Clinical trial • Phase III • Immunology
RITLECITINIB TOSILATE for Alopecia areata
Phase III trial of RITLECITINIB TOSILATE for Alopecia areata. Placebo to match ritlecitinib 50 mg; Placebo to match ritlecitinib 30 mg-controlled.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Alopecia areata
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 07-07-2025
- First CTIS Authorization Date
- 14-10-2025
Trial design
Placebo to match ritlecitinib 50 mg; Placebo to match ritlecitinib 30 mg-controlled Phase III trial across 33 sites in Poland, France, Czechia and others.
- Comparator
- Placebo to match ritlecitinib 50 mg; Placebo to match ritlecitinib 30 mg
- Target Sample Size
- 62
- Trial Duration For Participant
- 1080
Eligibility
Recruits 62 paediatric patients.
- Vulnerable Population
- Pediatric participants are explicitly included. Age-specific informed consent/assent handling is provided: parent/guardian informed consent and separate assent/ICF documents for minors (examples: Minor ICF 6-12; Minor/Assent 13-17; Parent/Guardian ICF). Country-specific ICFs and assent forms are available (documents listed for PL, FR, CZ, ES, IT).
Inclusion criteria
- {"criterion_text":"- a)For participants originating from Study B7981031: 1.Participants with AA (including alopecia totalis [AT] and alopecia universalis [AU]) who completed the B7981031 study.\n- 2.\tAt least 50% scalp hair loss due to AA (ie, a SALT score of ≥50) at both the Screening and Baseline visits.\n- b)For participants originating from Study B7981027: 3.\tParticipants with AA (including AT and AU) who completed the B7981027 study."}
Exclusion criteria
- {"criterion_text":"- a)Exclusion criteria for participants originating from Study B7981027 with ≤ 30 Days between last dose in Study B7981027 and first visit of Study B7981028: 1.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.\n- 2. 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.\n- b)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: 1. 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.\n- 2. Any present malignancies or history of malignancies or lymphoproliferative disorders.\n- 3. Evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection.\n- 4. History (one or more episodes) of severe or serious cytomegalovirus (CMV), herpes zoster (shingles) or disseminated herpes simplex.\n- 5. Any infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant within prior 3 months.\n- 6. Infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- • Incidence of treatment-emergent adverse events (AEs).\n- • Incidence of serious AEs (SAEs) and AEs leading to permanent discontinuation from the study.","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- • Response based on achieving absolute Severity of Alopecia Tool (SALT) score ≤10 at all visits.\n- • Response based on achieving absolute SALT score ≤20 at all visits\n- •\tChange from baseline (CFB) in SALT score at all visits.\n- • Response based on achieving at least 2 grade improvement or a score of 3 in eyebrow assessment (EBA) score at all visits in participants with an abnormal EBA at baseline.\n- • Response based on achieving at least 2 grade improvement or a score of 3 in eyelash assessment (ELA) score at all visits in participants with an abnormal ELA at baseline.\n- • Patient Global Impression of Change (PGI-C) response defined as score of “moderately improved or greatly improved” at all time points.\n- • CFB in Patient Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Depressive Symptoms T-score at all visits.\n- • CFB in PROMIS Parent Proxy Anxiety Symptoms T-score at all visits.\n- • CFB in Behavior Rating Inventory of Executive Function®2 (BRIEF®2) T-scores for the three index scores (Behavior Regulation Index [BRI], Emotional Regulation Index [ERI], Cognitive Regulation Index [CRI]) at all visits.\n- • CFB in modified Children's Dermatology Life Quality Index (CDLQI) total score at all visits.\n- • CFB# in Wechsler Intelligence Scale for Children® Fifth Edition (WISC-V) at end of study (Month 36).","definition_or_measurement_approach":""}
Recruitment
- Registry Or Advocacy Recruitment
- True, Advocacy Group Study Alert (country-specific materials present for PL, FR, CZ, ES, IT; specific organisations not named)
- Digital Remote Recruitment
- True, digital methods include Digital Adverts Pack, Animated Video/Study animation and Media Board materials (country-specific digital/online recruitment materials listed).
