Clinical trial • Phase III • Immunology

UPADACITINIB for Non-segmental vitiligo

Phase III trial of UPADACITINIB for Non-segmental vitiligo.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Non-segmental vitiligo
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
21-11-2023
First CTIS Authorization Date
26-03-2024

Trial design

Randomised, active: upadacitinib 15 mg modified-release tablet, oral; once daily (as stated). comparator arm: upadacitinib placebo (placebo tablet).-controlled Phase III trial in Hungary, Bulgaria, Belgium and others.

Randomised
Yes
Comparator
Active: Upadacitinib 15 mg modified-release tablet, oral; once daily (as stated). Comparator arm: Upadacitinib Placebo (placebo tablet).
Target Sample Size
381
Trial Duration For Participant
336

Eligibility

Recruits 381 paediatric patients.

Pregnancy Exclusion
Pregnancy testing in female subjects of childbearing potential • Females of childbearing potential must not have a positive serum pregnancy test at the Screening Visit and must have a negative urine pregnancy test at Baseline prior to the first dose of study drug (local practices may require serum pregnancy testing at Baseline). • Subjects with a borderline serum pregnancy test at Screening must have absence of clinical suspicion of pregnancy or other pathological causes of borderline results and a serum pregnancy test ≥ 3 days later to document continued lack of a positive result (unless prohibited by local requirements). • Subjects with a urine pregnancy test at Baseline that is borderline or ambiguous must have a serum pregnancy test
Vulnerable Population
Vulnerable population considerations: adolescents (≥12 to <18 years) are included. Informed consent must be obtained (adult participants) and assent for minors is required as per applicable regulation; parental or legally authorized guardian consent is required for minors. The protocol requires consent/assent documents approved by an IEC/IRB; country-specific parent/guardian and assent ICFs are provided (multiple languages) and there are provisions for legally authorized representatives where required by local regulations.

Inclusion criteria

  • {"criterion_text":"- Subjects or their legally authorized representative (if required per local regulations) must be able to understand and be willing to adhere to all protocol requirements and voluntarily sign and date an informed consent (and assent for minors as required by applicable regulation), approved by an IEC/IRB, prior to the initiation of any screening or study-specific procedures.\n- Adult and adolescent individuals, ≥ 12 years of age at Screening.\n- Body weight must be ≥ 30 kg at Baseline Visit for subjects who are ≥ 12 and < 18 years of age.\n- Documented clinical diagnosis of NSV.\n- At Screening and Baseline Visits, subject must satisfy at least 1 of the following criteria: ·\t≥ 0.5 F-VASI and 5 ≤ T-VASI < 50 AND have failed at least 1 topical corticosteroid and/or at least 1 topical calcineurin inhibitor for vitiligo; or ·\t≥ 0.5 F-VASI and 5 ≤ T-VASI < 50 AND have a sign of actively progressing vitiligo; or ·\t≥ 0.5 F-VASI and 10 ≤ T-VASI < 50.\n- Subject is judged to be in good health as determined by the Principal Investigator, based upon the results of the Screening assessments and medical history.\n- Pregnancy testing in female subjects of childbearing potential • Females of childbearing potential must not have a positive serum pregnancy test at the Screening Visit and must have a negative urine pregnancy test at Baseline prior to the first dose of study drug (local practices may require serum pregnancy testing at Baseline). • Subjects with a borderline serum pregnancy test at Screening must have absence of clinical suspicion of pregnancy or other pathological causes of borderline results and a serum pregnancy test ≥ 3 days later to document continued lack of a positive result (unless prohibited by local requirements). • Subjects with a urine pregnancy test at Baseline that is borderline or ambiguous must have a serum pregnancy test"}

