Clinical trial • Phase III • Immunology|Dermatology

UPADACITINIB for Alopecia areata | Severe alopecia areata

Phase III trial of UPADACITINIB for Alopecia areata | Severe alopecia areata.

Overview

Trial Therapeutic Area
Immunology|Dermatology
Trial Disease
Alopecia areata | Severe alopecia areata
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
10-11-2023
First CTIS Authorization Date
18-03-2024

Trial design

Randomised, upadacitinib 15 mg qd and upadacitinib 30 mg qd compared with placebo-controlled, adaptive Phase III trial in Slovakia, Belgium, Croatia and others.

Randomised
Yes
Comparator
Upadacitinib 15 mg QD and Upadacitinib 30 mg QD compared with placebo
Adaptive
True (includes dose reduction to 15 mg QD for subjects achieving sustained response and dose escalation to 30 mg QD for subjects who have not achieved response; re-randomization in extension periods and dose-adjustment rules specified)
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
990
Trial Duration For Participant
1120

Eligibility

Recruits 990 paediatric patients.

Vulnerable Population
Adolescents are included where permitted (adolescents at least 12 years old at Screening outside US/EU where allowed). The submission includes adolescent assent and parental/guardian consent documents (assent forms for ages 12-14 and 15-17, parental/guardian ICFs) and country-specific ICF/assent documents to manage consent.

Inclusion criteria

  • {"criterion_text":"- Eligible subjects will be adults < 64 years old at Baseline and, where permitted outside US/EU adolescents at least 12 years old at Screening with a diagnosis of severe AA with SALT score ≥ 50 scalp hair loss at Screening and Baseline and no spontaneous scalp hair regrowth over the past 6 months AND no significant scalp hair loss over the past 3 months\n- Must have current episode of AA of less than 8 years."}

Exclusion criteria

  • {"criterion_text":"- Subject has a diagnosis of primarily diffuse type of AA\n- Subject has a diagnosis of other types of alopecia that would interfere with evaluation of AA, including but not limited to female pattern hair loss, male pattern hair loss (androgenetic alopecia) Stage III or greater based on Hamilton-Norwood classification, traction alopecia, lichen planopilaris, discoid lupus, frontal fibrosing alopecia, central centrifugal cicatricial alopecia, folliculitis decalvans, trichotillomania, and telogen effluvium.\n- Subject has a diagnosis of other types of inflammatory scalp, eyebrow, or eyelash disorders that would interfere with evaluation of AA, including but not limited to seborrheic dermatitis, scalp psoriasis, AD, and tinea capitis."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Study 1 and Study 2 The primary endpoint is the achievement of SALT score ≤ 20 at Week 24, defined as less than or equal to 20% scalp hair loss.","definition_or_measurement_approach":"Achievement of SALT score ≤ 20 at Week 24 (SALT = Severity of Alopecia Tool; defined here as ≤ 20% scalp hair loss)"}

