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A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis (Heads Up)

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Upadacitinib
Dupilumab
Placebo to dupilumab
Placebo to upadacitinib
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Upadacitinib, ABT-494, Dupilumab, Atopic Dermatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participant has active moderate to severe atopic dermatitis (AD) defined by Eczema Area and Severity Index (EASI) ≥ 16, Investigator's Global Assessment (IGA) ≥ 3, ≥ 10% body surface area (BSA) of AD involvement at the Screening and Baseline Visits, and Baseline weekly average of daily Worst Pruritus NRS ≥ 4.
  • Participant is a candidate for systemic therapy or have recently required systemic therapy for AD.

Exclusion Criteria:

  • Participant has prior exposure to Janus Kinase (JAK) inhibitor.
  • Participant has prior exposure to dupilumab.
  • Participant is unable or unwilling to discontinue current AD treatments prior to the study.
  • Participant has requirement of prohibited medications during the study.
  • Participant has other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of AD lesions.
  • Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.

Sites / Locations

  • Clinical Research Center AL /ID# 210277
  • University of Arkansas for Medical Sciences /ID# 211688
  • Tien Q Nguyen MD, Inc /ID# 208934
  • UCSF Fresno /ID# 213253
  • Jonathan Corren, MD. INC /ID# 208987
  • California Allergy and Asthma Medical Group /ID# 213680
  • Dermatology Research Associates /ID# 209097
  • Los Angelos Cataract Center /ID# 208524
  • Dermatology Clinical Trials /ID# 214622
  • UC Davis Health /ID# 209285
  • Ucsd /Id# 208990
  • Clinical Science Institute /ID# 211022
  • The Community Research of South Florida /ID# 211145
  • Miami Dermatology and Laser Institute /ID# 212938
  • Florida International Rsrch cr /ID# 211562
  • Progressive Medical Research /ID# 211994
  • GCP Research /ID# 216020
  • Clinical Research Trials of Florida, Inc. /ID# 210751
  • Integrated Clinical Research LLC /ID# 208831
  • Georgia Pollens Clinical Research Centers, Inc /ID# 211092
  • Meridian Clinical Research Dermatology /ID# 213251
  • Northwestern University Feinberg School of Medicine /ID# 208680
  • Medical Dermatology Associates of Chicago /ID# 210265
  • Sneeze, Wheeze, & Itch Associates, LLC /ID# 212058
  • Dawes Fretzin, LLC /ID# 209187
  • Beacon Clinical Research, LLC /ID# 209280
  • Clarkston Skin Research /ID# 208739
  • Henry Ford Health System /ID# 208741
  • Clinical Research Institute, Inc /ID# 210852
  • Allergy, Asthma & Immunology Associates, PC /ID# 213481
  • Skin Specialists, PC /ID# 208843
  • Dartmouth-Hitchcock Medical Center /ID# 213727
  • Montefiore Medical Center /ID# 209647
  • Forest Hills Dermatology Group /ID# 209249
  • Wake Forest Univ HS /ID# 208892
  • Univ Hosp Cleveland /ID# 208852
  • The Ohio State University /ID# 209254
  • Southside Dermatology /ID# 212004
  • Oregon Medical Res Center PC /ID# 208807
  • Oregon Health and Science University /ID# 208809
  • Medical University of South Carolina /ID# 211054
  • Clinical Research Solutions, LLC /ID# 212542
  • Orion Clinical Research /ID# 208765
  • DiscoveResearch, Inc. /ID# 213171
  • Epiphany Dermatology - Fort Worth /ID# 211187
  • Sante Clinical Research /ID# 212970
  • Stephen Miller, MD PA /ID# 210071
  • Sugar Land Allergy, Asthma, and Immunology Center /ID# 211153
  • University of Utah /ID# 209001
  • Clinical Research Partners, LLC /ID# 212262
  • Premier Clinical Research /ID# 212142
  • West Virginia Research Inst /ID# 212730
  • Holdsworth House Medical Practice /ID# 214565
  • The Skin Hospital /ID# 214401
  • Veracity Clinical Research /ID# 211134
  • Sinclair Dermatology /ID# 209395
  • Burswood Dermatology /ID# 214875
  • Kirk Barber Research, CA /ID# 209504
  • Dermatology Research Institute Inc. /ID# 210942
  • Dr. Chih-ho Hong Medical Inc. /ID# 211032
  • Enverus Medical Research /ID# 209503
  • Dr. Wei Jing Loo Medicine Prof /ID# 211400
  • Lynderm Research Inc. /ID# 209505
  • DermEdge Research Inc. /ID# 211122
  • Niakosari Medicine Professional Corporation /ID# 211401
  • K. Papp Clinical Research /ID# 209509
  • Dre Angelique Gagne-Henley M.D. inc. /ID# 209498
  • DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 209935
  • Djecja bolnica Srebrnjak /ID# 209939
  • Klinicki bolnicki centar Zagreb /ID# 209976
  • Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 209937
  • Fakultni Nemocnice Brno /ID# 212968
  • FN Hradec Kralove /ID# 209116
  • Nemocnice Jihlava, prispevkova organizace /ID# 209131
  • Fakultni nemocnice Ostrava /ID# 209117
  • Fakultni Nemocnice v Motole /ID# 209209
  • Keski-pohjanmaa Central Hospital /ID# 209534
  • Oulu University Hospital /ID# 208961
  • Mikkeli Central Hospital /ID# 210125
  • Pihlajalinna Turku /ID# 209599
  • CHRU Lille - Hopital Claude Huriez /ID# 209317
  • CHU de Nantes - Hotel Dieu /ID# 208974
  • Charles Nicolle CHU Rouen /ID# 208973
  • Hopital de la Timone /ID# 211245
  • Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2 /ID# 213374
  • Polyclinique Courlancy /ID# 208975
  • Hopital Larrey - CHU de Toulouse /ID# 208976
  • Universitatsklinikum Munster /ID# 210935
  • Gemeinschaftspraxis /ID# 211174
  • Hautklinik Klinikum Darmstadt /ID# 210938
  • Universitaetsklinikum Frankfurt /ID# 210934
  • Medizinische Hochschule Hannover /ID# 210939
  • TU Uniklinik Munchen /ID# 210937
  • Oroshazi Korhaz /ID# 210150
  • Uno Medical Trials Kft /ID# 211177
  • Debreceni Egyetem Klinikai Kozpont /ID# 210893
  • Somogy Megyei Kaposi Mor Oktat /ID# 210149
  • Pecsi Tudomanyegyetem Klinikai l.sz. Belgyogyaszati Klinika /ID# 210892
  • St Vincent's University Hosp /ID# 208441
  • University Hospital Waterford /ID# 208442
  • HaEmek Medical Center /ID# 210153
  • Rabin Medical Center /ID# 210012
  • Sheba Medical Center /ID# 210013
  • Ichilov Medical Center /ID# 210014
  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 210632
  • IBD Center - IRCCS Istituto Clinico Humanitas /ID# 215726
  • A.O. Policlinico Sant'Orsola Malpighi /ID# 209111
  • A.O.U. di Brescia /ID# 209115
  • Ospedale San Giovanni di Dio /ID# 209109
  • AO Univ di Modena /ID# 209110
  • Policlinico Univ Tor Vergata /ID# 209112
  • Hospital Sultan Ismail /ID# 211037
  • Hospital Pakar Sultanah Fatimah /ID# 210185
  • UKM Medical Centre /ID# 209178
  • University Malaya Med Ctr /ID# 208861
  • Hospital Pulau Pinang /ID# 210212
  • Hospital Putrajaya /ID# 209177
  • Bravis Ziekenhuis /ID# 208584
  • Academisch Medisch Centrum /ID# 208578
  • Centrum Oosterwal /ID# 209641
  • Universitair Medisch Centrum Groningen /ID# 208583
  • Erasmus Medisch Centrum /ID# 208582
  • Universitair Medisch Centrum Utrecht /ID# 208579
  • Optimal Clinical Trials Ltd /ID# 209475
  • Clinical Trials NZ /ID# 215590
  • Wellington Hospital (Capital and Coast District Health Board) /ID# 215001
  • St. Olavs Hospital HF /ID# 209137
  • Universitetssykehuset N-Norge, Harstad /ID# 209105
  • Universitetssykehuset N-Norge, Tromso /ID# 209103
  • Szpital Uniwersytecki nr 1 im. dr. A. Jurasza w Bydgoszczy /ID# 211103
  • Dermoklinika Medical Center /ID# 211026
  • Pratia MCM Krakow /ID# 207444
  • Klinika Ambroziak Sp. z o.o. /ID# 207443
  • Royalderm Agnieszka Nawrocka /ID# 211015
  • ClinicMed Daniluk, Nowak Sp.j. /ID# 211112
  • National Skin Centre /ID# 208775
  • National University Hospital /ID# 208774
  • Singapore General Hospital /ID# 208776
  • Hospital Universitario de Bellvitge /ID# 207063
  • Hospital Universitario Dr. Negrin /ID# 208969
  • Hospital de Manises /ID# 207062
  • Complejo Hospitalario Universitario de Pontevedra /ID# 207139
  • Hospital Universitario Arnau Vilanova /ID# 207065
  • Hospital Universitario y Politecnico La Fe /ID# 207064
  • Skanes Universitetssjukhus /ID# 206783
  • Karolinska University Hospital /ID# 207909
  • China Medical University Hosp /ID# 209770
  • National Taiwan University Hospital /ID# 208309
  • Chung Shan Medical University /ID# 208311
  • Taipei Municipal Wan Fang Hospital /ID# 209987
  • Military Hospital of Military-Medical Clinical Center of Southern Region /ID# 210435
  • Kyiv City Clinical Skin and Venereal Hospital /ID# 210755
  • ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 210434
  • Royal Alex Childrens County Hospital /ID# 209709
  • Victoria Hospital /ID# 209853
  • Royal Hospital for Children /ID# 210451
  • The Royal Free Hospital /ID# 208659
  • Guy's and St Thomas' NHS Found /ID# 208881
  • Cardiff & Vale University Health Board /ID# 209745