Exclusion criteria

  • {"criterion_text":"- Subject has segmental or localized vitiligo.\n- Subject has been treated with any permanent skin bleaching agents.\n- Subject has a history of active skin disease other than vitiligo that could interfere with the assessment of vitiligo.\n- Subject must not have > 33% leukotrichia in areas of vitiligo on the face or > 33% leukotrichia in areas of vitiligo on the body (including the face).\n- Subject has current or past history of any of the following infections: •Two or more episodes of herpes zoster, or one or more episodes or disseminated herpes zoster; • One or more episodes of disseminated herpes simplex (including eczema herpeticum); • Human immunodeficiency virus infection defined as confirmed positive anti-HIV antibody test; • Active TB or meet TB exclusionary parameters (specific requirements for TB testing will be provided in the Operations Manual [Appendix F]);\n- Subject has evidence of: • HBV • HCV\n- There must be no reason the investigator believes that the subject is an unsuitable candidate to participate in the study, receive study drug, or would be placed at risk by participating in the study.\n- Subject must not have a history of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.\n- The investigator believes that the subject is an unsuitable candidate to participate in the study, receive study drug, or would be placed at risk by participating in the study.\n- Subject has been treated with any systemic JAK inhibitor."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Achievement of T-VASI 50 (≥ 50% reduction in T-VASI from Baseline) at Week 48","definition_or_measurement_approach":"T-VASI 50 defined as ≥50% reduction in T-VASI from Baseline measured at Week 48."}
  • {"endpoint_text":"- Achievement of F-VASI 75 (≥ 75% reduction in F-VASI from Baseline) at Week 48","definition_or_measurement_approach":"F-VASI 75 defined as ≥75% reduction in F-VASI from Baseline measured at Week 48."}

Secondary endpoints

  • {"endpoint_text":"- Achievement of F-VASI 50 (≥ 50% reduction in F-VASI from Baseline) at Week 48;","definition_or_measurement_approach":"F-VASI 50: ≥50% reduction in F-VASI from Baseline at Week 48."}
  • {"endpoint_text":"- Achievement of F-VASI 75 (≥ 75% reduction in F-VASI from Baseline) at Week 24;","definition_or_measurement_approach":"F-VASI 75 at Week 24: ≥75% reduction in F-VASI from Baseline at Week 24."}
  • {"endpoint_text":"- Percent change from Baseline in F-VASI at Week 24;","definition_or_measurement_approach":"Percent change from Baseline in F-VASI measured at Week 24."}
  • {"endpoint_text":"- Percent change from Baseline in T-VASI at Week 48;","definition_or_measurement_approach":"Percent change from Baseline in T-VASI measured at Week 48."}
  • {"endpoint_text":"- Achievement of F-VASI 90 (≥ 90% reduction in F-VASI from Baseline) at Week 48;","definition_or_measurement_approach":"F-VASI 90: ≥90% reduction in F-VASI from Baseline at Week 48."}
  • {"endpoint_text":"- Achievement of VNS score of \"A lot less noticeable (4)\" or \"No longer noticeable (5)\" at Week 48;","definition_or_measurement_approach":"VNS patient/visual noticeability score measured at Week 48; achievement defined as score of 4 or 5."}
  • {"endpoint_text":"- Achievement of PaGIC-V of \"Much better (1)\" at Week 48.","definition_or_measurement_approach":"Patient Global Impression of Change for vitiligo (PaGIC-V) measured at Week 48; achievement defined as 'Much better (1)'."}
  • {"endpoint_text":"- Achievement of PhGIC-V of \"Much better (1)\" at Week 48;","definition_or_measurement_approach":"Physician Global Impression of Change for vitiligo (PhGIC-V) measured at Week 48; achievement defined as 'Much better (1)'."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
381
Recruitment Window Months
46
Consent Approach
Informed consent is required prior to any screening or study procedures; adults provide written informed consent. Adolescents (≥12 to <18 years) provide assent and parent/guardian (or legally authorized representative where required) must provide consent; provision for legally authorized representative consent per local regulations. ICFs, assent forms, and parent/guardian ICFs are prepared and available in multiple languages per country (English, Dutch, French, German, Bulgarian, Polish, Portuguese, Slovak, Hungarian and others as per country-specific documents). All consent/assent documents are IEC/IRB approved.