- Planned Sample Size
- 62
- Recruitment Window Months
- 48
- Consent Approach
- Informed consent obtained from adult participants; for pediatric participants parent/guardian informed consent required, with separate assent/ICF documents for minors. Age-specific assent/ICF documents are provided (examples: Assent 6-11; Assent 12-17; Parent/Guardian ICF). Country- and language-specific ICFs/assents are provided (documents present in PL, FR, CZ, ES, IT and English versions where noted).
Methods
- Printed materials: study posters, flyers and patient brochures (country-specific versions listed for PL, FR, CZ, ES, IT).
- Advocacy Group alerts / Study alerts (documents titled 'Advocacy Group Study Alert' available for multiple countries) targeted to patient advocacy groups.
- Digital media: Digital Adverts Pack, Animated Video and Study animation (country-specific) for online/digital recruitment.
- Media materials / Media Board (country-specific) for broader outreach.
- Recruitment arrangements documents (K1) describing recruitment procedure at country level (K1 files present for PL, FR, CZ, ES, IT).
Geography
- Total Number Of Sites
- 33
- Total Number Of Participants
- 78
Poland
- Earliest CTIS Part Ii Submission Date
- 10-09-2025
- Latest Decision Or Authorization Date
- 23-12-2025
- Processing Time Days
- 104
- Number Of Sites
- 14
- Number Of Participants
- 31
Sites
- Site Name
- Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.
- Principal Investigator Name
- Jacek Szepietowski
- Principal Investigator Email
- jacek.szepietowski.work@gmail.com
- Contact Person Name
- Jacek Szepietowski
- Contact Person Email
- jacek.szepietowski.work@gmail.com
- Site Name
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
- Department Name
- Klinika Dermatologiczna
- Principal Investigator Name
- Lidia Rudnicka
- Principal Investigator Email
- lidiarudnicka@gmail.com
- Contact Person Name
- Lidia Rudnicka
- Contact Person Email
- lidiarudnicka@gmail.com
- Site Name
- Dermedic Iwona Zdybska
- Principal Investigator Name
- Jacek Zdybski
- Principal Investigator Email
- jacek_z@icloud.com
- Contact Person Name
- Jacek Zdybski
- Contact Person Email
- jacek_z@icloud.com
- Site Name
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
- Department Name
- Klinika Dermatologii
- Principal Investigator Name
- Irena Walecka Herniczek
- Principal Investigator Email
- irena.walecka@cskmswia.gov.pl
- Contact Person Name
- Irena Walecka Herniczek
- Contact Person Email
- irena.walecka@cskmswia.gov.pl
- Site Name
- Royalderm Agnieszka Nawrocka
- Principal Investigator Name
- Witold Owczarek
- Principal Investigator Email
- witold.owczarek@dermedicus.pl
- Contact Person Name
- Witold Owczarek
- Contact Person Email
- witold.owczarek@dermedicus.pl
- Site Name
- Labderm Essence Sp. z o.o.
- Principal Investigator Name
- Beata Bergler-Czop
- Principal Investigator Email
- bbergler-czop@sum.edu.pl
- Contact Person Name
- Beata Bergler-Czop
- Contact Person Email
- bbergler-czop@sum.edu.pl
- Site Name
- Provita Sp. z o.o.
- Principal Investigator Name
- Anita Lewartowska-Bialek
- Principal Investigator Email
- a.bialek@angelius.org
- Contact Person Name
- Anita Lewartowska-Bialek
- Contact Person Email
- a.bialek@angelius.org
- Site Name
- Klinika Ambroziak Sp. z o.o.
