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A Study to Assess Treat-to-Target and Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic Dermatitis (Flex-Up)

Primary Purpose

Atopic Dermatitis

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
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 Atopic Dermatitis (AD), Upadacitinib, RINVOQ

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic AD with onset of symptoms at least 3 years prior to Baseline and participant meets Hanifin and Rajka criteria.
  • EASI score >= 16, vIGA-AD score >= 3 and >= 10% Body Surface Area (BSA) of AD involvement at the Baseline Visit.
  • Baseline weekly average of daily Worst Pruritus NRS >= 4.
  • Candidate for systemic treatment defined as prior use of systemic treatment for AD, OR previous inadequate response to TCS, TCI or PDE-4 inhibitors, OR for whom topical treatments are otherwise medically inadvisable

Exclusion Criteria:

  • Participants with current or past history of infection including:

    • Two or more episodes of herpes zoster, or one or more episodes of disseminated herpes zoster;
    • One or more episodes of disseminated herpes simplex (including eczema herpeticum);
    • Human immunodeficiency virus (HIV) infection defined as confirmed positive anti-HIV antibody (HIV Ab) test;
    • Active tuberculosis (TB) or meet TB exclusionary parameters (protocol specified requirements for TB testing);
    • Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to the Baseline Visit;
    • Chronic recurring infection and/or active viral infection that, based on the investigator's clinical assessment, makes the participant an unsuitable candidate for the study;
    • Confirmed COVID-19: the Baseline visit must be at least 14 days from onset of signs/symptoms or positive SARS-CoV-2 test; symptomatic participants must have recovered, defined as resolution of fever without use of antipyretics and improvement in symptoms; or
    • Suspected COVID-19: participants with signs/symptoms suggestive of COVID-19, known exposure, or high-risk behavior should undergo molecular (e.g., Polymerase chain reaction [PCR]) testing to rule out SARS-CoV-2 infection or must be asymptomatic for 14 days from a potential exposure.
  • Participants must not have evidence of Hepatitis B virus (HBV) or Hepatitis C virus (HCV).

  • Participant must not have any of the following medical diseases or disorders:

    • Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, and aorto-coronary bypass surgery;
    • History of an organ transplant which requires continued immunosuppression;
    • Participant must not have a history of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class;
    • History of gastrointestinal perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for gastrointestinal perforation per investigator judgment;
    • Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery; participants with a history of gastric banding/segmentation are not excluded;
    • History of malignancy except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix.

