florida, Vereinigte Staaten, 33912
        • Aktiv, nicht rekrutierend
        • Robert B. Pritt, DO, PA
      • Miami, Florida, Vereinigte Staaten, 33173
        • Rekrutierung
        • Skin Research of South Florida
      • Miami, Florida, Vereinigte Staaten, 33156
        • Rekrutierung
        • Pediatric Skin Research
      • Tampa, Florida, Vereinigte Staaten, 33613
        • Aktiv, nicht rekrutierend
        • ForCare Clinical Research
      • Tampa, Florida, Vereinigte Staaten, 33615
        • Aktiv, nicht rekrutierend
        • Olympian Clinical Research - Tampa - Memorial Highway
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60625
        • Rekrutierung
        • Endeavor Health Audiology -CHICAGO
      • Lake Bluff, Illinois, Vereinigte Staaten, 60044
        • Rekrutierung
        • Endeavor Health Audiology -LAKE BLUFF
      • Northbrook, Illinois, Vereinigte Staaten, 60062
        • Rekrutierung
        • Endeavor Health Audiology-NORTHBROOK
      • Skokie, Illinois, Vereinigte Staaten, 60077
        • Rekrutierung
        • Endeavor Health
      • Skokie, Illinois, Vereinigte Staaten, 60076
        • Rekrutierung
        • Endeavor Health Audiology-SKOKIE
      • Skokie, Illinois, Vereinigte Staaten, 60077
        • Rekrutierung
        • Endeavor Health Imaging & Radiology Serviccs - Old Orchard
      • Skokie, Illinois, Vereinigte Staaten, 60077
        • Rekrutierung
        • Endeavor Health Lab Services - Old Orchard
    • Indiana
      • Indianapolis, Indiana, Vereinigte Staaten, 46250
        • Rekrutierung
        • Dawes Fretzin Clinical Research Group, LLC
    • Iowa
      • Iowa City, Iowa, Vereinigte Staaten, 52242
        • Rekrutierung
        • University of Iowa
    • Maryland
      • Baltimore, Maryland, Vereinigte Staaten, 21218
        • Rekrutierung
        • Johns Hopkins University
      • Glenn Dale, Maryland, Vereinigte Staaten, 20769
        • Aktiv, nicht rekrutierend
        • Callender Center for Clinical Research
      • Rockville, Maryland, Vereinigte Staaten, 20850
        • Rekrutierung
        • Dermatology and Skin Cancer Specialists, LLC
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02114
        • Aktiv, nicht rekrutierend
        • Massachusetts General Hospital
      • Boston, Massachusetts, Vereinigte Staaten, 02111
        • Aktiv, nicht rekrutierend
        • Tufts Medical Center
      • Boston, Massachusetts, Vereinigte Staaten, 02114
        • Aktiv, nicht rekrutierend
        • The General Hospital Corporation d/b/a Massachusetts General Hospital
    • Michigan
      • Troy, Michigan, Vereinigte Staaten, 48084
        • Aktiv, nicht rekrutierend
        • Revival Research Institute, LLC
    • Minnesota
      • Minneapolis, Minnesota, Vereinigte Staaten, 55455
        • Rekrutierung
        • University of Minnesota Health Clinical Research Unit (M Health CRU)
      • Minneapolis, Minnesota, Vereinigte Staaten, 55454
        • Rekrutierung
        • University of Minnesota Clinics and Surgery Center Department of Radiology
      • Minneapolis, Minnesota, Vereinigte Staaten, 55455
        • Rekrutierung
        • University of Minnesota Clinics and Surgery Center Department of Audiology
      • Minneapolis, Minnesota, Vereinigte Staaten, 55455
        • Rekrutierung
        • University of Minnesota Clinics and Surgery Center Department of Radiology
    • New York
      • New York, New York, Vereinigte Staaten, 10029
        • Rekrutierung
        • Icahn School of Medicine at Mount Sinai
    • North Carolina
      • Chapel Hill, North Carolina, Vereinigte Staaten, 27516
        • Aktiv, nicht rekrutierend
        • UNC Dermatology and Skin Cancer Center
      • Chapel Hill, North Carolina, Vereinigte Staaten, 27599
        • Aktiv, nicht rekrutierend
        • Clinical & Translational Research Center (CTRC)