- Principal Investigator Name
- Justyna Skibinska
- Principal Investigator Email
- principalskibinska@klinikaambroziak.pl
- Contact Person Name
- Justyna Skibinska
- Contact Person Email
- principalskibinska@klinikaambroziak.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
- Principal Investigator Name
- Adam Reich
- Principal Investigator Email
- adamandrzejreich@gmail.com
- Contact Person Name
- Adam Reich
- Contact Person Email
- adamandrzejreich@gmail.com
- Site Name
- Dermoklinika-Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
- Principal Investigator Name
- Joanna Narbutt
- Principal Investigator Email
- joanna.narbutt@onet.pl
- Contact Person Name
- Joanna Narbutt
- Contact Person Email
- joanna.narbutt@onet.pl
- Site Name
- Provita Poliklinika Sp. z o.o.
- Principal Investigator Name
- Mariusz Sikora
- Principal Investigator Email
- drmariuszsikora@gmail.com
- Contact Person Name
- Mariusz Sikora
- Contact Person Email
- drmariuszsikora@gmail.com
- Site Name
- Specjalistyczny gabinet dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SC
- Principal Investigator Name
- Pawel Brzewski
- Principal Investigator Email
- brzewski@gmail.com
- Contact Person Name
- Pawel Brzewski
- Contact Person Email
- brzewski@gmail.com
- Site Name
- NZOZ Specjalistyczny Osrodek Dermatologiczny ”Dermal”
- Principal Investigator Name
- Adam Wronski
- Principal Investigator Email
- adam.wronski@dermal.pl
- Contact Person Name
- Adam Wronski
- Contact Person Email
- adam.wronski@dermal.pl
- Site Name
- Klinika Osipowicz & Turkowski Sp. z o.o.
- Principal Investigator Name
- Katarzyna Osipowicz
- Principal Investigator Email
- osipowicz.kasia@gmail.com
- Contact Person Name
- Katarzyna Osipowicz
- Contact Person Email
- osipowicz.kasia@gmail.com
France
- Earliest CTIS Part Ii Submission Date
- 12-09-2025
- Latest Decision Or Authorization Date
- 07-01-2026
- Processing Time Days
- 117
- Number Of Sites
- 8
- Number Of Participants
- 15
Sites
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- Service de Dermatologie
- Principal Investigator Name
- Vivien HEBERT
- Principal Investigator Email
- vivien.hebert@chu-rouen.fr
- Contact Person Name
- Vivien HEBERT
- Contact Person Email
- vivien.hebert@chu-rouen.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- service de Dermatologie
- Principal Investigator Name
- Thierry PASSERON
- Principal Investigator Email
- passeron.t@chu-nice.fr
- Contact Person Name
- Thierry PASSERON
- Contact Person Email
- passeron.t@chu-nice.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Service de Dermatologie
- Principal Investigator Name
- Bertille BONNIAUD
- Principal Investigator Email
- bertille.bonniaud@chu-dijon.fr
- Contact Person Name
- Bertille BONNIAUD
- Contact Person Email
- bertille.bonniaud@chu-dijon.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Service de Dermatologie Pedriatrique
- Principal Investigator Name
- Alice PHAN
- Principal Investigator Email
- alice.phan@chu-lyon.fr
- Contact Person Name
- Alice PHAN
- Contact Person Email
- alice.phan@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Service de Dermatologie
- Principal Investigator Name
- Juliette MAZEREEUW_HAUTIER
- Principal Investigator Email
- mazereeuw-hautier.j@chu-toulouse.fr
- Contact Person Name
- Juliette MAZEREEUW_HAUTIER
- Contact Person Email
- mazereeuw-hautier.j@chu-toulouse.fr
- Site Name
- Hopital Necker-Enfants Malades
- Department Name
- Service de Dermatologie
- Principal Investigator Name
- Chrisitine BODEMER
- Principal Investigator Email
- chrisitine.bodemer@aphp.fr
- Contact Person Name
- Chrisitine BODEMER
- Contact Person Email
- chrisitine.bodemer@aphp.fr
- Site Name
- Hopitaux Drome Nord
- Department Name
- Service de Dermatologie
- Principal Investigator Name
- Francois SKOWRON
- Principal Investigator Email