Methods

  • Search Ads — online search advertising (documents titled 'Search Ads') targeting potential participants via internet search channels (country-specific materials available, e.g., DE, BG).
  • Digital Ads — online display/digital advertising (documents titled 'Digital Ads' / 'Social Media Script') targeting patients via social media and digital channels (country-specific scripts present).
  • Social Media Scripts — social media channel messaging/content for patient recruitment (country-specific social media script documents).
  • Doctor to Patient Email — emails from physicians to patients to inform about the study (documents titled 'Doctor to Patient Email' per country).
  • Recruitment Brochure / Flyer — printable brochures and flyers for distribution at clinics/sites (country-specific brochures/flyers available).
  • Landing Page Copy — dedicated study landing page content to capture interested patients (documents titled 'Landing Page Copy').
  • Database and Patient Messaging — messaging to patient databases or registries via sites (documents titled 'Database and Patient Messaging').
  • Master Screener / Master CC and WS Script — site-level screening scripts and call-center scripts for screening potential participants.

Geography

Total Number Of Sites
60
Total Number Of Participants
381

Hungary

Earliest CTIS Part Ii Submission Date
11-04-2024
Latest Decision Or Authorization Date
06-06-2024
Processing Time Days
56
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Derma-B Kft.
Contact Person Name
Emese Heredi
Contact Person Email
emeseheredi@gmail.com
Site Name
Semmelweis University
Department Name
Bor-, Nemikortani es Boronkologiai Klinika
Contact Person Name
Peter Hollo

Bulgaria

Earliest CTIS Part Ii Submission Date
04-12-2023
Latest Decision Or Authorization Date
21-11-2025
Processing Time Days
718
Number Of Sites
5
Number Of Participants
16

Sites

Site Name
Medical Center Kordis OOD
Contact Person Name
Dimitar Gospodinov
Contact Person Email
dkg@abv.bg
Site Name
Military Medical Academy
Department Name
Department of Dermatology
Contact Person Name
Vessel Kantardjiev
Contact Person Email
v.kantarjiev@vma.bg
Site Name
ASMC IPSMC Skin And Venereal Diseases
Contact Person Name
Ivan Botev
Contact Person Email
botev2@yahoo.com
Site Name
Diagnostic Consultation Center XX-Sofia EOOD
Contact Person Name
Toma Tomov
Contact Person Email
toma_tomov2015@abv.bg
Site Name
Dkc Fokus-5 Lzip OOD
Contact Person Name
Grisha Mateev
Contact Person Email
grisha_mateev@yahoo.com

Belgium

Earliest CTIS Part Ii Submission Date
28-02-2024
Latest Decision Or Authorization Date
24-11-2025
Processing Time Days
635
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Grand Hopital De Charleroi
Department Name
Dermatology
Contact Person Name
Pierre Paul Roquet-Gravy
Site Name
CHU De Liege
Department Name
Dermatology
Contact Person Name
Arjen Nikkels
Contact Person Email
af.nikkels@chuliege.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Dermatology
Contact Person Name
Pierre Dominique Ghislain
Site Name
Universitair Ziekenhuis Gent
Department Name
Dermatology
Contact Person Name
Reinhart Speeckaert
Contact Person Email
reinhart.speeckaert@uzgent.be

Portugal

Earliest CTIS Part Ii Submission Date
05-02-2024
Latest Decision Or Authorization Date
18-11-2025
Processing Time Days
592
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Centro Hospitalar E Universitario De Coimbra E.P.E.
Department Name
Dermatology
Contact Person Name
Leonor Ramos
Contact Person Email
leonoricr@gmail.com
Site Name
Centro Hospitalar Universitario De Santo Antonio E.P.E.
Department Name
Dermatology
Contact Person Name
Tiago Torres
Contact Person Email
torres.tiago@outlook.com
Site Name
Centro Hospitalar De Leiria E.P.E.
Department Name
Dermatology
Contact Person Name
Tiago Gomes
Site Name
Hospital Cuf Descobertas S.A.
Department Name
Dermatology
Contact Person Name
Pedro Mendes-Bastos
Contact Person Email
pmendesbastos@gmail.com

