Clinical trial NCT05723198: A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
Official title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of Baricitinib in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Areata Alopecia
Alopecia
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-02-10
Enrollment: 595
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to determine the efficacy and safety of baricitinib for the treatment of severe or very severe alopecia areata (hair loss) in children from 6 years to less than 18 years of age.

The study is divided into 4 periods, a 5-week Screening period, a 36-week Double-Blind Treatment Period, an approximately 2-year Long-term Extension Period, and a 4-week Post-treatment Follow-up period.


Eligibility criteria: Inclusion Criteria:

* Enrollment will be fully sequential by age group, with adolescents (12 to less than 18 years old) enrolling before children (6 to less than 12 years old).
* Have severe areata alopecia (AA) for at least 1 year
* Diagnosis for at least 1 year
* Current AA episode of at least 6 months' duration
* SALT score ≥50% at screening and baseline
* History of trial and failure with at least 1 available treatment (topical or other) for AA
* History of psychological counseling related to AA
* Current episode of severe AA of less than 8 years.

  * Note: Participants who have severe AA for ≥8 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 8 years.

Exclusion Criteria:

* Primarily "diffuse" type of AA (characterized by diffuse hair shedding).
* Are currently experiencing other forms of alopecia including, but not limited to trichotillomania, telogen effluvium, chemotherapy-induced hair loss, or any other concomitant conditions (for example, tinea capitis, psoriasis, lupus erythematosus, or secondary syphilis) that would interfere with evaluations of the effect of study medication on AA.
* Are largely or wholly incapacitated permitting little or no self-care, such as being bedridden
* Have uncontrolled arterial hypertension
* Have had major surgery within 8 weeks prior to screening or will require major surgery during the study
* Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking IP or interfere with the interpretation of data.
* Have a positive test for hepatitis B virus (HBV) infection
* Have hepatitis C virus (HCV) infection (positive for anti hepatitis C antibody with confirmed presence of HCV ribonucleic acid \[RNA\]).
* Have evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies.

