Clinical trial • Phase III • Immunology|Dermatology

UPADACITINIB for Atopic dermatitis | Moderate to severe atopic dermatitis

Phase III trial of UPADACITINIB for Atopic dermatitis | Moderate to severe atopic dermatitis.

Overview

Trial Therapeutic Area
Immunology|Dermatology
Trial Disease
Atopic dermatitis | Moderate to severe atopic dermatitis
Trial Stage
Phase III
Drug Modality
Small molecule|Monoclonal antibody
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
09-07-2024
First CTIS Authorization Date
22-10-2024

Trial design

Randomised, open-label, dupilumab (solution for injection; subcutaneous) used as the reference comparator at label-indicated dose and frequency (exact numeric dose/schedule not specified in part i documentation).-controlled Phase III trial in Bulgaria, Austria, Germany and others.

Randomised
Yes
Open Label
Yes
Comparator
Dupilumab (solution for injection; subcutaneous) used as the reference comparator at label-indicated dose and frequency (exact numeric dose/schedule not specified in Part I documentation).
Target Sample Size
475
Trial Duration For Participant
1120

Eligibility

Recruits 475 paediatric patients.

Vulnerable Population
Pediatric population (children aged 2 to <12 years). Parental/guardian informed consent is required; assent is obtained from children using age-appropriate assent tools (documents available for age bands such as 2-5 years and 6-11 years and older assent versions). Country-specific parent/guardian ICFs and assent materials are provided (multiple languages and country versions listed in recruitment/ICF documents).

Inclusion criteria

  • {"criterion_text":"- Subject must be a pediatric individual 2 to < 12 years old at Screening and Baseline Visit. Note: Only subjects 6 to < 12 years of age will be enrolled in the US. Outside of the US, subjects 2 to < 6 years of age may be enrolled where allowed."}
  • {"criterion_text":"- Subject must be at a minimum weight of 10 kg and weight and height > 5th percentile for their age according to local standard growth charts at the Baseline Visit."}
  • {"criterion_text":"- Subject must meet the following disease activity criteria at Baseline Visit: • EASI score ≥ 16; • vIGA-AD score ≥ 3 (Note: In countries where dupilumab is only approved for severe AD, subjects to be included in the Randomized Cohort should have severe AD [vIGA-AD = 4]); and • ≥ 10% BSA of AD involvement. • Baseline weekly average of daily WIS (patient-reported) or WSI-NRS (caregiver-reported) ≥ 4. The Baseline weekly average will be calculated from the 7 consecutive days immediately preceding the Baseline Visit. A minimum of 4 daily scores out of the 7 days is needed."}
  • {"criterion_text":"- Subject must satisfy at least one of the following criteria (Note: More than 1 criterion may apply to an individual subject. All applicable criteria for each individual subject should be reported.): • To be included in the Randomized Cohort (Note: Subjects must have severe AD [vIGA-AD = 4] in countries where dupilumab is approved only for severe AD): a. [For all countries except US] Documented history of inadequate response or intolerance to TCS and/or TCI OR for whom use of one or more of these topical treatments is medically inadvisable (e.g., high disease burden, SCORAD > 50, EASI score > 21, or vIGAAD> 3). Note: Enrolled subjects eligible under Criterion 6a will be capped at 50% of the total enrollment. b. For dupilumab-naïve subjects: History of inadequate response to a systemic therapy for AD other than dupilumab or oral corticosteroids or for whom the available systemic treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks). c. History of inadequate response to 2 or more courses of oral corticosteroid therapy given for ≥ 14 days within 6 months prior to Screening or history of oral corticosteroid rebound, defined as recurrence of AD symptoms within 4 months after its discontinuation. d. For dupilumab-exposed subjects: Prior exposure to dupilumab without documented history of inadequate response or intolerance (i.e., discontinuation of dupilumab for a non-medical reason, such as, but not limited to, non-coverage or loss of coverage for the drug by health insurance, or other logistic challenges [not safety- or efficacy-related] precluding the subject's continued access to dupilumab). • To be included in the Dupi-IR/Dupi-Medically Inadvisable Cohort: • Previous inadequate response or intolerance to dupilumab OR • Dupilumab is medically inadvisable (e.g., allergy to a component of dupilumab, etc.) AND a documented history of inadequate response or intolerance to TCS and/or TCI."}
  • {"criterion_text":"- Subjects with periocular AD involvement must be willing to undergo preliminary ophthalmology assessment prior to the Baseline Visit."}

Exclusion criteria

  • {"criterion_text":"- Subjects who have used topical treatments for AD (except for topical emollient treatments) including but not limited to TCS, TCI, or topical PDE-4 inhibitors, within 7 days of the Baseline Visit."}
  • {"criterion_text":"- Subjects who have used any the following prohibited concomitant AD treatments within the specified timeframes below prior to the Baseline Visit: • Systemic therapy for AD, including but not limited to corticosteroids, methotrexate, cyclosporine, azathioprine, PDE-4 inhibitors, IFN-γ, and mycophenolate mofetil within 4 weeks; • Dupilumab within 8 weeks; • Targeted biologic treatments (other than dupilumab) within 5 half-lives (if known) or within 12 weeks, whichever is longer; • Phototherapy treatment, laser therapy, tanning booth, or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks"}
  • {"criterion_text":"- Subjects who have used any oral or topical JAK inhibitor (including but not limited to baricitinib, upadacitinib, ruxolitinib, and delgocitinib) anytime before the study"}
  • {"criterion_text":"- Known history of retinal detachment, previous cataract surgery, previous significant ocular trauma, or a known congenital ocular abnormality."}
  • {"criterion_text":"- For Randomized Cohort: diagnosed active parasitic infection; suspected or high risk of parasitic infection, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percentage of Participants Achieving a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) at Week 16 (other than US)","definition_or_measurement_approach":"Proportion of subjects achieving EASI 75 (≥75% reduction from baseline in EASI score) at Week 16 in the ITT population (endpoint applies to countries other than US)."}
  • {"endpoint_text":"- Achievement of validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) 0 or 1 with a reduction from Baseline of ≥ 2 points at Week 16 (US and China only, descriptive)","definition_or_measurement_approach":"Proportion of subjects achieving vIGA-AD 0 or 1 with a reduction of ≥2 points from baseline at Week 16 in the ITT population (specified as the primary endpoint for US and China; descriptive)."}

Secondary endpoints

  • {"endpoint_text":"- Percentage of participants achieving validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 (on a 5-point scale) with a reduction from Baseline of ≥ 2 Points at Week 16 (other than US and China)","definition_or_measurement_approach":"Proportion achieving vIGA-AD 0/1 with ≥2-point improvement at Week 16 (outside US/China)."}
  • {"endpoint_text":"- Percentage of participants achieving a 50% reduction from Baseline in EASI score (EASI 50) at Week 16","definition_or_measurement_approach":"Proportion achieving ≥50% reduction in EASI from baseline at Week 16."}
  • {"endpoint_text":"- Percentage of participants achieving Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 (on a 5-point scale) with a reduction from Baseline of ≥ 2 Points at Week 52","definition_or_measurement_approach":"Proportion achieving vIGA-AD 0/1 with ≥2-point reduction at Week 52."}
  • {"endpoint_text":"- Percentage of participants achieving Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 (on a 5-point scale) with a reduction from Baseline of ≥ 2 Points at Week 160","definition_or_measurement_approach":"Proportion achieving vIGA-AD 0/1 with ≥2-point reduction at Week 160 (long-term outcome)."}
  • {"endpoint_text":"- Percentage of participants achieving an improved (reduced) Patient Oriented Eczema Measure (POEM) of ≥ 4 points at Week 16 from participants with POEM ≥ 4 at Baseline","definition_or_measurement_approach":"Proportion of participants with baseline POEM ≥4 who achieve ≥4-point improvement at Week 16."}
  • {"endpoint_text":"- Percentage of for participants ≥ 4 years of age with a Baseline Children's Dermatology Life Quality Index (CDLQI) score of >1 participants achieving a CDLQI score of 0 or 1 at Week 8","definition_or_measurement_approach":"Proportion of participants ≥4 yrs with baseline CDLQI>1 achieving CDLQI 0 or 1 at Week 8."}
  • {"endpoint_text":"- Percentage of for participants ≥ 4 years of age with a Baseline Children's Dermatology Life Quality Index (CDLQI) score of >1 participants achieving a CDLQI score of 0 or 1 at Week 16","definition_or_measurement_approach":"Proportion of participants ≥4 yrs with baseline CDLQI>1 achieving CDLQI 0 or 1 at Week 16."}
  • {"endpoint_text":"- Percent change in Scoring Atopic Dermatitis (SCORAD) from Baseline at Week 16","definition_or_measurement_approach":"Percent change in SCORAD score from baseline to Week 16."}
  • {"endpoint_text":"- Use of topical or systemic rescue therapy from Baseline to Week 16","definition_or_measurement_approach":"Recording whether topical or systemic rescue treatments were used between baseline and Week 16."}
  • {"endpoint_text":"- Number of days on rescue topical corticosteroid or topical calcineurin inhibitor from Baseline to Week 16","definition_or_measurement_approach":"Count of days participants received rescue topical corticosteroid or topical calcineurin inhibitor from baseline through Week 16."}
  • {"endpoint_text":"- Percentage of participants achieving a EASI 75 response at Week 16 for low dose Dupilumab daily adult equivalent dose","definition_or_measurement_approach":"Proportion achieving EASI 75 at Week 16 in subgroup treated with low-dose dupilumab adult-equivalent daily dose."}
  • {"endpoint_text":"- Achievement of EASI 75 response at Week 16 (US)","definition_or_measurement_approach":"Proportion achieving EASI 75 at Week 16 in US cohort (per protocol definitions)."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
475
Recruitment Window Months
66
Consent Approach
Parental/guardian informed consent is required for all pediatric participants; age-appropriate assent is sought from children using dedicated assent tools (documents available for age bands such as 2-5 years and 6-11 years and older assent versions). Country- and language-specific parent/guardian ICFs and assent materials are provided (multiple country versions listed in the public documents). ICF and assent documentation examples include English and country-language versions (e.g., Bulgarian, German, French, Italian, Spanish, Portuguese, Dutch, Polish, Hungarian, Slovak, Croatian).

Methods

  • Country-specific site-based recruitment through participating hospitals/dermatology and pediatric clinics (detailed site lists per country provided in Part II).
  • Printed recruitment materials: recruitment brochures and flyers (country-specific versions listed for DE, AT, BG, IT, ES, PT, NL, SK, HR, PL, HU, FR).
  • Digital advertising: digital ad visuals and animated ICF/storyboard materials for online promotion (country-specific digital assets listed).
  • Multimedia: animated ICF storyboards and video storyboards to explain study participation to parents and children.
  • Direct outreach and patient retention support via third-party vendor Clinical Trial Media (listed under sponsor third parties for patient recruitment and retention).

Geography

Total Number Of Sites
57
Total Number Of Participants
475

Bulgaria

Earliest CTIS Part Ii Submission Date
17-10-2024
Latest Decision Or Authorization Date
28-10-2024
Processing Time Days
11
Number Of Sites
2
Number Of Participants
15

Sites

Site Name
Alexandrovska University Hospital
Department Name
Clinic of Clinical allergology
Contact Person Name
Maria Staevska
Contact Person Email
mari66sta@gmail.com
Site Name
Medical Center Kordis OOD
Contact Person Name
Dimitar Gospodinov
Contact Person Email
dkg@abv.bg

Austria

Earliest CTIS Part Ii Submission Date
17-10-2024
Latest Decision Or Authorization Date
23-10-2024
Processing Time Days
6
Number Of Sites
3
Number Of Participants
15

Sites

Site Name
Medical University Of Graz
Department Name
Universitaetsklinik fuer Dermatologie und Venerologie
Contact Person Name
Barbara Binder
Contact Person Email
barbara.binder@medunigraz.at
Site Name
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department Name
Universitaetsklinik fuer Kinder- und Jugendheilkunde
Contact Person Name
Christine Wagger
Contact Person Email
c.wagger@salk.at
Site Name
Medical University Of Vienna
Department Name
Universitaetsklinik fuer Kinder- und Jugendheilkunde
Contact Person Name
Zsolt Szepfalusi

Germany

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
24-10-2024
Processing Time Days
13
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Thermalsole und Schwefelbad Bentheim GmbH
Department Name
Klinisches Studienzentrum
Contact Person Name
Athanasios Tsianakas
Site Name
Universitaet Muenster
Department Name
Klinik für Hautkrankheiten
Contact Person Name
Nina Magnolo
Contact Person Email
Nina.Magnolo@ukmuenster.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Department of Dermatology
Contact Person Name
Ulrike Blume-Peytavi
Contact Person Email
crc-studien@charite.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Hautklinik
Contact Person Name
Michael Sticherling
Contact Person Email
studien.de@uk-erlangen.de

Italy

Earliest CTIS Part Ii Submission Date
15-10-2024
Latest Decision Or Authorization Date
25-10-2024
Processing Time Days
10
Number Of Sites
2
Number Of Participants
15

Sites

Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Dermatology
Contact Person Name
Iria Neri
Contact Person Email
iria.neri@aosp.bo.it
Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
UOC Dermatology
Contact Person Name
Dario Francesco D'Urso
Contact Person Email
dariofdurso@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
09-10-2024
Latest Decision Or Authorization Date
22-10-2024
Processing Time Days
13
Number Of Sites
6
Number Of Participants
25

Sites

Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Servicio de Dermatología
Contact Person Name
Minia Campos Domínguez
Contact Person Email
miniacampos@gmail.com
Site Name
Hospital Sant Joan De Deu Barcelona
Department Name
Servicio de Dermatología
Contact Person Name
Asuncion Vicente Villa
Contact Person Email
asuncion.vicente@sjd.es
Site Name
Hospital General Universitario De Valencia
Department Name
Servicio de Dermatología
Contact Person Name
Altea Esteve Martinez
Contact Person Email
alteamarsa@hotmail.com
Site Name
Hospital Universitario Miguel Servet
Department Name
Servicio de Dermatología
Contact Person Name
Yolanda Gilaberte Calzada
Site Name
Hospital Universitario La Paz
Department Name
Servicio de Dermatología
Contact Person Name
Raul De Lucas Laguna
Contact Person Email
rauldelucas@gmail.com
Site Name
Hospital General Universitario Gregorio Maranon (additional listed sites)
Department Name
Servicio de Dermatología (other Spanish sites listed in part II)

Hungary

Earliest CTIS Part Ii Submission Date
10-10-2024
Latest Decision Or Authorization Date
24-10-2024
Processing Time Days
14
Number Of Sites
3
Number Of Participants
15

Sites

Site Name
DermaMed Research Kft.
Department Name
DermaMed Research Kft.
Contact Person Name
Piroska Dosa
Contact Person Email
dermamed.research@gmail.com
Site Name
University Of Szeged
Department Name
Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati es Allergologiai Klinika
Contact Person Name
Zsanett Csoma
Contact Person Email
csoma.zsanett@med.u-szeged.hu
Site Name
University Of Debrecen
Department Name
Klinikai Kozpont, Borgyogyaszati Klinika
Contact Person Name
Andrea Szegedi
Contact Person Email
aszegedi@med.unideb.hu

France

Earliest CTIS Part Ii Submission Date
14-10-2024
Latest Decision Or Authorization Date
22-10-2024
Processing Time Days
8
Number Of Sites
10
Number Of Participants
40

Sites

Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service de Dermatologie
Contact Person Name
Sebastien Barbarot
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de Dermatologie
Contact Person Name
Nathalia Bellon
Contact Person Email
nathalia.bellon@aphp.fr
Site Name
Pellegrin Hospital
Department Name
Service de Dermatologie
Contact Person Name
Sorilla Prey
Contact Person Email
sorilla.prey@chu-bordeaux.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Service de Dermatologie
Contact Person Name
Justine Pasteur
Site Name
Centre Hospitalier Victor Dupouy
Department Name
Service de Dermatologie
Contact Person Name
Emmanuel Mahe
Contact Person Email
emmanuel.mahe@ch-argenteuil.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Service de Dermatologie
Contact Person Name
Ali Dadban
Contact Person Email
dadban.ali@chu-amiens.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Service de Dermatologie
Contact Person Name
Maella Severino-Freire
Site Name
CHRU De Nancy
Department Name
Service de Dermatologie
Contact Person Name
Anne-Claire Bursztejn
Contact Person Email
ac.bursztejn@chru-nancy.fr
Site Name
Pellegrin Hospital (additional listed French sites)
Department Name
Service de Dermatologie
Site Name
Centre Hospitalier Universitaire De Nantes (additional listed French sites)
Department Name
Service de Dermatologie

Slovakia

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
22-10-2024
Processing Time Days
11
Number Of Sites
5
Number Of Participants
25

Sites

Site Name
Narodny Ustav Detskych Chorob
Department Name
Dermatovenerology Clinic
Contact Person Name
Dusan Buchvald
Contact Person Email
marcela.remenarova@gmail.com
Site Name
Fakultna Nemocnica Trnava
Department Name
Dermatovenerologicke oddelenie
Contact Person Name
Peter Kozub
Contact Person Email
peter.kozub.derm@gmail.com
Site Name
Univerzitna Nemocnica Martin
Department Name
Klinika deti a dorastu
Contact Person Name
Milos Jesenak
Contact Person Email
lucia.jedlickova@unm.sk
Site Name
Univerzitna nemocnica L. Pasteura Kosice
Department Name
Dermatovenerology clinic
Contact Person Name
Janette Baloghova
Contact Person Email
janette.baloghova@unlp.sk
Site Name
Alersa s.r.o.
Department Name
Ambulancia klinickej imunologie a alergologie
Contact Person Name
Daniela Safcakova
Contact Person Email
dsafcakova@gmail.com

Croatia

Earliest CTIS Part Ii Submission Date
16-10-2024
Latest Decision Or Authorization Date
28-10-2024
Processing Time Days
12
Number Of Sites
5
Number Of Participants
25

Sites

Site Name
Klinika Za Djecje Bolesti Zagreb
Department Name
Department of pediatrics
Contact Person Name
Suzana Ozanic Bulic
Contact Person Email
suzanaozanic@hotmail.com
Site Name
Poliklinika Solmed d.o.o.
Department Name
Dermatology
Contact Person Name
Iva Blajic
Contact Person Email
info@solmed-clinic.com
Site Name
Poliklinika Dermaplus
Department Name
Dermatovenereology
Contact Person Name
Lena Kotrulja
Contact Person Email
info@dermaplus.hr
Site Name
Specijalna Bolnica Medico
Department Name
Department of dermatovenereology
Contact Person Name
Sandra Peternel
Contact Person Email
medico@medico.hr
Site Name
KBC Split
Department Name
Department of dermatology and venereology
Contact Person Name
Ranka Ivanisevic
Contact Person Email
der.poliklinika@kbsplit.hr

Poland

Earliest CTIS Part Ii Submission Date
10-10-2024
Latest Decision Or Authorization Date
11-12-2024
Processing Time Days
62
Number Of Sites
12
Number Of Participants
35

Sites

Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Contact Person Name
Aleksandra Badzian
Contact Person Email
a.badzian@naszlekarz.pl
Site Name
Provita Sp. z o.o.
Contact Person Name
Anita Lewartowska-Bialek
Site Name
NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL
Contact Person Name
Adam Wroński
Contact Person Email
adam.wronski@dermal.pl
Site Name
Klinika Ambroziak Sp. z o.o.
Contact Person Name
Justyna Skibińska
Site Name
Clinical Research Group Sp. z o.o.
Contact Person Name
Kamila Padlewska
Contact Person Email
kamila@padlewska.com
Site Name
Royalderm Agnieszka Nawrocka
Contact Person Name
Witold Owczarek
Contact Person Email
witold.owczarek@dermedicus.pl
Site Name
Klinika Osipowicz & Turkowski Sp. z o.o.
Contact Person Name
Katarzyna Osipowicz
Contact Person Email
drkatarzynaosipowicz@gmail.com
Site Name
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Contact Person Name
Aleksandra Okuniewska
Contact Person Email
a.okuniewska@pihouse.pl
Site Name
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
Contact Person Name
Urszula Jedynak-Wąsowicz
Contact Person Email
ulaj@mp.pl
Site Name
Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus
Contact Person Name
Ewa Springer
Contact Person Email
e.springer@wp.pl
Site Name
Other listed Polish investigator sites
Site Name
Additional listed Polish site

Netherlands

Earliest CTIS Part Ii Submission Date
23-10-2024
Latest Decision Or Authorization Date
23-10-2024
Number Of Sites
2
Number Of Participants
15

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Contact Person Name
Heleen de Koning
Contact Person Email
dermaresearch@erasmusmc.nl
Site Name
Stichting Amsterdam UMC
Contact Person Name
Phyllis Spuls
Contact Person Email
poli.dermatologie@amc.nl

Portugal

Earliest CTIS Part Ii Submission Date
23-08-2024
Latest Decision Or Authorization Date
25-10-2024
Processing Time Days
63
Number Of Sites
3
Number Of Participants
15

Sites

Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Department Name
Dermatology
Contact Person Name
Alberto Mota
Contact Person Email
amota@ulssjoao.min-saude.pt
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Dermatology
Contact Person Name
Susana Machado
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Dermatology
Contact Person Name
Leonor Ramos
Contact Person Email
leonoricr@gmail.com

Sponsor

Primary sponsor

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

Contract research organisations

Name
Cytel Inc.
Responsibilities
Data Monitoring Committee
Name
Labcorp Central Laboratory Services SARL
Responsibilities
Central laboratory services
Name
Veeva Systems Inc.
Responsibilities
Clinical data management / CDMS support
Name
Clinical Trial Media Inc.
Responsibilities
Patient recruitment and retention
Name
WCG Clinical Inc.
Responsibilities
Adjudication committees (Cardiovascular, GI perforation)
Name
WCG Clinical - Trifecta
Responsibilities
Rater training
Name
Signant Health Global LLC
Responsibilities
eCOA questionnaires
Name
Iqvia Pharma Inc.
Responsibilities
IRT support

Third parties

  • {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"Data Monitoring Committee","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central laboratory services (sponsor duties code 4)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"Clinical data management system support (CDMS)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"Patient Recruitment and Retention","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Cardiovascular and Gastrointestinal Perforation Adjudication Committees","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical - Trifecta","duties_or_roles":"Rater Training","organisation_type":"SME"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eCOA Questionnaires","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Iqvia Pharma Inc.","duties_or_roles":"Interactive Response Technology (IRT) support","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Upadacitinib
Active Substance
UPADACITINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
Oral
Starting Dose
7.5 mg and 15 mg (adult-equivalent) daily
Dose Levels
7.5 mg; 15 mg (adult-equivalent daily doses)
Frequency
Once daily
Investigational Product Name
Dupilumab
Active Substance
DUPILUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
Subcutaneous injection
Dose Levels
Label-indicated dose and frequency (reference arm); specific mg not specified in Part I documentation
Frequency
Per label-indicated dosing schedule

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