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Upadacitinib 30 mg QD

Dupilumab 300 mg EOW

Arm Description

Participants will receive 30 mg upadacitinib orally once a day (QD) up to Week 24 and placebo to dupilumab by subcutaneous injection every other week from Baseline to Week 22.

Participants will receive a loading dose of 600 mg dupilumab by subcutaneous (SC) injection on Day 1 followed by 300 mg dupilumab SC every other week (EOW) until Week 22 and placebo to upadacitinib orally QD up to Week 24.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 16
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

Secondary Outcome Measures

Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at Week 16
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). The percent change from Baseline was calculated from a rolling weekly average; a negative change from Baseline indicates improvement.
Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at Week 4
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). The percent change from Baseline was calculated from a rolling weekly average; a negative change from Baseline indicates improvement.
Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score at Week 2
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at Week 1
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). The percent change from Baseline was calculated from a rolling weekly average; a negative change from Baseline indicates improvement.
Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 16
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).

Full Information

First Posted
November 9, 2018
Last Updated
January 10, 2022
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03738397
Brief Title
A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis
Acronym
Heads Up
Official Title
A Phase 3b Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 21, 2019 (Actual)
Primary Completion Date
August 27, 2020 (Actual)
Study Completion Date
December 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate upadacitinib compared to dupilumab (Dupixent®) in adults with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
Detailed Description
The study is comprised of a 35-day screening period, a 24-week double-blinded treatment period, and a follow-up visit 12 weeks after the last dose. Participants who complete Week 24 have the option to enroll into an open-label study (Study M19-850; NCT04195698) of upadacitinib 30 mg once daily and receive treatment with upadacitinib for an additional 52 weeks. Participants who meet eligibility criteria will be randomized in a 1:1 ratio to receive either upadacitinib or dupilumab. Randomization will be stratified by Baseline disease severity (Validated Investigator Global Assessment scale for Atopic Dermatitis [vIGA-AD] score of moderate [3] versus severe [4]) and age (<40, ≥ 40 to < 65, ≥ 65 years).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Upadacitinib, ABT-494, Dupilumab, Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
692 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Upadacitinib 30 mg QD
Arm Type
Experimental
Arm Description
Participants will receive 30 mg upadacitinib orally once a day (QD) up to Week 24 and placebo to dupilumab by subcutaneous injection every other week from Baseline to Week 22.
Arm Title
Dupilumab 300 mg EOW
Arm Type
Experimental
Arm Description
Participants will receive a loading dose of 600 mg dupilumab by subcutaneous (SC) injection on Day 1 followed by 300 mg dupilumab SC every other week (EOW) until Week 22 and placebo to upadacitinib orally QD up to Week 24.
Intervention Type
Biological
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
ABT-494, RINVOQ®
Intervention Description
Extended release tablet
Intervention Type
Biological
Intervention Name(s)
Dupilumab
Other Intervention Name(s)
Dupixent®
Intervention Description
Dupilumab is administered as a subcutaneous (SC) injection
Intervention Type
Drug
Intervention Name(s)
Placebo to dupilumab
Intervention Description
Placebo administered as a subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo to upadacitinib
Intervention Description
Tablet
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 16
Description
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
Time Frame
Baseline and Week 16
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at Week 16
Description
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). The percent change from Baseline was calculated from a rolling weekly average; a negative change from Baseline indicates improvement.
Time Frame
Baseline (Week 0) to Week 16
Title
Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16
Description
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
Time Frame
Baseline and Week 16
Title
Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16
Description
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
Time Frame
Baseline and Week 16
Title
Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at Week 4
Description