Netherlands

Earliest CTIS Part Ii Submission Date
28-02-2024
Latest Decision Or Authorization Date
20-11-2025
Processing Time Days
631
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Amsterdam UMC
Department Name
Dermatology
Contact Person Name
Albert Wolkerstorfer
Site Name
Bravis Ziekenhuis
Department Name
Dermatology
Contact Person Name
Milan Tjioe
Contact Person Email
m.tjioe@bravis.nl
Site Name
Amphia Hospital
Department Name
Dermatology
Contact Person Name
Bas Prens
Contact Person Email
BPrens@amphia.nl

Slovakia

Earliest CTIS Part Ii Submission Date
16-02-2024
Latest Decision Or Authorization Date
18-11-2025
Processing Time Days
641
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
Fakultna Nemocnica Trnava
Department Name
dermatologia
Contact Person Name
Peter Kozub
Contact Person Email
peter.kozub.derm@gmail.com
Site Name
Fakultna Nemocnica S Poliklinikou J. A. Reimana Presov
Department Name
dermatologia
Contact Person Name
Silvia Petrova
Contact Person Email
petrovasilvia11@gmail.com
Site Name
Derma therapy spol. s r.o.
Department Name
Derma therapy, spol. s r.o.
Contact Person Name
Michaela Dubcekova
Contact Person Email
mdubcekova@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
16-02-2024
Latest Decision Or Authorization Date
18-11-2025
Processing Time Days
641
Number Of Sites
11
Number Of Participants
53

Sites

Site Name
Technische Universitat Dresden
Department Name
Klinik und Poliklinik für Dermatologie
Principal Investigator Name
Roland Aschoff
Principal Investigator Email
dermastudien@ukdd.de
Contact Person Name
Roland Aschoff
Contact Person Email
dermastudien@ukdd.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Principal Investigator Name
Kamran Ghoreschi
Principal Investigator Email
kamran.ghoreschi@charite.de
Contact Person Name
Kamran Ghoreschi
Contact Person Email
kamran.ghoreschi@charite.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Hautklinik
Principal Investigator Name
Michael Sticherling
Principal Investigator Email
studien.de@uk-erlangen.de
Contact Person Name
Michael Sticherling
Contact Person Email
studien.de@uk-erlangen.de
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein
Principal Investigator Name
Bernadette Eberlein
Principal Investigator Email
studienambulanz.de@mri.tum.de
Contact Person Name
Bernadette Eberlein
Contact Person Email
studienambulanz.de@mri.tum.de
Site Name
Universitaet Muenster
Department Name
Klinik für Hautkrankheiten, Zentrale Studienkoordination für innovative Dermatologie (ZID)
Principal Investigator Name
Nina Magnolo
Principal Investigator Email
Nina.Magnolo@ukmuenster.der
Contact Person Name
Nina Magnolo
Contact Person Email
Nina.Magnolo@ukmuenster.der
Site Name
Praxis Dr. med. Abdou Zarzour
Principal Investigator Name
Abdou Zarzour
Principal Investigator Email
Zarzour@gmx.de
Contact Person Name
Abdou Zarzour
Contact Person Email
Zarzour@gmx.de
Site Name
MVZ Dermatologisches Zentrum Bonn GmbH
Principal Investigator Name
Uwe Reinhold
Principal Investigator Email
info@derma-bonn.de
Contact Person Name
Uwe Reinhold
Contact Person Email
info@derma-bonn.de
Site Name
Goethe University Frankfurt
Department Name
Klinik für Dermatologie, Venerologie und Allergologie, Klinische Forschung
Principal Investigator Name
Andreas Pinter
Principal Investigator Email
decker-klifo-ffm@gmx.de
Contact Person Name
Andreas Pinter
Contact Person Email
decker-klifo-ffm@gmx.de
Site Name
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR
Principal Investigator Name
Michael Sebastian
Principal Investigator Email
kontakt@derma-mahlow.de
Contact Person Name
Michael Sebastian
Contact Person Email
kontakt@derma-mahlow.de
Site Name
Thermalsole und Schwefelbad Bentheim GmbH
Department Name
Klinisches Studienzentrum
Principal Investigator Name
Athanasios Tsianakas
Principal Investigator Email
studien-dermatologie@fk-bentheim.de
Contact Person Name
Athanasios Tsianakas
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Dermatologie / Clinical Research Center
Principal Investigator Name
Petra Staubach-Renz
Principal Investigator Email
crc-hautklinik@unimedizin-mainz.de
Contact Person Name
Petra Staubach-Renz