      • Charlotte, North Carolina, Vereinigte Staaten, 28211
        • Aktiv, nicht rekrutierend
        • DJL Clinical Research, PLLC
    • Ohio
      • Bexley, Ohio, Vereinigte Staaten, 43209
        • Rekrutierung
        • Bexley Dermatology Research
      • Canton, Ohio, Vereinigte Staaten, 44718
        • Aktiv, nicht rekrutierend
        • Apex Clinical Research Center - Canton
    • Oklahoma
      • Tulsa, Oklahoma, Vereinigte Staaten, 74136
        • Rekrutierung
        • Vital Prospects Clinical Research Institute, PC
    • Oregon
      • Portland, Oregon, Vereinigte Staaten, 97201
        • Aktiv, nicht rekrutierend
        • Oregon Medical Research Center
      • Portland, Oregon, Vereinigte Staaten, 97210
        • Aktiv, nicht rekrutierend
        • Northwest Dermatology Institute
      • Portland, Oregon, Vereinigte Staaten, 97210
        • Aktiv, nicht rekrutierend
        • NW Dermatology Institute
    • Pennsylvania
      • Plymouth Meeting, Pennsylvania, Vereinigte Staaten, 19462
        • Aktiv, nicht rekrutierend
        • Dermatology Associates of Plymouth Meeting
    • South Carolina
      • Charleston, South Carolina, Vereinigte Staaten, 29425
        • Aktiv, nicht rekrutierend
        • Medical University of South Carolina - South Carolina Translational Research Nexus Clinic
      • Myrtle Beach, South Carolina, Vereinigte Staaten, 29588
        • Aktiv, nicht rekrutierend
        • Alliance for Multispecialty Research, LLC
    • Texas
      • Arlington, Texas, Vereinigte Staaten, 76011
        • Aktiv, nicht rekrutierend
        • Arlington Research Center
      • Bellaire, Texas, Vereinigte Staaten, 77401
        • Noch keine Rekrutierung
        • The University of Texas Health Science Center at Houston
      • Dallas, Texas, Vereinigte Staaten, 75230
        • Aktiv, nicht rekrutierend
        • Dermatology Treatment and Research Center
      • Houston, Texas, Vereinigte Staaten, 77004
        • Rekrutierung
        • Center for Clinical Studies
      • San Antonio, Texas, Vereinigte Staaten, 78218
        • Rekrutierung
        • Texas Dermatology and Laser Specialists
      • Webster, Texas, Vereinigte Staaten, 77598
        • Rekrutierung
        • Center for Clinical Studies - Clear Lake
    • Utah
      • Layton, Utah, Vereinigte Staaten, 84041
        • Aktiv, nicht rekrutierend
        • AMR Clinical
      • Murray, Utah, Vereinigte Staaten, 84107
        • Aktiv, nicht rekrutierend
        • University of Utah
    • Washington
      • Spokane, Washington, Vereinigte Staaten, 99202
        • Aktiv, nicht rekrutierend
        • Dermatology Specialists of Spokane
      • Spokane, Washington, Vereinigte Staaten, 99202
        • Aktiv, nicht rekrutierend
        • Principle Research Solutions
  • Vereinigtes Königreich
      • London, Vereinigtes Königreich, SE1 7EH
        • Aktiv, nicht rekrutierend
        • Guy's & St Thomas' NHS Foundation Trust
    • Brighton AND HOVE
      • East Sussex, Brighton AND HOVE, Vereinigtes Königreich, BN2 1ES
        • Aktiv, nicht rekrutierend
        • University Hospitals Sussex NHS Foundation Trust
    • Dundee CITY
      • Dundee, Dundee CITY, Vereinigtes Königreich, DD1 9SY
        • Aktiv, nicht rekrutierend
        • Ninewells Hospital and Medical School
    • England
      • London, England, Vereinigtes Königreich, SW10 9NH
        • Aktiv, nicht rekrutierend
        • Chelsea and Westminster Hospital NHS Foundation Trust
    • London, CITY of
      • London, London, CITY of, Vereinigtes Königreich, SE1 9RT
        • Aktiv, nicht rekrutierend
        • Guy's & St Thomas' NHS Foundation Trust
    • WEST Sussex
      • Worthing, WEST Sussex, Vereinigtes Königreich, BN11 2DH
        • Aktiv, nicht rekrutierend
        • University Hospitals Sussex NHS Foundation Trust