Secondary endpoints

  • {"endpoint_text":"- Achievement of SALT score <= 10 at Week 24","definition_or_measurement_approach":"SALT score measured at Week 24 (<=10)"}
  • {"endpoint_text":"- Achievement of SALT score <= 20 at Week 12","definition_or_measurement_approach":"SALT score measured at Week 12 (<=20)"}
  • {"endpoint_text":"- Achievement of ClinRO measure for Eyebrow Hair Loss of 0 or 1 at Week 24 with a ≥ 2-point improvement (reduction) from Baseline among subjects with Baseline score ≥ 2","definition_or_measurement_approach":"ClinRO assessment for eyebrow hair loss at Week 24 with ≥2-point improvement from Baseline in subjects with Baseline ≥2"}
  • {"endpoint_text":"- Achievement of ClinRO measure for Eyelash Hair Loss of 0 or 1 at Week 24 with a ≥ 2-point improvement (reduction) from Baseline among subjects with Baseline score ≥ 2","definition_or_measurement_approach":"ClinRO assessment for eyelash hair loss at Week 24 with ≥2-point improvement from Baseline in subjects with Baseline ≥2"}
  • {"endpoint_text":"- Achievement of SALT 75 at Week 24","definition_or_measurement_approach":"Achievement of SALT 75 (≥75% improvement in SALT from Baseline) at Week 24"}
  • {"endpoint_text":"- Achievement of SALT 90 (at least a 90% improvement [decrease] from Baseline in SALT score) at Week 24","definition_or_measurement_approach":"Achievement of SALT 90 (≥90% improvement from Baseline) at Week 24"}
  • {"endpoint_text":"- Percent change from Baseline in SALT score at Week 24","definition_or_measurement_approach":"Percent change in SALT score from Baseline to Week 24"}
  • {"endpoint_text":"- Achievement of PaGIC-AA score of 1 \"much better\" or 2 \"moderately better\" at Week 24","definition_or_measurement_approach":"Patient Global Impression of Change in AA (PaGIC-AA) at Week 24"}
  • {"endpoint_text":"- Achievement of PRO for Scalp Hair Assessment 0/1 with ≥ 2-point improvement (reduction) from Baseline at Week 24 among subjects with Baseline score ≥ 3","definition_or_measurement_approach":"Patient-reported outcome for scalp hair assessment at Week 24 with ≥2-point improvement from Baseline in subjects with Baseline ≥3"}
  • {"endpoint_text":"- Change from Baseline in Skindex-16 AA Emotions Domain scores at Week 24","definition_or_measurement_approach":"Change from Baseline in Skindex-16 AA Emotions Domain at Week 24"}
  • {"endpoint_text":"- Change from Baseline in Skindex-16 AA Functioning Domain scores at Week 24","definition_or_measurement_approach":"Change from Baseline in Skindex-16 AA Functioning Domain at Week 24"}
  • {"endpoint_text":"- Change from Baseline in AASIS Interference Subscale score at Week 24","definition_or_measurement_approach":"Change from Baseline in AASIS Interference Subscale at Week 24"}
  • {"endpoint_text":"- Change from Baseline in AASIS Symptoms Subscale score at Week 24","definition_or_measurement_approach":"Change from Baseline in AASIS Symptoms Subscale at Week 24"}
  • {"endpoint_text":"- ·Achievement of HADS-A < 8 and HADS-D < 8 at Week 24 among subjects with HADS-A ≥ 8 or HADS-D ≥ 8 at Baseline","definition_or_measurement_approach":"Achievement of HADS-Anxiety <8 and HADS-Depression <8 at Week 24 among subjects with baseline scores ≥8"}
  • {"endpoint_text":"- Achievement of SALT score 0 at Week 24","definition_or_measurement_approach":"SALT score of 0 (complete scalp hair regrowth) at Week 24"}
  • {"endpoint_text":"- Achievement of SALT score ≤ 20 at Week 8","definition_or_measurement_approach":"SALT score measured at Week 8 (≤20)"}
  • {"endpoint_text":"- Achievement of PaGIC-AA score of 1 \"much better\" or 2 \"moderately better\" at Week 4","definition_or_measurement_approach":"PaGIC-AA at Week 4"}
  • {"endpoint_text":"- Achievement of SALT score ≤ 20 at Week 4","definition_or_measurement_approach":"SALT score measured at Week 4 (≤20)"}
  • {"endpoint_text":"- Achievement of SALT score <= 20 at Week 24, for the comparison of upadacitinb 15 mg QD versus placebo","definition_or_measurement_approach":"Comparison between upadacitinib 15 mg QD and placebo: proportion achieving SALT ≤20 at Week 24"}

Recruitment

Digital Remote Recruitment
True (uses social media videos, digital/search ads, landing pages, database & patient messaging, online master screener/webscreener and digital recruitment materials as described in country recruitment documents)
Planned Sample Size
990
Recruitment Window Months
46
Consent Approach
Adults provide written informed consent. Adolescents (where permitted; at least 12 years old outside US/EU where allowed) provide assent and require parental/guardian consent; country-specific adolescent assent forms and parent/guardian ICFs are provided. Multiple language versions and country-specific ICFs/assent documents are included (examples in English, French, German, Dutch, Spanish, Italian, Portuguese, Swedish, Hungarian, Croatian, Polish, Greek, Bulgarian, etc., as per documents list).

Methods

  • Digital and social media advertising (social media videos, digital ads, search ads) — country-specific digital campaigns described in recruitment documents (examples: ES, IT, SE, PL).
  • Landing pages and online patient messaging / database outreach (landing pages, database & patient messaging documents present for multiple countries).
  • Doctor-to-patient email communications and site-based outreach (doctor to patient email templates available in several countries).
  • Printed recruitment materials and brochures (recruitment brochures, caregiver brochures, recruitment flyers) distributed via sites and caregivers.
  • Web/phone pre-screening using Master Screener / Webscreener scripts (master screener and master web-screener scripts provided).
  • Site-specific advertisements and retention messaging (site ads and retention messaging materials listed).