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). The percent change from Baseline was calculated from a rolling weekly average; a negative change from Baseline indicates improvement.
Time Frame
Baseline (Week 0) to Week 4
Title
Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score at Week 2
Description
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
Time Frame
Baseline and Week 2
Title
Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at Week 1
Description
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). The percent change from Baseline was calculated from a rolling weekly average; a negative change from Baseline indicates improvement.
Time Frame
Baseline (Week 0) to Week 1
Title
Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 16
Description
The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
Time Frame
Baseline and Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant has active moderate to severe atopic dermatitis (AD) defined by Eczema Area and Severity Index (EASI) ≥ 16, Investigator's Global Assessment (IGA) ≥ 3, ≥ 10% body surface area (BSA) of AD involvement at the Screening and Baseline Visits, and Baseline weekly average of daily Worst Pruritus NRS ≥ 4. Participant is a candidate for systemic therapy or have recently required systemic therapy for AD. Exclusion Criteria: Participant has prior exposure to Janus Kinase (JAK) inhibitor. Participant has prior exposure to dupilumab. Participant is unable or unwilling to discontinue current AD treatments prior to the study. Participant has requirement of prohibited medications during the study. Participant has other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of AD lesions. Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Center AL /ID# 210277
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209-6802
Country
United States
Facility Name
University of Arkansas for Medical Sciences /ID# 211688
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Tien Q Nguyen MD, Inc /ID# 208934
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708-3701
Country
United States
Facility Name
UCSF Fresno /ID# 213253
City
Fresno
State/Province
California
ZIP/Postal Code
93701-2302
Country
United States
Facility Name
Jonathan Corren, MD. INC /ID# 208987
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025-4749
Country
United States
Facility Name
California Allergy and Asthma Medical Group /ID# 213680
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025-7014
Country
United States
Facility Name
Dermatology Research Associates /ID# 209097
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Los Angelos Cataract Center /ID# 208524
City
Los Angeles
State/Province
California
ZIP/Postal Code
90056
Country
United States
Facility Name
Dermatology Clinical Trials /ID# 214622
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660-7853
Country
United States
Facility Name
UC Davis Health /ID# 209285
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Ucsd /Id# 208990
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Clinical Science Institute /ID# 211022
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404-2102
Country
United States
Facility Name
The Community Research of South Florida /ID# 211145
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016-1897
Country
United States
Facility Name
Miami Dermatology and Laser Institute /ID# 212938
City
Miami
State/Province
Florida
ZIP/Postal Code
33173-3570
Country
United States
Facility Name
Florida International Rsrch cr /ID# 211562
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Progressive Medical Research /ID# 211994
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
GCP Research /ID# 216020
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Clinical Research Trials of Florida, Inc. /ID# 210751
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Integrated Clinical Research LLC /ID# 208831
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33406-6063
Country
United States
Facility Name
Georgia Pollens Clinical Research Centers, Inc /ID# 211092
City
Albany
State/Province
Georgia
ZIP/Postal Code
31707-1282
Country
United States
Facility Name
Meridian Clinical Research Dermatology /ID# 213251
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406-2632
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine /ID# 208680
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2927
Country
United States
Facility Name
Medical Dermatology Associates of Chicago /ID# 210265
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654-6903
Country
United States
Facility Name
Sneeze, Wheeze, & Itch Associates, LLC /ID# 212058
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Dawes Fretzin, LLC /ID# 209187
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Beacon Clinical Research, LLC /ID# 209280
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
Clarkston Skin Research /ID# 208739
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Henry Ford Health System /ID# 208741
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Clinical Research Institute, Inc /ID# 210852