Primary outcomes:
measure: Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) ≤20
timeFrame: Week 36
Secondary outcomes:
measure: Percent Change from Baseline in SALT Score
timeFrame: Baseline, Week 36
measure: Percentage of Participants Achieving At Least 90% Improvement from Baseline (SALT90)
timeFrame: Week 36
measure: Percentage of Participants Achieving an Absolute SALT ≤10
timeFrame: Week 36
measure: Percentage of Participants with Patient Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 Among Participants 12 Years and Older with PRO for Scalp Hair Assessment Score ≥3 at Baseline
timeFrame: Week 36
measure: Mean Change from Baseline in SALT Score
timeFrame: Baseline, Week 36
measure: Percentage of Participants Achieving At Least 50% Improvement from Baseline (SALT50)
timeFrame: Week 36
measure: Percentage of Participants Achieving At Least 75% Improvement from Baseline (SALT75)
timeFrame: Week 36
measure: Percentage of Participants Achieving At Least 100% Improvement from Baseline (SALT100)
timeFrame: Week 36
measure: Percentage of Participants Achieving Clinician-Reported Outcome (ClinRO) Measure for Eyebrow (EB) Hair Loss 0 or 1 Among Participants with CLinRO Measure for EB Hair Loss ≥2 at Baseline
timeFrame: Week 36
measure: Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 Among Participants with CLinRO Measure for EL Hair Loss ≥2 at Baseline
timeFrame: Week 36
measure: Percentage of Participants Achieving PRO Measure for EB 0 or 1 (Among Participants 12 Years or Older with PRO Measure for EB ≥2 at Baseline)
timeFrame: Week 36
measure: Percentage of Participants Achieving PRO Measure for EL 0 or 1 (Among Participants 12 Years or Older with PRO Measure for EL ≥2 at Baseline)
timeFrame: Week 36
measure: Mean Change from Baseline in Hospital Anxiety Depression Scale (HADS)
timeFrame: Week 36
measure: Mean Change from Baseline in Patient-Reported Outcome Measurement Information System (PROMIS) Anxiety Score
timeFrame: Baseline, Week 36
measure: Mean Change from Baseline in PROMIS Depression Score
timeFrame: Baseline, Week 36
measure: Mean Change from Baseline in PROMIS Peer Relationship Score
timeFrame: Baseline, Week 36
measure: Mean Change from Baseline in Family Dermatology Life Quality Index (FDLQI)
timeFrame: Baseline, Week 36
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax)
timeFrame: Baseline through Week 36
measure: PK: Area Under the Concentration Curve (AUC)
timeFrame: Baseline through Week 36
measure: Change of Immunoglobulin G (IgG) Titers
timeFrame: Pre-Vaccination to 4 Weeks and 12 Weeks Post-Vaccination
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center, PC
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Scottsdale
country: United States
facility: Investigate MD
state: Arizona
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: San Diego
country: United States
facility: University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology
state: California
city: San Francisco
country: United States
facility: The Permanente Medical Group, Inc.
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology, Inc.
state: California
city: Fairfield
country: United States
facility: Dermatology Physicians of Connecticut
state: Connecticut
city: Boca Raton
country: United States
facility: Skin Care Research, Inc
state: Florida
city: Coral Gables
country: United States
facility: Florida Academic Centers Research and Education, LLC
state: Florida
city: Coral Gables
country: United States
facility: Pediatric Skin Research, LLC
state: Florida
city: Doral
country: United States
facility: D&H Doral Research Center LLC
state: Florida
city: Hollywood
country: United States
facility: Skin Care Research, Inc
state: Florida
city: Jacksonville
country: United States
facility: Solutions Through Advanced Research, Inc.
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Macon
country: United States
facility: Skin Care Physicians of Georgia
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Skokie
country: United States
facility: Northshore University Healthsystem
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: South Bend
country: United States
facility: The South Bend Clinic Center for Research
state: Indiana
city: Rockville
country: United States
facility: DermAssociates PC.
state: Maryland
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Clarkston
country: United States
facility: Michigan Center for Research Company
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical School
state: Minnesota
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: Omaha
country: United States
facility: Advanced Skin Research Center
state: Nebraska
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Charlotte
country: United States
facility: Dermatology Specialists of Charlotte
state: North Carolina
city: Charlotte
country: United States
facility: OnSite Clinical Solutions
state: North Carolina
city: Bexley
country: United States
facility: Bexley Dermatology Research
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, P.C.
state: Oklahoma
city: Portland
country: United States
facility: Northwest Dermatology Institute
state: Oregon
city: Exton
country: United States
facility: The Pennsylvania Centre for Dermatology, LLC
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Murfreesboro
country: United States
facility: International Clinical Research - Tennessee (IC Research)
state: Tennessee
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center
state: Texas
city: Grapevine
country: United States
facility: Pediatric Dermatology of North Texas
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Sugar Land
country: United States
facility: Complete Dermatology
state: Texas
city: Murray
country: United States
facility: University of Utah MidValley Dematology
state: Utah
city: Norfolk
country: United States
facility: Virginia Clinical Research
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
city: Caba
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
state: Buenos Aires
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Buenos Aires Skin
state: Buenos Aires
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Instituto de Neumonología Y Dermatología
state: Buenos Aires
city: Pilar
country: Argentina
facility: Hospital Universitario Austral
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Fundación Respirar
state: Buenos Air
city: San Miguel de Tucuman