Geography

Slovakia

Earliest CTIS Part Ii Submission Date
01-03-2024
Latest Decision Or Authorization Date
24-10-2025
Number Of Sites
4
Number Of Participants
30

Sites

Site Name
University Hospital Bratislava
Department Name
Dermatology Department
Principal Investigator Name
Maria Simaljakova
Principal Investigator Email
maria.simaljakova@sm.unb.sk
Contact Person Name
Maria Simaljakova
Contact Person Email
maria.simaljakova@sm.unb.sk
Site Name
Fakultna Nemocnica S Poliklinikou J. A. Reimana Presov
Department Name
Dermatology Department
Principal Investigator Name
Petra Imlejova
Principal Investigator Email
petra.imlejova@gmail.com
Contact Person Name
Petra Imlejova
Contact Person Email
petra.imlejova@gmail.com
Site Name
Kaderma Majtan s.r.o.
Department Name
Dermatology Department
Principal Investigator Name
Eva Majtanova
Principal Investigator Email
info@majtanestetics.sk
Contact Person Name
Eva Majtanova
Contact Person Email
info@majtanestetics.sk
Site Name
Derma therapy spol. s r.o.
Department Name
Dermatology Department
Principal Investigator Name
Michaela Dubcekova
Principal Investigator Email
mdubcekova.vyskum@gmail.com
Contact Person Name
Michaela Dubcekova
Contact Person Email
mdubcekova.vyskum@gmail.com

Belgium

Earliest CTIS Part Ii Submission Date
26-02-2024
Latest Decision Or Authorization Date
27-10-2025
Number Of Sites
6
Number Of Participants
36

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Dermatology Department
Principal Investigator Name
Reinhart Speeckaert
Principal Investigator Email
reinhart.speeckaert@ugent.be
Contact Person Name
Reinhart Speeckaert
Contact Person Email
reinhart.speeckaert@ugent.be
Site Name
UZ Brussel
Department Name
Dermatology Department
Principal Investigator Name
Martine Grosber
Principal Investigator Email
martine.grosber@uzbrussel.be
Contact Person Name
Martine Grosber
Contact Person Email
martine.grosber@uzbrussel.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Dermatology Department
Principal Investigator Name
Pierre-Dominique Ghislain
Principal Investigator Email
pierre-dominique.ghislain@uclouvain.be
Contact Person Name
Pierre-Dominique Ghislain
Site Name
Hopital Erasme
Department Name
Dermatology Department
Principal Investigator Name
Farida Benhadou
Principal Investigator Email
farida.benhadou@hubruxelles.be
Contact Person Name
Farida Benhadou
Contact Person Email
farida.benhadou@hubruxelles.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Dermatology
Principal Investigator Name
Annelies Stockman
Principal Investigator Email
annelies.stockman@azdelta.com
Contact Person Name
Annelies Stockman
Contact Person Email
annelies.stockman@azdelta.com
Site Name
CHU De Liege
Department Name
Dermatology Department
Principal Investigator Name
Arjen Nikkels
Principal Investigator Email
af.nikkels@chuliege.be
Contact Person Name
Arjen Nikkels
Contact Person Email
af.nikkels@chuliege.be

Croatia

Earliest CTIS Part Ii Submission Date
13-03-2024
Latest Decision Or Authorization Date
04-05-2026
Number Of Sites
5
Number Of Participants
25

Sites

Site Name
Poliklinika Solmed d.o.o.
Department Name
Dermatology Department
Principal Investigator Name
Iva Blajic
Principal Investigator Email
info@solmed-clinic.com
Contact Person Name
Iva Blajic
Contact Person Email
info@solmed-clinic.com
Site Name
KBC Split
Department Name
Dermatology Department
Principal Investigator Name
Ana Sanader Vucemilovic
Principal Investigator Email
der.poliklinika@kbsplit.hr
Contact Person Name
Ana Sanader Vucemilovic
Contact Person Email
der.poliklinika@kbsplit.hr
Site Name
KBC Zagreb
Department Name
Dermatology Department
Principal Investigator Name
Davorin Loncaric
Principal Investigator Email
kbc-zagreb@kbc-zagreb.hr
Contact Person Name
Davorin Loncaric
Contact Person Email
kbc-zagreb@kbc-zagreb.hr
Site Name
Poliklinika Dermaplus
Department Name
Dermatology Department
Principal Investigator Name
Lena Kotrulja
Principal Investigator Email
info@dermaplus.hr
Contact Person Name
Lena Kotrulja
Contact Person Email
info@dermaplus.hr
Site Name
Specijalna Bolnica Medico
Department Name
Dermatology Department
Principal Investigator Name
Sandra Peternel
Principal Investigator Email
medico@medico.hr
Contact Person Name
Sandra Peternel
Contact Person Email
medico@medico.hr

Hungary

Earliest CTIS Part Ii Submission Date
29-02-2024
Latest Decision Or Authorization Date
30-04-2026
Number Of Sites
8
Number Of Participants
42

Sites

Site Name
University Of Szeged
Department Name
Borgyogyaszati es Allergologiai Klinika
Principal Investigator Name
Rolland Gyulai
Principal Investigator Email
gyulai.rolland@med.u-szeged.hu
Contact Person Name
Rolland Gyulai
Contact Person Email
gyulai.rolland@med.u-szeged.hu
Site Name
University Of Pecs
Department Name
Bor-, Nemikortani es Onkodermatologiai Klinika
Principal Investigator Name
Adriána Evelin Csernus
Principal Investigator Email
csernus.adriana@pte.hu
Contact Person Name
Adriána Evelin Csernus
Contact Person Email
csernus.adriana@pte.hu
Site Name
Meditres Ltd.
Department Name
-
Principal Investigator Name
Julia Komlodi
Principal Investigator Email
komlodi.julia@bagolyegeszseghaz.hu
Contact Person Name
Julia Komlodi
Site Name
Derma-B Kft.
Department Name
-
Principal Investigator Name
Emese Heredi
Principal Investigator Email
info@dririnyi.hu
Contact Person Name
Emese Heredi
Contact Person Email
info@dririnyi.hu
Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
Borgyogyaszati Szakrendeles
Principal Investigator Name
Ivan Orojan
Principal Investigator Email
orojani@kmk.hu
Contact Person Name
Ivan Orojan
Contact Person Email
orojani@kmk.hu
Site Name
W-N Med Kft.
Department Name
-
Principal Investigator Name
Norbert Wikonkal
Principal Investigator Email
wikonkal.norbert@gmail.com
Contact Person Name
Norbert Wikonkal
Contact Person Email
wikonkal.norbert@gmail.com
Site Name
University Of Debrecen
Department Name
Borgyogyaszati Klinika
Principal Investigator Name
Andrea Szegedi
Principal Investigator Email
aszegedi@med.unideb.hu
Contact Person Name
Andrea Szegedi
Contact Person Email
aszegedi@med.unideb.hu
Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz (additional site entry)
Department Name
-
Principal Investigator Name
Norbert Wikonkal
Principal Investigator Email
wikonkal.norbert@gmail.com
Contact Person Name
Norbert Wikonkal
Contact Person Email
wikonkal.norbert@gmail.com

Greece

Earliest CTIS Part Ii Submission Date
01-03-2024
Latest Decision Or Authorization Date
29-04-2026
Number Of Sites
4
Number Of Participants
24

Sites

Site Name
General Hospital Of Thessaloniki Papageorgiou
Department Name
2nd Department of Dermatology-Venereology
Principal Investigator Name
Elisavet Lazaridou
Principal Investigator Email
bdermaclinic@gmail.com
Contact Person Name
Elisavet Lazaridou
Contact Person Email
bdermaclinic@gmail.com
Site Name
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
Department Name
A' University Dermatology Clinic
Principal Investigator Name
Alexandros Stratigos
Principal Investigator Email
derm1@med.uoa.gr
Contact Person Name
Alexandros Stratigos
Contact Person Email
derm1@med.uoa.gr
Site Name
Andreas Syngros Hospital Of Venereal And Dermatological Diseases (second site record)
Department Name
Dermatology-Venereology Department of NHS
Principal Investigator Name
Vasiliki Chasapi
Principal Investigator Email
dermnhs@syggros.gr
Contact Person Name
Vasiliki Chasapi
Contact Person Email
dermnhs@syggros.gr
Site Name
Ippokratio General Hospital Of Thessaloniki
Department Name
A' Dermatology Clinic AUTh
Principal Investigator Name
Eleni Sotiriou
Principal Investigator Email
aderma.studies@gmail.com
Contact Person Name
Eleni Sotiriou
Contact Person Email
aderma.studies@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
08-03-2024
Latest Decision Or Authorization Date
04-05-2026
Number Of Sites
7
Number Of Participants
42

Sites

Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Dermatology Department
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 La Paz
Department Name
Dermatology Department
Principal Investigator Name
Pedro Francisco Herranz Pinto
Principal Investigator Email
pedro.herranz@salud.madrid.org
Contact Person Name
Pedro Francisco Herranz Pinto
Contact Person Email
pedro.herranz@salud.madrid.org
Site Name
Bellvitge University Hospital
Department Name
Dermatology Department
Principal Investigator Name
Ignacio Figueras Nart
Principal Investigator Email
ignasifiguerasnart@gmail.com
Contact Person Name
Ignacio Figueras Nart
Contact Person Email
ignasifiguerasnart@gmail.com
Site Name
Hospital Universitario Dr Peset Aleixandre
Department Name
Dermatology Department
Principal Investigator Name
Almudena Mateu Puchades
Principal Investigator Email
amateupuchades@gmail.com
Contact Person Name
Almudena Mateu Puchades
Contact Person Email
amateupuchades@gmail.com
Site Name
Hospital Universitario De Fuenlabrada
Department Name
Dermatology Department
Principal Investigator Name
Alberto Romero Mate
Principal Investigator Email
aromerom@salud.madrid.org
Contact Person Name
Alberto Romero Mate
Contact Person Email
aromerom@salud.madrid.org
Site Name
Hospital Universitario Reina Sofia
Department Name
Dermatology Department
Principal Investigator Name
Manuel Galan Gutierrez
Principal Investigator Email
minos72@hotmail.com
Contact Person Name
Manuel Galan Gutierrez
Contact Person Email
minos72@hotmail.com
Site Name
Hospital Universitario De Fuenlabrada (additional or alternate record)
Department Name
Dermatology Department
Principal Investigator Name
Alberto Romero Mate
Principal Investigator Email
aromerom@salud.madrid.org
Contact Person Name
Alberto Romero Mate
Contact Person Email
aromerom@salud.madrid.org

Poland

Earliest CTIS Part Ii Submission Date
07-03-2024
Latest Decision Or Authorization Date
30-04-2026
Number Of Sites
11
Number Of Participants
100

Sites

Site Name
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno Badawczy Marek Brzewski Paweł Brzewski s.c.
Department Name
Dermatology Department
Principal Investigator Name
Paweł Brzewski
Principal Investigator Email
brzewski@sgd-polska.com
Contact Person Name
Paweł Brzewski
Contact Person Email
brzewski@sgd-polska.com
Site Name
Royalderm Agnieszka Nawrocka
Department Name
Dermatology Department
Principal Investigator Name
Witold Owczarek
Principal Investigator Email
kontakt@royalderm.pl
Contact Person Name
Witold Owczarek
Contact Person Email
kontakt@royalderm.pl
Site Name
Centrum Medyczne All-Med Badania Kliniczne
Department Name
Dermatology Department
Principal Investigator Name
Karolina Pelka
Principal Investigator Email
pelkakarola@gmail.com
Contact Person Name
Karolina Pelka
Contact Person Email
pelkakarola@gmail.com
Site Name
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Department Name
Dermatology Department
Principal Investigator Name
Aleksandra Okuniewska
Principal Investigator Email
a.okuniewska@pihouse.pl
Contact Person Name
Aleksandra Okuniewska
Contact Person Email
a.okuniewska@pihouse.pl
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
Dermatology Department
Principal Investigator Name
Aleksandra Badzian
Principal Investigator Email
a.badzian@naszlekarz.pl
Contact Person Name
Aleksandra Badzian
Contact Person Email
a.badzian@naszlekarz.pl
Site Name
Klinika Osipowicz & Turkowski Sp. z o.o.
Department Name
Dermatology Department
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
Provita Sp. z o.o.
Department Name
Dermatology Department
Principal Investigator Name
Anita Lewartowska-Bialek
Principal Investigator Email
a.lewartowska-bialek@angelius.org
Contact Person Name
Anita Lewartowska-Bialek
Site Name
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
Department Name
Dermatology Department
Principal Investigator Name
Danuta Dabrowska
Principal Investigator Email
danuta.dabrowska@ckb.elblag.pl
Contact Person Name
Danuta Dabrowska
Contact Person Email
danuta.dabrowska@ckb.elblag.pl
Site Name
Osteo Medic s.c. Artur Racewicz Jerzy Supronik
Department Name
Dermatology Department
Principal Investigator Name
Małgorzata Janczylo-Jankowska
Principal Investigator Email
jjgosia@gmail.com
Contact Person Name
Małgorzata Janczylo-Jankowska
Contact Person Email
jjgosia@gmail.com
Site Name
Centrum Badan Klinicznych Pi-House Sp. z o.o. (additional record)
Department Name
Dermatology
Principal Investigator Name
Aleksandra Okuniewska
Principal Investigator Email
a.okuniewska@pihouse.pl
Contact Person Name
Aleksandra Okuniewska
Contact Person Email
a.okuniewska@pihouse.pl
Site Name
Specjalistyczny Gabinet Dermatologiczny (additional record)
Department Name
Dermatology Department
Principal Investigator Name
Paweł Brzewski
Principal Investigator Email
brzewski@sgd-polska.com
Contact Person Name
Paweł Brzewski
Contact Person Email
brzewski@sgd-polska.com

Sweden

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
29-04-2026
Number Of Sites
3
Number Of Participants
18

Sites

Site Name
Diagnostiskt Centrum Hud i Sickla AB
Department Name
Dermatology Department
Principal Investigator Name
Petra Kjellman
Principal Investigator Email
petra.kjellman@dchud.se
Contact Person Name
Petra Kjellman
Contact Person Email
petra.kjellman@dchud.se
Site Name
CTC Clinical Trial Consultants AB
Department Name
Dermatology Department
Principal Investigator Name
Ulrika Risedal
Principal Investigator Email
ulrika.risedal@ctc-ab.se
Contact Person Name
Ulrika Risedal
Contact Person Email
ulrika.risedal@ctc-ab.se
Site Name
Karolinska University Hospital
Department Name
Dermatology Department
Principal Investigator Name
Natalia Kuzmina
Principal Investigator Email
natalia.kuzmina@regionstockholm.se
Contact Person Name
Natalia Kuzmina

France

Earliest CTIS Part Ii Submission Date
04-03-2024
Latest Decision Or Authorization Date
27-04-2026
Number Of Sites
11
Number Of Participants
60

Sites

Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Dermatology Department
Principal Investigator Name
Thierry Passeron
Principal Investigator Email
passeron@unice.fr
Contact Person Name
Thierry Passeron
Contact Person Email
passeron@unice.fr
Site Name
Courlancy Sante
Department Name
Dermatology Department
Principal Investigator Name
Ziad Reguiai
Principal Investigator Email
dr-reguiai@orange.fr
Contact Person Name
Ziad Reguiai
Contact Person Email
dr-reguiai@orange.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Dermatology Department
Principal Investigator Name
Claire Abasq-Thomas
Principal Investigator Email
claire.abasq@chu-brest.fr
Contact Person Name
Claire Abasq-Thomas
Contact Person Email
claire.abasq@chu-brest.fr
Site Name
CHU De Rouen
Department Name
Dermatology Department
Principal Investigator Name
Anne-Benedicte Duval-Modeste
Principal Investigator Email
ab.duval-modeste@chu-rouen.fr
Contact Person Name
Anne-Benedicte Duval-Modeste
Contact Person Email
ab.duval-modeste@chu-rouen.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Dermatology Department
Principal Investigator Name
Julien Seneschal
Principal Investigator Email
julien.seneschal@chu-bordeaux.fr
Contact Person Name
Julien Seneschal
Site Name
Hospital Hotel Dieu
Department Name
Dermatology Department
Principal Investigator Name
Sebastien Barbarot
Principal Investigator Email
sebastien.barbarot@chu-nantes.fr
Contact Person Name
Sebastien Barbarot
Site Name
Hospital Edouard Herriot
Department Name
Dermatology Department
Principal Investigator Name
Denis Jullien
Principal Investigator Email
denis.jullien@chu-lyon.fr
Contact Person Name
Denis Jullien
Contact Person Email
denis.jullien@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Dermatology Department
Principal Investigator Name
Cristina Livideanu
Principal Investigator Email
livideanu.c@chu-toulouse.fr
Contact Person Name
Cristina Livideanu
Contact Person Email
livideanu.c@chu-toulouse.fr
Site Name
Centre D'etude De La Peau Et Du Cheveu
Department Name
Dermatology Department
Principal Investigator Name
Pascal REYGAGNE
Principal Investigator Email
p.reygagne@gmail.com
Contact Person Name
Pascal REYGAGNE
Contact Person Email
p.reygagne@gmail.com
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Dermatology Department
Principal Investigator Name
Catherine Droitcourt
Principal Investigator Email
catherine.droitcourt@chu-rennes.fr
Contact Person Name
Catherine Droitcourt
Site Name
Centre Hospitalier Universitaire De Rouen (additional record)
Department Name
Dermatology Department
Principal Investigator Name
Anne-Benedicte Duval-Modeste
Principal Investigator Email
ab.duval-modeste@chu-rouen.fr
Contact Person Name
Anne-Benedicte Duval-Modeste
Contact Person Email
ab.duval-modeste@chu-rouen.fr

Portugal

Earliest CTIS Part Ii Submission Date
07-03-2024
Latest Decision Or Authorization Date
29-04-2026
Number Of Sites
3
Number Of Participants
18

Sites

Site Name
Centro Hospitalar Universitario Do Porto E.P.E.
Department Name
Dermatology Department
Principal Investigator Name
Tiago Torres
Contact Person Name
Tiago Torres
Site Name
Hospital Garcia De Orta E.P.E.
Department Name
Dermatology Department
Principal Investigator Name
Angela Roda
Principal Investigator Email
angela.roda@hgo.min-saude.pt
Contact Person Name
Angela Roda
Contact Person Email
angela.roda@hgo.min-saude.pt
Site Name
Hospital Cuf Descobertas S.A.
Department Name
Dermatology Department
Principal Investigator Name
Pedro Mendes-Bastos
Principal Investigator Email
pmendesbastos@gmail.com
Contact Person Name
Pedro Mendes-Bastos
Contact Person Email
pmendesbastos@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
07-03-2024
Latest Decision Or Authorization Date
29-04-2026
Number Of Sites
13
Number Of Participants
72

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Dermatology Department
Principal Investigator Name
Ketty Peris
Principal Investigator Email
ketty.peris@unicatt.it
Contact Person Name
Ketty Peris
Contact Person Email
ketty.peris@unicatt.it
Site Name
Humanitas Research Hospital
Department Name
Dermatology Department
Principal Investigator Name
Antonio Costanzo
Principal Investigator Email
acostanzo2000@gmail.com
Contact Person Name
Antonio Costanzo
Contact Person Email
acostanzo2000@gmail.com
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Dermatology Department
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 Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
Dermatology Department
Principal Investigator Name
Anna Balato
Principal Investigator Email
annabalato@yahoo.it
Contact Person Name
Anna Balato
Contact Person Email
annabalato@yahoo.it
Site Name
Azienda Sanitaria Locale Avezzano Sulmona L'Aquila
Department Name
Dermatology Department
Principal Investigator Name
Maria Esposito
Principal Investigator Email
maria.esposito3@univaq.it
Contact Person Name
Maria Esposito
Contact Person Email
maria.esposito3@univaq.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
Dermatology Department
Principal Investigator Name
Luca Bianchi
Principal Investigator Email
luca.bianchi@uniroma2.it
Contact Person Name
Luca Bianchi
Contact Person Email
luca.bianchi@uniroma2.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Dermatology Department
Principal Investigator Name
Giovanni Pellacani
Principal Investigator Email
giovanni.pellacani@uniroma1.it
Contact Person Name
Giovanni Pellacani
Contact Person Email
giovanni.pellacani@uniroma1.it
Site Name
Azienda USL Toscana Centro
Department Name
Dermatology Department
Principal Investigator Name
Francesca Prignano
Principal Investigator Email
francesca.prignano@unifi.it
Contact Person Name
Francesca Prignano
Contact Person Email
francesca.prignano@unifi.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Dermatology Department
Principal Investigator Name
Angelo Valerio Marzano
Principal Investigator Email
angelo.marzano@unimi.it
Contact Person Name
Angelo Valerio Marzano
Contact Person Email
angelo.marzano@unimi.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Dermatology Department
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
Dermatology Department
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 Universitaria Federico II Di Napoli
Department Name
Dermatology Department
Principal Investigator Name
Maddalena Napolitano
Principal Investigator Email
maddy.napolitano@gmail.com
Contact Person Name
Maddalena Napolitano
Contact Person Email
maddy.napolitano@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
26-02-2024
Latest Decision Or Authorization Date
27-04-2026
Number Of Sites
7
Number Of Participants
36

Sites

Site Name
Universitaetsklinikum Schleswig-Holstein
Department Name
Dermatology Department
Principal Investigator Name
Diamant Thaci
Principal Investigator Email
diamant.thaci@uksh.de
Contact Person Name
Diamant Thaci
Contact Person Email
diamant.thaci@uksh.de
Site Name
Thermalsole und Schwefelbad Bentheim GmbH
Department Name
Dermatology Department
Principal Investigator Name
Athanasios Tsianakas
Principal Investigator Email
studien-dermatologie@fk-bentheim.de
Contact Person Name
Athanasios Tsianakas
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Dermatology Department
Principal Investigator Name
Ulrike Blume-Peytavi
Principal Investigator Email
kathrin.hillmann@charite.de
Contact Person Name
Ulrike Blume-Peytavi
Contact Person Email
kathrin.hillmann@charite.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Dermatology Department
Principal Investigator Name
Parnian Firouzi-Memarpuri
Principal Investigator Email
Studien.hautklinik@med.uni-duesseldorf.de
Contact Person Name
Parnian Firouzi-Memarpuri
Site Name
Westfaelische Wilhelms-Universitaet Muenster
Department Name
Dermatology Department
Principal Investigator Name
Nina Magnolo
Principal Investigator Email
nina.magnolo@ukmuenster.de
Contact Person Name
Nina Magnolo
Contact Person Email
nina.magnolo@ukmuenster.de
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Dermatology Department
Principal Investigator Name
Danielle Rogner
Principal Investigator Email
danielle.rogner@mri.tum.de
Contact Person Name
Danielle Rogner
Contact Person Email
danielle.rogner@mri.tum.de
Site Name
Universitaetsklinikum Schleswig-Holstein (additional record)
Department Name
Dermatology Department
Principal Investigator Name
Diamant Thaci
Principal Investigator Email
diamant.thaci@uksh.de
Contact Person Name
Diamant Thaci
Contact Person Email
diamant.thaci@uksh.de

Bulgaria

Earliest CTIS Part Ii Submission Date
07-03-2024
Latest Decision Or Authorization Date
12-05-2026
Number Of Sites
5
Number Of Participants
36

Sites

Site Name
Diagnostic Consultation Center XX-Sofia EOOD
Principal Investigator Name
Toma Tomov
Principal Investigator Email
toma_tomov2015@abv.bg
Contact Person Name
Toma Tomov
Contact Person Email
toma_tomov2015@abv.bg
Site Name
Diagnostic-Consultative Center Alexandrovska EOOD
Principal Investigator Name
Snejina Vassileva
Principal Investigator Email
snejina.vassileva@gmail.com
Contact Person Name
Snejina Vassileva
Contact Person Email
snejina.vassileva@gmail.com
Site Name
Dkc Fokus-5 Lzip OOD
Principal Investigator Name
Grisha Mateev
Principal Investigator Email
grisha_mateev@yahoo.com
Contact Person Name
Grisha Mateev
Contact Person Email
grisha_mateev@yahoo.com
Site Name
Umbal - Prof. D-R Stoyan Kirkovich AD
Department Name
Clinic of Skin and Venereal diseases
Principal Investigator Name
Evgeniya Hristakieva
Principal Investigator Email
ehristakieva@gmail.com
Contact Person Name
Evgeniya Hristakieva
Contact Person Email
ehristakieva@gmail.com
Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
Clinic of Skin and Venereal diseases
Principal Investigator Name
Teodor Aleksiev
Principal Investigator Email
t_aleksiev91@abv.bg
Contact Person Name
Teodor Aleksiev
Contact Person Email
t_aleksiev91@abv.bg

Sponsor

Primary sponsor

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

Contract research organisations

Name
Endpoint Clinical Inc.
Responsibilities
sponsor duties code 3
Name
WCG Clinical Inc.
Responsibilities
Training, Cardiac Adjudication
Name
Cytel Inc.
Responsibilities
External Data Monitoring Committee

Third parties

  • {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"patient recruitment","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsor duties codes 6, 7","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsor duties code 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Training, Cardiac Adjudication","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"ePro","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"External Data Monitoring Committee","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Imaging","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Upadacitinib
Active Substance
UPADACITINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Authorisation Status
Authorised (prodAuthStatus 1 for product entries)
Starting Dose
15 mg
Dose Levels
15 mg, 30 mg
Frequency
once daily (QD)
Maximum Dose
30 mg
Dose Escalation Increase
Initial 15 mg QD and 30 mg QD (dose escalation to 30 mg QD for non-responders; dose reduction to 15 mg QD for sustained responders)
Investigational Product Name
Upadacitinib Placebo
Modality
Other

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