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402-2606
Country
United States
Facility Name
Allergy, Asthma & Immunology Associates, PC /ID# 213481
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68505-2343
Country
United States
Facility Name
Skin Specialists, PC /ID# 208843
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center /ID# 213727
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Montefiore Medical Center /ID# 209647
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Forest Hills Dermatology Group /ID# 209249
City
Kew Gardens
State/Province
New York
ZIP/Postal Code
11415
Country
United States
Facility Name
Wake Forest Univ HS /ID# 208892
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Univ Hosp Cleveland /ID# 208852
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Ohio State University /ID# 209254
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1257
Country
United States
Facility Name
Southside Dermatology /ID# 212004
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74132
Country
United States
Facility Name
Oregon Medical Res Center PC /ID# 208807
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Oregon Health and Science University /ID# 208809
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Medical University of South Carolina /ID# 211054
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Clinical Research Solutions, LLC /ID# 212542
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305-2163
Country
United States
Facility Name
Orion Clinical Research /ID# 208765
City
Austin
State/Province
Texas
ZIP/Postal Code
78759-4100
Country
United States
Facility Name
DiscoveResearch, Inc. /ID# 213171
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Epiphany Dermatology - Fort Worth /ID# 211187
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76244-6548
Country
United States
Facility Name
Sante Clinical Research /ID# 212970
City
Kerrville
State/Province
Texas
ZIP/Postal Code
78028-9640
Country
United States
Facility Name
Stephen Miller, MD PA /ID# 210071
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Sugar Land Allergy, Asthma, and Immunology Center /ID# 211153
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479-3153
Country
United States
Facility Name
University of Utah /ID# 209001
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5500
Country
United States
Facility Name
Clinical Research Partners, LLC /ID# 212262
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23220-4459
Country
United States
Facility Name
Premier Clinical Research /ID# 212142
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
West Virginia Research Inst /ID# 212730
City
South Charleston
State/Province
West Virginia
ZIP/Postal Code
25309
Country
United States
Facility Name
Holdsworth House Medical Practice /ID# 214565
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
The Skin Hospital /ID# 214401
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Veracity Clinical Research /ID# 211134
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Sinclair Dermatology /ID# 209395
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Burswood Dermatology /ID# 214875
City
Victoria Park
State/Province
Western Australia
ZIP/Postal Code
6100
Country
Australia
Facility Name
Kirk Barber Research, CA /ID# 209504
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2G 1B1
Country
Canada
Facility Name
Dermatology Research Institute Inc. /ID# 210942
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7E1
Country
Canada
Facility Name
Dr. Chih-ho Hong Medical Inc. /ID# 211032
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Enverus Medical Research /ID# 209503
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Facility Name
Dr. Wei Jing Loo Medicine Prof /ID# 211400
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Facility Name
Lynderm Research Inc. /ID# 209505
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
DermEdge Research Inc. /ID# 211122
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5H 1G9
Country
Canada
Facility Name
Niakosari Medicine Professional Corporation /ID# 211401
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2M 4J5
Country
Canada
Facility Name
K. Papp Clinical Research /ID# 209509
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Dre Angelique Gagne-Henley M.D. inc. /ID# 209498
City
Saint-Jerome
State/Province
Quebec
ZIP/Postal Code
J7Z 7E2
Country
Canada
Facility Name
DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 209935
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Djecja bolnica Srebrnjak /ID# 209939
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicki bolnicki centar Zagreb /ID# 209976
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 209937
City
Ivanic-Grad
State/Province
Zagrebacka Zupanija
ZIP/Postal Code
10310
Country
Croatia
Facility Name
Fakultni Nemocnice Brno /ID# 212968
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
FN Hradec Kralove /ID# 209116
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Nemocnice Jihlava, prispevkova organizace /ID# 209131
City
Jihlava
ZIP/Postal Code