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

12 Jahre und älter (Kind, Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

Age:

  1. 18 years of age or older at screening. Adolescents (12 to <18 years of age at screening) are also eligible for this study, but only if permitted by the local IRB/EC and local regulatory health authority (if applicable). Where these approvals have not been granted, only participants 18 years of age and older at screening will be enrolled. In Part 2 of the study, only adolescents (12 to <18 years of age at both Screening and Day 1) who did not participate in Part 1 will be enrolled.

    Disease Characteristics:

  2. Must meet the following alopecia areata criteria at both Screening and Baseline:

    1. Have a clinical diagnosis of alopecia areata with no other etiology of hair loss.
    2. ≥50% hair loss of the scalp, as measured by SALT, without evidence of terminal hair regrowth within the previous 6 months.
    3. Current episode of hair loss ≤10 years.

Exclusion Criteria:

Medical Conditions:

  1. Diseases or conditions other than alopecia areata which affect hair loss, including other types of alopecia, other scalp disease that may impact the alopecia areata assessment, or active systemic diseases that may cause hair loss.

  2. History of severe allergic or anaphylactoid reaction to any kinase inhibitor or a known allergy/hypersensitivity to any component (including excipients) of the study intervention.

  3. Any psychiatric condition including recent or active suicidal ideation or behavior that meets protocol-defined criteria.

  4. General Infection History:

    • Have a history of systemic infection requiring hospitalization or parenteral therapy (antimicrobial, antiviral, antiparasitic, antiprotozoal, or antifungal), or as otherwise judged clinically significant by the investigator, within 3 months prior to Day 1.
    • Have active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 1. NOTE: participants may be rescreened after the infection resolves.
    • Evidence or history of untreated, currently treated or inadequately treated active or latent infection with Mycobacterium tuberculosis.

  5. Specific Viral Infection History:

    • History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.
    • Infected with hepatitis B or hepatitis C viruses: all participants will undergo screening for hepatitis B and C for eligibility.

  6. Other Medical Conditions:

    • Have hearing loss with progression over the previous 5 years, sudden hearing loss, or middle or inner ear disease such as otitis media, cholesteatoma, Meniere's disease, labyrinthitis, or other auditory condition that is considered acute, fluctuating or progressive.
    • Abnormal findings on the screening chest imaging (eg, chest x-ray) including, but not limited to, presence of active TB or other infections, cardiomyopathy, or malignancy. Chest imaging may be performed up to 12 weeks prior to Screening.
    • Have any malignancies or have a history of malignancies with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
    • Have a history of any lymphoproliferative disorder such as EBV-related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
    • Significant trauma or major surgery within 1 month of the first dose of study drug or considered in imminent need for surgery.

  7. Adolescent participants 12 to <18 years of age without one of the following:

    • Documented evidence from a health professional 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 IgG Ab result) at Screening.

  8. Any medical or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

    Prior/Concomitant Therapy:

  9. Current or prior use of any prohibited medication(s), vaccine(s), or treatment(s) within the protocol-defined timelines.

    Prior/Concurrent Clinical Study Experience:

  10. Previous administration with an investigational drug or vaccine within 8 weeks (or longer as determined by the local requirement) or 5 half-lives (whichever is longer) before the first dose of study intervention in this study. Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study. Receipt of study intervention in Study B7981094 or other studies of ritlecitinib.

    Diagnostic Assessments:

  11. Any exclusionary abnormalities in laboratory values at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat.

  12. Screening standard 12-lead ECG that demonstrates clinically relevant abnormalities.

    Other Exclusion Criteria:

  13. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Ritlecitinib 50 mg

Participants in Part 1 will be randomized to Ritlecitinib 50 mg QD for 24 weeks. Depending on response status at Week 24 (ie, whether the participant has a SALT score of less than or equal to 20), the participant may be re-randomized to Ritlecitinib 50 mg QD or Ritlecitinib 100 mg QD for another 24 weeks. Data from participants who are non-responders (ie, had a SALT score greater than 20) at Week 24 and re-randomized to Ritlecitinib 50 mg will be augmented with data from an External Ritlecitinib 50 mg QD Group for comparisons at Week 48. The External Ritlecitinib 50 mg QD Group will be constructed using patient-level data from the appropriately chosen Pfizer clinical study in participants who received Ritlecitinib 50 mg QD and were non-responders at Week 24 and continued receiving ritlecitinib 50 mg QD up to Week 48.

In addition to the active Ritlecitinib 50 mg capsule, a placebo capsule matching the Ritlecitinib 100 mg capsule will be given in order to maintain the blind.
Arzneimittel: Ritlecitinib 50 mg

50 mg Capsule

Andere Namen:
  • PF-06651600
  • Litfulo
Arzneimittel: Placebo - 100 mg

Capsule (to match Ritlecitinib 100 mg)
Kein Eingriff: External Placebo

This group will be constructed using participant-level data at Week 24 from placebo groups of the appropriately chosen Pfizer clinical studies of Ritlecitinib in participants with alopecia areata. This data will be used for comparison between each Ritlecitinib dose and placebo at Week 24.

As this arm will utilize data from other studies, no participants will be randomized to receive only placebo in this study.
Experimental: Ritlecitinib 100 mg (open-label)

Participants in Part 2 will be assigned to receive one open-label Ritlecitinib 100 mg capsule once daily by mouth for 48 weeks.
Arzneimittel: Ritlecitinib 100 mg

100 mg Capsule

Andere Namen:
  • PF-06651600
  • Litfulo
Experimental: Ritlecitinib 100 mg

Participants in Part 1 will be randomized to Ritlecitinib 100 mg QD for 48 weeks.

In addition to the active Ritlecitinib 100 mg capsule, a placebo capsule matching the Ritlecitinib 50 mg capsule will be given in order to maintain the blind.
Arzneimittel: Ritlecitinib 100 mg

100 mg Capsule

Andere Namen:
  • PF-06651600
  • Litfulo
Arzneimittel: Placebo - 50 mg

Capsule (to match Ritlecitinib 50 mg)
Kein Eingriff: Synthetic Placebo

This group will be constructed using participant-level data up to Week 36 from the placebo groups of the appropriately chosen Pfizer clinical studies of Ritlecitinib in participants with alopecia areata and a longitudinal model and extrapolation. This data will be used for comparison between Ritlecitinib 100 mg and placebo at Week 36.

As this arm will utilize data from other studies, no participants will be randomized to receive only placebo in this study.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Part 1: Percentage of participants with absolute Severity of Alopecia Tool (SALT) score less than or equal to 20
Zeitfenster: Week 24

Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 100 mg once-daily (QD) versus placebo
Week 24
Part 2: Percentage of participants with TEAEs, SAEs, and AEs leading to discontinuation
Zeitfenster: Baseline to Follow-up visit (Week 52)

Percentage of participants with events, based on those reported in the study including the safety follow-up period for ritlecitinib 100 mg QD
Baseline to Follow-up visit (Week 52)
Part 2: Percentage of participants with clinically significant laboratory abnormalities
Zeitfenster: Baseline to Follow-up visit (Week 52)

Percentage of participants with clinically significant laboratory abnormalities, based on those reported in the study including the safety follow-up period for ritlecitinib 100 mg QD
Baseline to Follow-up visit (Week 52)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Part 1: Percentage of participants with absolute SALT score less than or equal to 20
Zeitfenster: Week 24

Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 50 mg QD versus placebo
Week 24
Part 1: EU Only: Percentage of participants with Patient Global Impression of Change (PGI-C) response, defined as a score of "moderately improved" or "greatly improved"
Zeitfenster: Week 24

Difference in percentage of participants with PGI-C response between ritlecitinib 100 mg QD versus placebo and ritlecitinib 50 mg QD versus placebo
Week 24
Part 1: US Only: Percentage of participants with absolute SALT score less than or equal to 20
Zeitfenster: Week 36

Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 100 mg QD versus placebo
Week 36
Part 1: Change from baseline in SALT score
Zeitfenster: Week 24

Difference in the mean absolute change from baseline in SALT score between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD
Week 24
Part 1: Percentage of participants with absolute SALT score equal to 0
Zeitfenster: Week 24

Difference in the percentage of participants with SALT score equal to 0 between ritlecitinib 100 mg QD versus placebo and ritlecitinib 50 mg QD versus placebo
Week 24
Part 1: Percentage of participants with absolute SALT score less than or equal to 10
Zeitfenster: Baseline through Week 24

Difference in the percentage of participants with SALT score less than or equal to 10 between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD
Baseline through Week 24
Part 1: Percentage of participants with absolute SALT score less than or equal to 20
Zeitfenster: Baseline through Week 24

Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD
Baseline through Week 24
Part 1: Percentage of participants with absolute SALT score equal to 0
Zeitfenster: Baseline through Week 24