Poland

Earliest CTIS Part Ii Submission Date
04-12-2023
Latest Decision Or Authorization Date
21-11-2025
Processing Time Days
718
Number Of Sites
11
Number Of Participants
56

Sites

Site Name
Futuremeds Sp. z o.o.
Contact Person Name
Agnieszka Synarska-Drygalska
Site Name
Osteo Medic s.c. Artur Racewicz Jerzy Supronik
Contact Person Name
Małgorzata Janczyło-Jankowska
Contact Person Email
jjgosia@gmail.com
Site Name
Klinika Osipowicz & Turkowski Sp. z o.o.
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.
Contact Person Name
Paweł Brzewski
Contact Person Email
brzewski@sgd-polska.com
Site Name
DermoDent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski s.c
Contact Person Name
Rafał Czajkowski
Contact Person Email
r.czajkowski@dermodent.pl
Site Name
ROYALDERM AGNIESZKA NAWROCKA
Contact Person Name
Witold Owczarek
Contact Person Email
kontakt@royalderm.pl
Site Name
Klinika Ambroziak Sp. z o.o.
Contact Person Name
Monika Kałowska
Site Name
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Contact Person Name
Tadeusz Dębniak
Contact Person Email
debniak@twojaprzychodnia.com
Site Name
Malopolskie Centrum Kliniczne
Contact Person Name
Teresa Kusiba-Wodniak
Contact Person Email
tkwodniak@mck-krakow.pl
Site Name
Provita Sp. z o.o.
Contact Person Name
Anita Lewartowska-Białek
Contact Person Email
a.bialek@angelius.org
Site Name
additional listed Polish site(s)

Italy

Earliest CTIS Part Ii Submission Date
01-03-2024
Latest Decision Or Authorization Date
19-11-2025
Processing Time Days
628
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Ospedale San Raffaele S.r.l.
Department Name
Unit of Dermatology and Cosmetology
Principal Investigator Name
Santo Raffaele Mercuri
Principal Investigator Email
mercuri.santoraffaele@hsr.it
Contact Person Name
Santo Raffaele Mercuri
Contact Person Email
mercuri.santoraffaele@hsr.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Complex structure of Dermatology
Principal Investigator Name
Cristina Magnoni
Principal Investigator Email
cristina.magnoni@unimore.it
Contact Person Name
Cristina Magnoni
Contact Person Email
cristina.magnoni@unimore.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
U.O. Dermatology
Principal Investigator Name
Mariachiara Arisi
Principal Investigator Email
mariachiara.arisi@gmail.com
Contact Person Name
Mariachiara Arisi
Contact Person Email
mariachiara.arisi@gmail.com
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Complex Operative Unit of Clinic dermatology
Principal Investigator Name
Paolo Iacovelli
Principal Investigator Email
paolo.iacovelli@ifo.it
Contact Person Name
Paolo Iacovelli
Contact Person Email
paolo.iacovelli@ifo.it

France

Earliest CTIS Part Ii Submission Date
06-03-2024
Latest Decision Or Authorization Date
01-12-2025
Processing Time Days
635
Number Of Sites
5
Number Of Participants
27