586 01
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava /ID# 209117
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Fakultni Nemocnice v Motole /ID# 209209
City
Praha
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Keski-pohjanmaa Central Hospital /ID# 209534
City
Kokkola
State/Province
Keski-Pohjanmaa
ZIP/Postal Code
67200
Country
Finland
Facility Name
Oulu University Hospital /ID# 208961
City
Oulu
State/Province
Pohjois-Pohjanmaa
ZIP/Postal Code
90220
Country
Finland
Facility Name
Mikkeli Central Hospital /ID# 210125
City
Mikkeli
ZIP/Postal Code
50100
Country
Finland
Facility Name
Pihlajalinna Turku /ID# 209599
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
CHRU Lille - Hopital Claude Huriez /ID# 209317
City
Lille CEDEX
State/Province
Hauts-de-France
ZIP/Postal Code
59045
Country
France
Facility Name
CHU de Nantes - Hotel Dieu /ID# 208974
City
Nantes CEDEX 1
State/Province
Pays-de-la-Loire
ZIP/Postal Code
44093
Country
France
Facility Name
Charles Nicolle CHU Rouen /ID# 208973
City
Rouen CEDEX
State/Province
Seine-Maritime
ZIP/Postal Code
76031
Country
France
Facility Name
Hopital de la Timone /ID# 211245
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2 /ID# 213374
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Polyclinique Courlancy /ID# 208975
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Hopital Larrey - CHU de Toulouse /ID# 208976
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Universitatsklinikum Munster /ID# 210935
City
Munster
State/Province
Niedersachsen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Gemeinschaftspraxis /ID# 211174
City
Blankenfeld-mahlow
ZIP/Postal Code
15831
Country
Germany
Facility Name
Hautklinik Klinikum Darmstadt /ID# 210938
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Facility Name
Universitaetsklinikum Frankfurt /ID# 210934
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Medizinische Hochschule Hannover /ID# 210939
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
TU Uniklinik Munchen /ID# 210937
City
Munich
ZIP/Postal Code
80802
Country
Germany
Facility Name
Oroshazi Korhaz /ID# 210150
City
Oroshaza
State/Province
Bekes
ZIP/Postal Code
5900
Country
Hungary
Facility Name
Uno Medical Trials Kft /ID# 211177
City
Budapest XIII
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont /ID# 210893
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mor Oktat /ID# 210149
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem Klinikai l.sz. Belgyogyaszati Klinika /ID# 210892
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
St Vincent's University Hosp /ID# 208441
City
Dublin
ZIP/Postal Code
D04 T6F4
Country
Ireland
Facility Name
University Hospital Waterford /ID# 208442
City
Waterford
ZIP/Postal Code
X91 ER8E
Country
Ireland
Facility Name
HaEmek Medical Center /ID# 210153
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Rabin Medical Center /ID# 210012
City
Petakh Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Sheba Medical Center /ID# 210013
City
Ramat Gan
ZIP/Postal Code
5239424
Country
Israel
Facility Name
Ichilov Medical Center /ID# 210014
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 210632
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
IBD Center - IRCCS Istituto Clinico Humanitas /ID# 215726
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
A.O. Policlinico Sant'Orsola Malpighi /ID# 209111
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
A.O.U. di Brescia /ID# 209115
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Ospedale San Giovanni di Dio /ID# 209109
City
Cagliari
ZIP/Postal Code
9124
Country
Italy
Facility Name
AO Univ di Modena /ID# 209110
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Policlinico Univ Tor Vergata /ID# 209112
City
Rome
ZIP/Postal Code
00133
Country
Italy
Facility Name
Hospital Sultan Ismail /ID# 211037
City
Johor Bahru
State/Province
Johor
ZIP/Postal Code
81100
Country
Malaysia
Facility Name
Hospital Pakar Sultanah Fatimah /ID# 210185
City
Muar
State/Province
Johor
ZIP/Postal Code
84000
Country
Malaysia
Facility Name
UKM Medical Centre /ID# 209178
City
Kuala Lumpur
State/Province
Selangor
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
University Malaya Med Ctr /ID# 208861
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Hospital Pulau Pinang /ID# 210212
City
Penang
ZIP/Postal Code
10450
Country
Malaysia
Facility Name
Hospital Putrajaya /ID# 209177
City
Putrajaya
ZIP/Postal Code
62250
Country
Malaysia
Facility Name
Bravis Ziekenhuis /ID# 208584
City
Bergen op Zoom
State/Province
Noord-Brabant
ZIP/Postal Code
4624 VT
Country
Netherlands
Facility Name
Academisch Medisch Centrum /ID# 208578
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Centrum Oosterwal /ID# 209641
City
Alkmaar
ZIP/Postal Code
1817 MS
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen /ID# 208583
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Erasmus Medisch Centrum /ID# 208582
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht /ID# 208579
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Optimal Clinical Trials Ltd /ID# 209475