Difference in the percentage of participants with SALT score equal to 0 between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD
Baseline through Week 24
Part 1: Change from baseline in SALT score
Zeitfenster: Baseline through Week 24

Difference in the mean absolute change from baseline in SALT score between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD
Baseline through Week 24
Part 1: Percentage of participants with EBA (Eyebrow Assessment) response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal EBA score at baseline)
Zeitfenster: Baseline through Week 24

Difference in the percentage of participants with EBA response (among participants without a normal EBA score at baseline) between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD
Baseline through Week 24
Part 1: Percentage of participants with ELA (Eyelash Assessment) response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal ELA score at baseline)
Zeitfenster: Baseline through Week 24

Difference in the percentage of participants with ELA response (among participants without a normal ELA score at baseline) between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD
Baseline through Week 24
Part 1: Percentage of participants with PGI-C response, defined as a score of "moderately improved" or "greatly improved"
Zeitfenster: Baseline through Week 24

Difference in the percentage of participants with PGI-C response between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD
Baseline through Week 24
Part 1: Percentage of participants with absolute SALT score less than or equal to 10
Zeitfenster: Week 24

Difference in the percentage of participants with SALT score less than or equal to 10 between ritlecitinib 100 mg QD versus placebo and ritlecitinib 50 mg QD versus placebo
Week 24
Part 1: Percentage of participants with EBA response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal EBA score at baseline)
Zeitfenster: Week 24

Difference in the percentage of participants with EBA response (among participants without a normal EBA score at baseline) between ritlecitinib 100 mg QD versus placebo and ritlecitinib 50 mg QD versus placebo
Week 24
Part 1: Percentage of participants with ELA response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal ELA score at baseline)
Zeitfenster: Week 24

Difference in the percentage of participants with ELA response (among participants without a normal ELA score at baseline) between ritlecitinib 100 mg QD versus placebo and ritlecitinib 50 mg QD versus placebo
Week 24
Part 1: Percentage of participants with absolute SALT score less than or equal to 20
Zeitfenster: Week 48

Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 50 mg non-responder (NR)-->ritlecitinib 100 mg QD versus ritlecitinib 50 mg NR-->ritlecitinib 50 mg QD
Week 48
Part 1: Percentage of participants with absolute SALT score less than or equal to 10
Zeitfenster: Week 48

Difference in the percentage of participants with SALT score less than or equal to 10 between ritlecitinib 50 mg NR-->ritlecitinib 100 mg QD versus ritlecitinib 50 mg NR-->ritlecitinib 50 mg QD
Week 48
Part 1: Change from Week 24 in SALT score
Zeitfenster: Week 48

Difference in the mean absolute change from Week 24 in SALT score between ritlecitinib 50 mg NR-->ritlecitinib 100 mg QD versus ritlecitinib 50 mg NR-->ritlecitinib 50 mg QD
Week 48
Part 1: Percentage of participants with PGI-C response, defined as a score of "moderately improved" or "greatly improved"
Zeitfenster: Week 48

Percentage of participants with PGI-C response between ritlecitinib 50 mg NR-->ritlecitinib 100 mg QD versus ritlecitinib 50 mg NR-->ritlecitinib 50 mg QD
Week 48
Part 1: Percentage of participants with absolute SALT score less than or equal to 20
Zeitfenster: Week 24 through Week 48

Percentage of participants with SALT score less than or equal to 20 for ritlecitinib 100 mg QD, ritlecitinib 50 mg responder (R)-->50 mg QD, ritlecitinib 50 mg NR-->50 mg QD, and ritlecitinib 50 mg NR-->100 mg QD
Week 24 through Week 48
Part 1: Percentage of participants with absolute SALT score less than or equal to 10
Zeitfenster: Week 24 through Week 48

Percentage of participants with SALT score less than or equal to 10 for ritlecitinib 100 mg QD, ritlecitinib 50 mg R-->50 mg QD, ritlecitinib 50 mg NR-->50 mg QD, and ritlecitinib 50 mg NR-->100 mg QD
Week 24 through Week 48
Part 1: Percentage of participants with absolute SALT score equal to 0
Zeitfenster: Week 24 through Week 48

Percentage of participants with SALT score equal to 0 for ritlecitinib 100 mg QD, ritlecitinib 50 mg R-->50 mg QD, ritlecitinib 50 mg NR-->50 mg QD, and ritlecitinib 50 mg NR-->100 mg QD
Week 24 through Week 48
Part 1: Change from Week 24 in SALT score
Zeitfenster: Week 24 through Week 48