country: Argentina
facility: Hospital del Niño Jesus
state: Provincia De Tucuman
city: SAN M. DE Tucuman
country: Argentina
facility: Centro Medico Privado de Reumatologia
state: Tucumán
city: Buenos Aires
country: Argentina
facility: Psoriahue Medicina Interdisciplinaria
city: Darlinghurst
country: Australia
facility: Skin and Cancer Foundation Australia - Darlinghurst Clinic
state: New South Wales
city: Saint Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Wooloongabba
country: Australia
facility: Veracity Clinical Research Pty Ltd
state: Queensland
city: Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
city: Mitcham
country: Australia
facility: Institute for Skin, Health, and Immunity
state: Victoria
city: Calgary
country: Canada
facility: Dermatology Research Institute
state: Alberta
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc.
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: Cobourg
country: Canada
facility: Skin Health
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Toronto
country: Canada
facility: Research Toronto
state: Ontario
city: Brest CEDEX 2
country: France
facility: CHRU de Brest - Hôpital Morvan
city: Marseille
country: France
facility: AP-HM CHU Timone - Pharmacie Secteur Essais Cliniques
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
city: Paris
country: France
facility: Centre de Sante Sabouraud
city: Tours Cedex
country: France
facility: Hôpital Clocheville Chru-Tours Département Dermatologie
city: München
country: Germany
facility: Klinikum Rechts der Isar der TU München
state: Bayern
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
state: Niedersachsen
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
state: Sachsen
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
city: Halle
country: Germany
facility: Universitätsklinik und Poliklinik für Dermatologie und Venerologie
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Kath. Kinderkrankenhaus Wilhelmstift
city: Mainz
country: Germany
facility: Dermatologische Gemeinschaftspraxis Dres. Quist
city: Muenster
country: Germany
facility: University of Muenster, Dept. of Dermatology, Central Study Coordination for innovative Dermatology
city: Kaposvar
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktato Korhaz
state: Somogy
city: Budapest
country: Hungary
facility: Clinexpert Kft.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem
city: Szeged
country: Hungary
facility: Univerisity of Szeged
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Miyagi-gun
country: Japan
facility: Rifu Dermatology Allergy Clinic
state: Miyagi
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
city: Mitaka
country: Japan
facility: Kyorin University Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Ube
country: Japan
facility: Yamaguchi University Hospital
state: Yamaguchi
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Cheonan-si
country: Korea, Republic of
facility: Dankook University Hospital
state: Chungcheongnam-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Geonggi-do
city: Suwon-City
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggido
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
state: Incheon-gwangyeoksi [Incheon]
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
state: Pusan-Kwangyǒkshi
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Hospital at Gangdong
state: Seoul, Korea
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Jung-gu
country: Korea, Republic of
facility: Kyungpook National University Hospital
state: Taegu-Kwangyǒkshi
city: Daejeon
country: Korea, Republic of
facility: Chungnam national university hospital
city: Jeonju-si
country: Korea, Republic of
facility: Jeonbuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University College of Medicine - Chung-Ang University Hospital (CAUH)
city: Guadalajara
country: Mexico
facility: Grupo Clínico CATEI SC
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez
state: NL
city: Monterrey
country: Mexico
facility: Eukarya PharmaSite
state: Nuevo León
city: Chihuahua
country: Mexico
facility: Hospital Angeles Chihuahua Unidad de Investigacion Clinica
city: Mexico City
country: Mexico
facility: Innovacion y Desarrollo de Estrategias en Salud SA de CV
city: Mexico City
country: Mexico
facility: Mexico Centre for Clinical Research
city: Veracruz
country: Mexico
facility: Arké SMO S.A de C.V
city: Lodz
country: Poland
facility: Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
state: Lodzkie
city: Krakow
country: Poland
facility: Specjalistyczny Gabinet Dermatologiczny s.c.
state: Malopolskie
city: Warsaw
country: Poland
facility: High-Med Przychodnia Specjalistyczna
state: Masovian
city: Rzeszow
country: Poland
facility: Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie
state: Podkarpackie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o.
state: Pomorskie
city: Bialystok
country: Poland
facility: NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL
city: Bydgoszcz
country: Poland
facility: Medicover Integrated Clinical Services (MICS) Centrum Medyczne Bydgoszcz
city: Katowice
country: Poland
facility: CareClinic
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
city: Kielce
country: Poland
facility: Gabinet Dermatologiczny
city: Swietokrzyski
country: Poland
facility: DERMEDIC Jacek Zdybski
city: Szczecin
country: Poland
facility: Laser Clinic Dermatologia Laserowa Medycyna Estetyczna
city: Warszawa
country: Poland
facility: Provita Poliklinika Sp. z o.o.
city: Warszawa
country: Poland
facility: Royalderm Agnieszka Nawrocka
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSWiA
city: Warszawa
country: Poland
facility: Centrum Medyczne Evimed
city: Warszawa
country: Poland
facility: Klinika Ambroziak Sp. Z.O.O.
city: Wroclaw
country: Poland
facility: CityClinic Przychodnia Lekarsko-Psychologiczna
city: Barcelona
country: Spain
facility: Parc de Salut Mar - Hospital del Mar
state: Catalunya [Cataluña]
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quironsalud Madrid
state: Madrid
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
city: Bilbao (Bizkaia)
country: Spain
facility: Hospital Universitario Basurto
city: Madrid
country: Spain
facility: Clinica Pedro Jaen
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor-INTERNAL MED
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
state: New Taipei
city: Taichung City
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: