Clinical trial • Phase III • Immunology | Dermatology
RITLECITINIB TOSILATE for Alopecia areata
Phase III trial of RITLECITINIB TOSILATE for Alopecia areata.
Overview
- Trial Therapeutic Area
- Immunology | Dermatology
- Trial Disease
- Alopecia areata
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 25-06-2025
- First CTIS Authorization Date
- 14-10-2025
Trial design
Randomised, placebo to match ritlecitinib 50 mg; placebo to match ritlecitinib 30 mg-controlled Phase III trial across 33 sites in Czechia, France, Italy and others.
- Randomised
- Yes
- Comparator
- Placebo to match ritlecitinib 50 mg; Placebo to match ritlecitinib 30 mg
- Target Sample Size
- 157
- Trial Duration For Participant
- 730
Eligibility
Recruits 157 paediatric patients.
- Vulnerable Population
- Pediatric population selected. The trial enrolls children aged 6 to <12 years. Informed consent is obtained from the parent/legal guardian and age‑appropriate assent is obtained from child participants using specific assent forms (examples of documents listed: 'L1_1_ICF Main_Parent', 'L2_1_ICF_Assent 6-11', 'L3_1_EU Privacy Supplement Notice', country-specific assent/ICF documents are provided for France, Italy, Poland, Spain and Czechia).
Inclusion criteria
- {"criterion_text":"- Participants who are 6 to <12 years old at the time of the screening visit.\n- A diagnosis of AA (including AT and AU) with at least 50% scalp hair loss due to AA (ie, a SALT score of ≥50) at both the screening and baseline visits, without evidence of terminal hair regrowth within the previous 12 months.\n- History of clinical response failure to AA treatment (such as topical, off-label pharmacologic, or hairpiece prosthetics)"}
Exclusion criteria
- {"criterion_text":"- Other (non-AA) types of alopecia; any present or history of malignancies or lymphoproliferative disorders; evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection; history (one or more episodes) of severe or serious cytomegalovirus (CMV) infection, herpes zoster (shingles) or disseminated herpes simplex; history of any infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant within prior 3 months; infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Response based on achieving an absolute SALT score ≤10 at Week 24.","definition_or_measurement_approach":"SALT score (Severity of Alopecia Tool) assessed at Week 24; response defined as achieving an absolute SALT score ≤10 at Week 24."}
Secondary endpoints
- {"endpoint_text":"- PGI‑C response defined as a score of “moderately improved” or “greatly improved” at Week 24.","definition_or_measurement_approach":"Patient's Global Impression of Change (PGI‑C) assessed at Week 24; response defined as 'moderately improved' or 'greatly improved'."}
- {"endpoint_text":"- •\tChange from baseline (CFB) in SALT score at all visits. •\tResponse based on achieving absolute SALT score ≤10 at all visits (except for that included as the primary endpoint). •\tResponse based on achieving absolute SALT score ≤20 at all visits (except for that included as the primary endpoint).","definition_or_measurement_approach":"CFB = change from baseline in SALT at each visit; binary responses defined by absolute SALT thresholds ≤10 and ≤20 at all visits (excluding the primary endpoint visit where specified)."}
- {"endpoint_text":"- PGI-C response at all visits (except for that included as a key secondary endpoint).","definition_or_measurement_approach":"PGI‑C measured at each visit; assessed as response/non-response across visits (excluding the key secondary timepoint)."}
- {"endpoint_text":"- •Response based on improvement from baseline for each AAPPO Item (11 endpoints). •CFB in AAPPO activity limitation and emotional symptoms scores at all visits. •\tCFB in PROMIS Parent Proxy Depressive Symptoms T-score at all visits.","definition_or_measurement_approach":"AAPPO item-level improvement from baseline; change from baseline in AAPPO domain scores and PROMIS Parent Proxy Depressive Symptoms T-score measured at all visits."}
- {"endpoint_text":"- •CFB in PROMIS Parent Proxy Anxiety Symptoms T-score at all visits. •CFB in BRIEF®2 T-scores for the 3 index scores (Behavior Regulation Index [BRI], Emotional Regulation Index [ERI], Cognitive Regulation Index [CRI]) at all visits. •CFB in modified CDLQI total score at all visits.","definition_or_measurement_approach":"Change from baseline in PROMIS Parent Proxy Anxiety T-score, BRIEF®2 index T-scores, and modified CDLQI total score measured at each visit."}
- {"endpoint_text":"- •\tResponse based on achieving at least 2 grade improvement or a score of 3 in EBA score at all visits in participants with an abnormal EBA at baseline.","definition_or_measurement_approach":"Eyebrow Assessment (EBA) response defined as ≥2-grade improvement or score of 3 at visits for participants with abnormal baseline EBA."}
- {"endpoint_text":"- Response based on achieving at least 2 grade improvement or a score of 3 in ELA score at all visits in participants with an abnormal ELA at baseline.","definition_or_measurement_approach":"Eyelash Assessment (ELA) response defined as ≥2-grade improvement or score of 3 at visits for participants with abnormal baseline ELA."}
- {"endpoint_text":"- Plasma concentration of ritlecitinib at 1 hr (±15 min) and 3 hr (±30 min) post-dose at Week 4 or Week 8.","definition_or_measurement_approach":"PK sampling: plasma ritlecitinib concentration measured at ~1 hr (±15 min) and ~3 hr (±30 min) post-dose at Week 4 or Week 8."}
- {"endpoint_text":"- •Incidence of treatment-emergent adverse events (AEs) (including audiological and neurological treatment-emergent AEs). •Incidence of serious AEs (SAEs) and AEs leading to permanent discontinuation from the study.","definition_or_measurement_approach":"Safety endpoints: incidence counts and rates of TEAEs, SAEs, and AEs leading to permanent discontinuation; includes specified audiological and neurological events."}
- {"endpoint_text":"- Acceptability and palatability assessment.","definition_or_measurement_approach":"Assessment of acceptability and palatability of the age‑appropriate formulation (methods/ratings as per protocol)."}
Recruitment
- Registry Or Advocacy Recruitment
- True: 'Advocacy Group Alert' documents present for multiple countries (specific group names not provided in the public documents list).
- Digital Remote Recruitment
- True: digital adverts pack and animated video materials are included (country-specific digital adverts/animated video documents for IT, PL, ES and others).
- Planned Sample Size
- 157
- Recruitment Window Months
- 22
- Consent Approach
- Consent is obtained from parent/legal guardian (parent ICF documents listed, e.g. 'L1_1_ICF Main_Parent' and country-specific parent ICFs). Child assent is obtained with age-appropriate assent forms (e.g. 'L2_1_ICF_Assent 6-11', 'L3_1_ICF_Assent 12-14', and other country-specific assent documents). Subject information and consent materials are provided per country (documents exist in Czech, French, Italian, Polish, Spanish and English versions where applicable) and include an EU privacy supplement.
Methods
- Posters (country-specific recruitment materials present: e.g. K2_Recruitment Material_Poster for CZ/FR/IT/PL/ES).
- Flyers (country-specific recruitment flyers present).
- Patient brochures (country-specific patient brochure documents).
- Animated videos (country-specific 'Animated Video' recruitment materials listed).
- Digital adverts pack (documented for Italy, Poland, Spain: 'Digital Adverts Pack'/'Digital Adverts Pack_B7981027_IT/PL/ES').
- Advocacy group alerts (documents titled 'Advocacy Group Alert' present for multiple countries).
- Recruitment arrangements documentation (country-specific K1 recruitment arrangements files).
Geography
- Total Number Of Sites
- 33
- Total Number Of Participants
- 68
Czechia
- Earliest CTIS Part Ii Submission Date
- 11-09-2025
- Latest Decision Or Authorization Date
- 19-11-2025
- Processing Time Days
- 69
- 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 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
- 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
France
- Earliest CTIS Part Ii Submission Date
- 15-09-2025
- Latest Decision Or Authorization Date
- 21-11-2025
- Processing Time Days
- 67
- Number Of Sites
- 8
- Number Of Participants
- 15
Sites
- 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 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
- Assistance Publique Hopitaux De Paris
- 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
- 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
- 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 Dijon
- Department Name
- Service de Dermatologie
- Principal Investigator Name
- Bertille Bonnieaud
- Principal Investigator Email
- bertille.bonniaud@chu-dijon.fr
- Contact Person Name
- Bertille Bonnieaud
- Contact Person Email
- bertille.bonniaud@chu-dijon.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
- 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
Italy
- Earliest CTIS Part Ii Submission Date
- 07-07-2025
- Latest Decision Or Authorization Date
- 30-01-2026
- Processing Time Days
- 207
- Number Of Sites
- 4
- Number Of Participants
- 8
Sites
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- UOC Dermatologia
- 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 Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- UOC Clinica Dermatologica
- 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
- UO Dermatologia
- Principal Investigator Name
- Valeria Boccaletti
- Principal Investigator Email
- valeria.boccaletti@gmail.com
- Contact Person Name
- Valeria Boccaletti
- Contact Person Email
- valeria.boccaletti@gmail.com
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
- Department Name
- UOC Dermatologia
- Principal Investigator Name
- Giuseppe Micali
- Principal Investigator Email
- gmicalitrial@gmail.com
- Contact Person Name
- Giuseppe Micali
- Contact Person Email
- gmicalitrial@gmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 12-09-2025
- Latest Decision Or Authorization Date
- 05-12-2025
- Processing Time Days
- 84
- Number Of Sites
- 14
- Number Of Participants
- 31
Sites
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Site Name
- Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski, Paweł Brzewski S.C.
- Principal Investigator Name
- Pawel Brzewski
- Principal Investigator Email
- brzewski@gmail.com
- Contact Person Name
- Pawel Brzewski
- Contact Person Email
- brzewski@gmail.com
- 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
- 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
- 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
- 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
Spain
- Earliest CTIS Part Ii Submission Date
- 10-09-2025
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 194
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Dermatology
- Principal Investigator Name
- Caridad Elena Morales Munera
- Principal Investigator Email
- CMorales@santpau.cat
- Contact Person Name
- Caridad Elena Morales Munera
- 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
- 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
Sponsor
Primary sponsor
- Full Name
- Pfizer Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Syneos Health Inc.
- Responsibilities
- Operational CRO/vendor (sponsorDuties code: 5)
- Name
- PPD International Holdings LLC / Pharmaceutical Product Development LLC / Ppd Laboratories (Suzhou) Co. Ltd. / PPD Global Central Labs
- Responsibilities
- Clinical operations / central lab services / vendor activities (sponsorDuties codes: 4 and lab services)
- Name
- Icon Clinical Research Limited
- Responsibilities
- Training and clinical operations support (sponsorDuties code: 15; value: Training)
- Name
- QPS LLC
- Responsibilities
- Vendor/operational support (sponsorDuties code: 4)
Third parties
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: 5","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Almac Clinical Services (Ireland) Limited","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"sponsorDuties codes: 15 (Participant Reimbursement)","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"China","full_name":"Ppd Laboratories (Suzhou) Co. Ltd.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
- {"country":"Singapore","full_name":"PPD Global Central Labs (S) Pte Ltd","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Services LLC (alternate address)","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Services LLC (25 Fretz Road)","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: 15 (Training)","organisation_type":"Pharmaceutical company"}
- {"country":"Singapore","full_name":"Almac Pharmaceutical Services Pte Ltd","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Services LLC (4204 Technology Drive)","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Innovative Trials Limited","duties_or_roles":"sponsorDuties codes: 15 (Recruitment Materials)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"QPS LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"York Bioanalytical Solutions Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Syneos Health UK Limited","duties_or_roles":"sponsorDuties codes: 1","organisation_type":"Pharmaceutical company"}
- {"country":"","full_name":"Other vendor/partner entries (various Almac/PPD/PPD labs/Almac affiliates)","duties_or_roles":"Multiple operational/vendor roles (laboratory, clinical supply, regulatory, etc.) as listed (codes 4,7,14,15, etc.).","organisation_type":"Various"}
Investigational products
- Investigational Product Name
- Ritlecitinib tosilate
- Active Substance
- RITLECITINIB TOSILATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorized product records exist in productDictionary (prodAuthStatus:1) for EU entries
- 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
- Authorized product records exist in productDictionary (prodAuthStatus:1) for EU entries
- 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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