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
Clinical Trials NZ /ID# 215590
City
Hamilton
ZIP/Postal Code
3206
Country
New Zealand
Facility Name
Wellington Hospital (Capital and Coast District Health Board) /ID# 215001
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
St. Olavs Hospital HF /ID# 209137
City
Trondheim
State/Province
Sor-Trondelag
ZIP/Postal Code
7006
Country
Norway
Facility Name
Universitetssykehuset N-Norge, Harstad /ID# 209105
City
Harstad
State/Province
Troms
ZIP/Postal Code
9406
Country
Norway
Facility Name
Universitetssykehuset N-Norge, Tromso /ID# 209103
City
Tromso
State/Province
Troms
ZIP/Postal Code
9019
Country
Norway
Facility Name
Szpital Uniwersytecki nr 1 im. dr. A. Jurasza w Bydgoszczy /ID# 211103
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-094
Country
Poland
Facility Name
Dermoklinika Medical Center /ID# 211026
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-436
Country
Poland
Facility Name
Pratia MCM Krakow /ID# 207444
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Klinika Ambroziak Sp. z o.o. /ID# 207443
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-758
Country
Poland
Facility Name
Royalderm Agnieszka Nawrocka /ID# 211015
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-962
Country
Poland
Facility Name
ClinicMed Daniluk, Nowak Sp.j. /ID# 211112
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-879
Country
Poland
Facility Name
National Skin Centre /ID# 208775
City
Singapore
State/Province
Central Singapore
ZIP/Postal Code
308205
Country
Singapore
Facility Name
National University Hospital /ID# 208774
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Singapore General Hospital /ID# 208776
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Hospital Universitario de Bellvitge /ID# 207063
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario Dr. Negrin /ID# 208969
City
Las Palmas de Gran Canaria
State/Province
Las Palmas
ZIP/Postal Code
35010
Country
Spain
Facility Name
Hospital de Manises /ID# 207062
City
Manises
State/Province
Valencia
ZIP/Postal Code
46940
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Pontevedra /ID# 207139
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Facility Name
Hospital Universitario Arnau Vilanova /ID# 207065
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe /ID# 207064
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Skanes Universitetssjukhus /ID# 206783
City
Malmö
State/Province
Skane Lan
ZIP/Postal Code
214 28
Country
Sweden
Facility Name
Karolinska University Hospital /ID# 207909
City
Stockholm
ZIP/Postal Code
SE-17176
Country
Sweden
Facility Name
China Medical University Hosp /ID# 209770
City
Taichung City
State/Province
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Taiwan University Hospital /ID# 208309
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Chung Shan Medical University /ID# 208311
City
Taichung City
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
Taipei Municipal Wan Fang Hospital /ID# 209987
City
Taipei
ZIP/Postal Code
116
Country
Taiwan
Facility Name
Military Hospital of Military-Medical Clinical Center of Southern Region /ID# 210435
City
Zaporizhzhya
State/Province
Zaporizka Oblast
ZIP/Postal Code
69063
Country
Ukraine
Facility Name
Kyiv City Clinical Skin and Venereal Hospital /ID# 210755
City
Kyiv
ZIP/Postal Code
04209
Country
Ukraine
Facility Name
ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 210434
City
Rivne
ZIP/Postal Code
33028
Country
Ukraine
Facility Name
Royal Alex Childrens County Hospital /ID# 209709
City
Brighton
State/Province
Brighton And Hove
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Victoria Hospital /ID# 209853
City
Kirkcaldy
State/Province
Fife
ZIP/Postal Code
KY2 5AH
Country
United Kingdom
Facility Name
Royal Hospital for Children /ID# 210451
City
Glasgow
State/Province
Glasgow City
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
The Royal Free Hospital /ID# 208659
City
London
State/Province
London, City Of
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Guy's and St Thomas' NHS Found /ID# 208881
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Cardiff & Vale University Health Board /ID# 209745
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing, please refer to the link below.
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Citations:
PubMed Identifier
34347860
Citation
Blauvelt A, Teixeira HD, Simpson EL, Costanzo A, De Bruin-Weller M, Barbarot S, Prajapati VH, Lio P, Hu X, Wu T, Liu J, Ladizinski B, Chu AD, Eyerich K. Efficacy and Safety of Upadacitinib vs Dupilumab in Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2021 Sep 1;157(9):1047-1055. doi: 10.1001/jamadermatol.2021.3023. Erratum In: JAMA Dermatol. 2022 Feb 1;158(2):219. JAMA Dermatol. 2022 Feb 1;158(2):219.
Results Reference
result
Links:
URL
https://www.rxabbvie.com/
Description
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Learn more about this trial

A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis

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