Mean absolute change from Week 24 in SALT score for ritlecitinib 100 mg QD, ritlecitinib 50 mg R-->50 mg QD, ritlecitinib 50 mg NR-->50 mg QD, and ritlecitinib 50 mg NR-->100 mg QD
Week 24 through Week 48
Part 1: Percentage of participants with EBA response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal EBA score at baseline)
Zeitfenster: Week 24 through Week 48

Percentage of participants with EBA response for ritlecitinib 100 mg QD, ritlecitinib 50 mg R-->50 mg QD, ritlecitinib 50 mg NR-->50 mg QD, and ritlecitinib 50 mg NR-->100 mg QD
Week 24 through Week 48
Part 1: Percentage of participants with ELA response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal ELA score at baseline)
Zeitfenster: Week 24 through Week 48

Percentage of participants with ELA response for ritlecitinib 100 mg QD, ritlecitinib 50 mg R-->50 mg QD, ritlecitinib 50 mg NR-->50 mg QD, and ritlecitinib 50 mg NR-->100 mg QD
Week 24 through Week 48
Part 1: Percentage of participants with PGI-C response, defined as a score of "moderately improved" or "greatly improved"
Zeitfenster: Week 24 through Week 48

Percentage of participants with PGI-C response for ritlecitinib 100 mg QD, ritlecitinib 50 mg R-->50 mg QD, ritlecitinib 50 mg NR-->50 mg QD, and ritlecitinib 50 mg NR-->100 mg QD
Week 24 through Week 48
Part 2: Percentage of participants with absolute SALT score less than or equal to 20
Zeitfenster: Baseline through Week 48

Percentage of participants with absolute SALT score less than or equal to 20 for ritlecitinib 100 mg QD
Baseline through Week 48
Part 2: Percentage of participants with absolute SALT score less than or equal to 10
Zeitfenster: Baseline through Week 48

Percentage of participants with absolute SALT score less than or equal to 10 for ritlecitinib 100 mg QD
Baseline through Week 48
Part 2: Percentage of participants with absolute SALT score equal to 0
Zeitfenster: Baseline through Week 48

Percentage of participants with absolute SALT score equal to 0 for ritlecitinib 100 mg QD
Baseline through Week 48
Part 2: Change from baseline in SALT score
Zeitfenster: Baseline through Week 48

Mean change from baseline in SALT score for ritlecitinib 100 mg QD
Baseline through Week 48
Part 2: Percentage of participants with EBA (Eyebrow Assessment) response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal EBA score at baseline)
Zeitfenster: Baseline through Week 48

Percentage of participants with EBA response for ritlecitinib 100 mg QD
Baseline through Week 48
Part 2: Percentage of participants with ELA (Eyelash Assessment) response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal ELA score at baseline)
Zeitfenster: Baseline through Week 48

Percentage of participants with ELA response for ritlecitinib 100 mg QD
Baseline through Week 48
Part 2: Percentage of participants with PGI-C response, defined as a score of "moderately improved" or "greatly improved"
Zeitfenster: Baseline through Week 48

Percentage of participants with PGI-C response for ritlecitinib 100 mg QD
Baseline through Week 48
Part 1: Percentage of participants with TEAEs, SAEs, and AEs leading to discontinuation
Zeitfenster: Baseline to Follow-up visit (Week 52)

Percentage of participants with events, based on those reported in the study including the safety follow-up period for ritlecitinib 100 mg QD and ritlecitinib 50 mg
Baseline to Follow-up visit (Week 52)
Part 1: Percentage of participants with clinically significant laboratory abnormalities
Zeitfenster: Baseline to Follow-up visit (Week 52)

Percentage of participants with clinically significant laboratory abnormalities, based on those reported in the study including the safety follow-up period for ritlecitinib 100 mg QD and ritlecitinib 50 mg
Baseline to Follow-up visit (Week 52)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Pfizer

Ermittler

  • Studienleiter: Pfizer CT.gov Call Center, Pfizer

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. April 2025

Primärer Abschluss (Geschätzt)

19. März 2028

Studienabschluss (Geschätzt)

19. März 2028

Studienanmeldedaten

Zuerst eingereicht

7. März 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. März 2025

Zuerst gepostet (Tatsächlich)

13. März 2025

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. Oktober 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • B7981094
  • 2024-519370-40-00 (Registrierungskennung: CTIS (EU))

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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