Sites

Site Name
Hospital Edouard Herriot
Department Name
SERVICE DE DERMATOLOGIE
Principal Investigator Name
Cécile LESORT
Principal Investigator Email
Cecile.lesort@chu-lyon.fr
Contact Person Name
Cécile LESORT
Contact Person Email
Cecile.lesort@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
Centre Hospitalier Universitaire De Bordeaux
Department Name
SERVICE DE DERMATOLOGIE ADULTE ET PEDIATRIQUE
Principal Investigator Name
Julien SENESCHAL
Principal Investigator Email
julien.seneschal@chu-bordeaux.fr
Contact Person Name
Julien SENESCHAL
Site Name
Assistance Publique Hopitaux De Paris
Department Name
SERVICE DE DERMATOLOGIE
Principal Investigator Name
Khaled EZZEDINE
Principal Investigator Email
khaled.ezzedine@aphp.fr
Contact Person Name
Khaled EZZEDINE
Contact Person Email
khaled.ezzedine@aphp.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
CENTRE DES MALADIE RARES DE LA PEAU - SERVICE DE DERMATOLOGIE
Principal Investigator Name
Juliette MAZEREEUW-HAUTIER
Principal Investigator Email
mazereeuw-hautier.j@chu-toulouse.fr
Contact Person Name
Juliette MAZEREEUW-HAUTIER

Spain

Earliest CTIS Part Ii Submission Date
27-02-2024
Latest Decision Or Authorization Date
11-02-2026
Processing Time Days
715
Number Of Sites
8
Number Of Participants
26

Sites

Site Name
Hospital General Universitario De Valencia
Department Name
Servicio de Dermatología
Principal Investigator Name
Jorge Magdaleno Tapial
Principal Investigator Email
jormagta@gmail.com
Contact Person Name
Jorge Magdaleno Tapial
Contact Person Email
jormagta@gmail.com
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Servicio de Dermatología
Principal Investigator Name
Javier Pedraz Muñoz
Principal Investigator Email
javierpedraz78@gmail.com
Contact Person Name
Javier Pedraz Muñoz
Contact Person Email
javierpedraz78@gmail.com
Site Name
Hospital Universitario Clinico San Cecilio
Department Name
Servicio de Dermatología
Principal Investigator Name
Jose Carlos Ruiz Carrascosa
Principal Investigator Email
ruizcarrascosa@movistar.es
Contact Person Name
Jose Carlos Ruiz Carrascosa
Contact Person Email
ruizcarrascosa@movistar.es
Site Name
Hospital Universitario De Getafe
Department Name
Servicio de Dermatología
Principal Investigator Name
Héctor Muñoz González
Principal Investigator Email
hector.munoz@salud.madrid.org
Contact Person Name
Héctor Muñoz González
Contact Person Email
hector.munoz@salud.madrid.org
Site Name
Hospital Germans Trias I Pujol
Department Name
Servicio de Dermatología
Principal Investigator Name
Ane jaka Moreno
Principal Investigator Email
ajaka.germanstrias@gencat.cat
Contact Person Name
Ane jaka Moreno
Contact Person Email
ajaka.germanstrias@gencat.cat
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Servicio de Dermatología
Principal Investigator Name
Mariano Ara Martin
Principal Investigator Email
mariano_ara@yahoo.es
Contact Person Name
Mariano Ara Martin
Contact Person Email
mariano_ara@yahoo.es
Site Name
Icr Medical S.L.
Department Name
Servicio de Dermatología (Grupo Pedro Jaen)
Principal Investigator Name
Gonzalo Segurado Miravalles
Principal Investigator Email
j.villanueva@pjaen.com
Contact Person Name
Gonzalo Segurado Miravalles
Contact Person Email
j.villanueva@pjaen.com
Site Name
additional listed Spanish site(s)

Sponsor

Primary sponsor

Full Name
AbbVie Deutschland GmbH & Co. KG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
Advarra Inc.
Responsibilities
code: 3
Name
WCG Clinical Inc.
Responsibilities
Training, Cardiac and GI Adjudication

Third parties

  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Imaging","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Cherry Pharma Limited","duties_or_roles":"Imaging","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Advarra Inc.","duties_or_roles":"code: 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Training, Cardiac and GI Adjudication","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Upadacitinib
Active Substance
UPADACITINIB
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised
Starting Dose
15 mg
Dose Levels
15 mg
Frequency
Once daily
Maximum Dose
15 mg (max daily dose amount listed as 15 mg)
Investigational Product Name
Upadacitinib Placebo
Modality
Other

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