- f.skowron@ch-hdn.fr
- Contact Person Name
- Francois SKOWRON
- Contact Person Email
- f.skowron@ch-hdn.fr
- Site Name
- Groupement Des Hopitaux De L'Institut Catholique De Lille
- Department Name
- Service de Dermatologie
- Principal Investigator Name
- Audrey LASEK
- Principal Investigator Email
- Lasek.Audrey@ghicl.net
- Contact Person Name
- Audrey LASEK
- Contact Person Email
- Lasek.Audrey@ghicl.net
Czechia
- Earliest CTIS Part Ii Submission Date
- 29-08-2025
- Latest Decision Or Authorization Date
- 25-11-2025
- Processing Time Days
- 88
- Number Of Sites
- 4
- Number Of Participants
- 8
Sites
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- Detska nemocnice Detske kozni oddeleni PeK
- Principal Investigator Name
- Blanka Pinkova
- Principal Investigator Email
- pinkova.blanka@fnbrno.cz
- Contact Person Name
- Blanka Pinkova
- Contact Person Email
- pinkova.blanka@fnbrno.cz
- Site Name
- Fakultni Nemocnice Bulovka
- Department Name
- Dermatovenerologicka klinika
- Principal Investigator Name
- Filip Rob
- Principal Investigator Email
- filip.rob@gmail.com
- Contact Person Name
- Filip Rob
- Contact Person Email
- filip.rob@gmail.com
- Site Name
- Fakultni Nemocnice Plzen
- Department Name
- Dermatovenerologicka klinika
- Principal Investigator Name
- Jan Ricar
- Principal Investigator Email
- ricarj@fnplzen.cz
- Contact Person Name
- Jan Ricar
- Contact Person Email
- ricarj@fnplzen.cz
- Site Name
- Prof. MUDr. Petr Arenberger, DrSc., MBA
- Principal Investigator Name
- Monika Arenbergerová
- Principal Investigator Email
- arenbergerova@email.cz
- Contact Person Name
- Monika Arenbergerová
- Contact Person Email
- arenbergerova@email.cz
Spain
- Earliest CTIS Part Ii Submission Date
- 09-09-2025
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 176
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Hospital Sant Joan De Deu Barcelona
- Department Name
- Pediatric Dermatology
- Principal Investigator Name
- Carolina Prat Torres
- Principal Investigator Email
- carolinasusana.prat@sjd.es
- Contact Person Name
- Carolina Prat Torres
- Contact Person Email
- carolinasusana.prat@sjd.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Dermatology
- Principal Investigator Name
- Caridad Elena Morales Múnera
- Principal Investigator Email
- CMorales@santpau.cat
- Contact Person Name
- Caridad Elena Morales Múnera
- Contact Person Email
- CMorales@santpau.cat
- Site Name
- Hospital Universitario Miguel Servet
- Department Name
- Dermatology
- Principal Investigator Name
- Fermina Yolanda Gilaberte Calzada
- Principal Investigator Email
- ygilaberte@salud.aragon.es
- Contact Person Name
- Fermina Yolanda Gilaberte Calzada
- Contact Person Email
- ygilaberte@salud.aragon.es
Italy
- Earliest CTIS Part Ii Submission Date
- 24-04-2025
- Latest Decision Or Authorization Date
- 23-04-2026
- Processing Time Days
- 364
- Number Of Sites
- 4
- Number Of Participants
- 18
Sites
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- UO Dermatologia - IRCCS Policlinico S. Orsola-Malpighi, Bologna
- Principal Investigator Name
- Michela Starace
- Principal Investigator Email
- michela.starace2@unibo.it
- Contact Person Name
- Michela Starace
- Contact Person Email
- michela.starace2@unibo.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
- Department Name
- Azienda Ospedaliero-Universitaria Policlinico “G. Rodolico - San Marco" Di Catania
- Principal Investigator Name
- Giuseppe Micali
- Principal Investigator Email
- gmicalitrial@gmail.com
- Contact Person Name
- Giuseppe Micali
- Contact Person Email
- gmicalitrial@gmail.com
- Site Name
- Azienda Ospedaliera Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- Universita degli Studi della Campania "Luigi Vanvitelli"
- Principal Investigator Name
- Giuseppe Argenziano
- Principal Investigator Email
- g.argenziano@gmail.com
- Contact Person Name
- Giuseppe Argenziano
- Contact Person Email
- g.argenziano@gmail.com
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- ASST Spedali Civili di Brescia
- Principal Investigator Name
- Valeria Boccaletti
- Principal Investigator Email
- valeria.boccaletti@gmail.com
- Contact Person Name
- Valeria Boccaletti
- Contact Person Email
- valeria.boccaletti@gmail.com
Sponsor
Primary sponsor
- Full Name
- Pfizer Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Almac Pharmaceutical Services Pte Ltd
- Responsibilities
- code:14; code:15 (IP Description)
- Name
- Almac Clinical Services LLC
- Responsibilities
- IP Destruction; IP Description (various locations)
- Name
- Syneos Health UK Limited / Syneos Health Inc.
- Responsibilities
- codes:1 and 5 (responsibilities per sponsorDuties entries)
- Name
- Icon Clinical Research Limited
- Responsibilities
- Training
- Name
- Pharmaceutical Product Development LLC (PPD) and affiliated PPD organisations
- Responsibilities
- code:4 (multiple PPD entities listed for site services/lab services)
- Name
- QPS LLC
- Responsibilities
- code:4
- Name
- Signant Health Global LLC
- Responsibilities
- code:7
- Name
- Canfield Scientific Inc.
- Responsibilities
- code:7
Third parties
- {"country":"Singapore","full_name":"Almac Pharmaceutical Services Pte Ltd","duties_or_roles":"code:14; code:15 (IP Description)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"code:15 (Participant Reimbursement)","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United Kingdom","full_name":"Syneos Health UK Limited","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"code:14; code:15 (IP Destruction)","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code:15 (Training)","organisation_type":"Pharmaceutical company"}
- {"country":"China","full_name":"Ppd Laboratories (Suzhou) Co. Ltd.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"Singapore","full_name":"PPD Global Central Labs (S) Pte Ltd","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Services LLC (Durham address)","duties_or_roles":"code:14; code:15 (IP Destruction)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"code:7","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"QPS LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Almac Clinical Services (Ireland) Limited","duties_or_roles":"code:14; code:15 (IP Destruction)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"code:5","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Services LLC (4238 Technology Drive)","duties_or_roles":"code:14; code:15 (IP Description)","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Innovative Trials Limited","duties_or_roles":"code:15 (Recruitment Materials)","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"code:14; code:15 (IP Destruction)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"code:7","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Services LLC (4204 Technology Drive)","duties_or_roles":"code:14; code:15 (IP Description)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Services LLC (4228 Technology Drive)","duties_or_roles":"code:14; code:15 (IP Destruction)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Ritlecitinib tosilate
- Active Substance
- RITLECITINIB TOSILATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Starting Dose
- 50 mg
- Dose Levels
- 50 mg
- Maximum Dose
- 50 mg
- Investigational Product Name
- Ritlecitinib
- Active Substance
- RITLECITINIB TOSILATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Starting Dose
- 30 mg
- Dose Levels
- 30 mg
- Maximum Dose
- 30 mg
- Investigational Product Name
- Placebo to match ritlecitinib 50 mg
- Modality
- Other
- Investigational Product Name
- Placebo to match ritlecitinib 30 mg
- Modality
- Other
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