Sites / Locations

  • Holdsworth House Medical Practice /ID# 254028Recruiting
  • Premier Specialist /ID# 246150Recruiting
  • Veracity Clinical Research /ID# 246154Recruiting
  • North Eastern Health Specialists /ID# 246153Recruiting
  • Skin Health Institute Inc /ID# 246146Recruiting
  • UCL Saint-Luc /ID# 245842Recruiting
  • Grand Hopital de Charleroi /ID# 245837Recruiting
  • Dermatologie Maldegem /ID# 245840Recruiting
  • CHU de Liege /ID# 245839Recruiting
  • UMHAT Alexandrovska EAD /ID# 246594Recruiting
  • Medical center Cordis /ID# 253310Recruiting
  • Acibadem City Clinic Tokuda University Hospital EAD /ID# 246395Recruiting
  • Ambulatory for Specialized Medical Care for skin and venereal diseases /ID# 247027Recruiting
  • Medical center EuroHealth /ID# 246305Recruiting
  • Medical Center Euroderma /ID# 246736Recruiting
  • Dermatology Research Institute Inc. /ID# 246703Recruiting
  • Beacon Dermatology Inc /ID# 246705Recruiting
  • Alberta DermaSurgery Centre /ID# 247286Recruiting
  • Dr. Chih-ho Hong Medical Inc. /ID# 246700Recruiting
  • Lynderm Research Inc. /ID# 246699Recruiting
  • SKIN Centre for Dermatology /ID# 246702Recruiting
  • Alliance Clinical Trials /ID# 246698Recruiting
  • Universitaetsklinikum Frankfurt /ID# 245627Recruiting
  • Universitaetsklinikum Muenster /ID# 245623Recruiting
  • Fachklinik Bad Bentheim /ID# 245634Recruiting
  • Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 245636Recruiting
  • Elbe Klinikum Buxtehude /ID# 245626Recruiting
  • Klinikum Darmstadt /ID# 247028Recruiting
  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 248413Recruiting
  • Derma Study Center Friedrichshafen GmbH /ID# 245640Recruiting
  • Universitaetsklinikum Halle (Saale) /ID# 245637Recruiting
  • Dermatologikum Hamburg GmbH /ID# 245635Recruiting
  • Dermatologische Gemeinschaftspraxis Mahlow /ID# 245629Recruiting
  • Dermatologie Quist-BAG Dres. med. Quist PartG /ID# 245628Recruiting
  • Gyongyosi Bugat Pal Korhaz /ID# 246422Recruiting
  • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 246428Recruiting
  • Clinexpert Kft /ID# 246427Recruiting
  • Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 246426Recruiting
  • Istituto Clinico Humanitas /ID# 246630Recruiting
  • Azienda Ospedaliera di Perugia /ID# 246632Recruiting
  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 254355Recruiting
  • ASST Spedali civili di Brescia /ID# 246631Recruiting
  • Universita degli Studi Gabriele dAnnunzio /ID# 246629Recruiting
  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 246634Recruiting
  • Miyata Dermatology Clinic /ID# 255491Recruiting
  • Fukuoka University Hospital /ID# 255182Recruiting
  • Takagi Dermatological Clinic Branch /ID# 255181Recruiting
  • Nomura Dermatology Clinic /ID# 255534Recruiting
  • Tohoku University Hospital /ID# 255183Recruiting
  • Maruyama Dermatology Clinic /ID# 255441Recruiting
  • Korea University Ansan Hospital /ID# 245653Recruiting
  • Soonchunhyang University Hospital Bucheon /ID# 245654Recruiting
  • Ajou University Hospital /ID# 245652Recruiting
  • KonKuk University Medical Center /ID# 245657Recruiting
  • Seoul National University Hospital /ID# 245651Recruiting
  • Chung-Ang University Hostipal /ID# 245655Recruiting
  • Academisch Medisch Centrum /ID# 245673Recruiting
  • Amphia Ziekenhuis /ID# 246397Recruiting
  • Greenlane Clinical Centre /ID# 246556Recruiting
  • Middlemore Hospital /ID# 246559Recruiting
  • Clinical Trials NZ /ID# 246557Recruiting
  • MICS Centrum Medyczne Torun /ID# 245749Recruiting
  • Dermed Centrum Medyczne Sp. z o.o /ID# 246329Recruiting
  • Santa Sp. z o.o. Santa Familia Centrum Badan, Profilaktyki i Leczenia /ID# 253872Recruiting
  • Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 245836Recruiting
  • CenterMed Krakow Sp. z o.o. /ID# 253940Recruiting
  • Klinika Ambroziak Sp. z o.o. /ID# 245748Recruiting
  • Royalderm Agnieszka Nawrocka /ID# 245746Recruiting
  • Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 245741Recruiting
  • Centrum Medyczne Pratia Gdynia /ID# 245835Recruiting
  • Silmedic Sp. z o.o. /ID# 253863Recruiting
  • Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z o.o. /ID# 253846Recruiting
  • Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus /ID# 253508Recruiting
  • OFTALMIKA Sp. z o.o. /ID# 253429Recruiting
  • Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 246247Recruiting
  • Hospital CUF Descobertas /ID# 245702Recruiting
  • Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 245701Recruiting
  • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 245704Recruiting
  • Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 247515Recruiting
  • BeneDerma s.r.o. /ID# 247513Recruiting
  • Univerzitna nemocnica Martin /ID# 246948Recruiting
  • Hospital Universitario de Bellvitge /ID# 246326Recruiting
  • Hospital Universitario Puerta de Hierro, Majadahonda /ID# 253820Recruiting
  • Hospital General Universitario de Alicante Doctor Balmis /ID# 246270Recruiting
  • Hospital Universitario Infanta Leonor /ID# 246272Recruiting
  • Hospital Universitario Ramon y Cajal /ID# 246273Recruiting
  • Complejo Hospitalario Universitario de Pontevedra /ID# 246323Recruiting
  • Hospital Universitario Virgen del Rocio /ID# 253822Recruiting
  • Chung Shan Medical University Hospital /ID# 245707Recruiting
  • National Taiwan University Hospital /ID# 245711Recruiting
  • MacKay Memorial Hospital /ID# 245713Recruiting
  • Taipei Municipal Wan Fang Hospital /ID# 245712Recruiting
  • Linkou Chang Gung Memorial Hospital /ID# 245709Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Double-Blind Treatment Period Dose A

Double-Blind Treatment Period Dose B

Single-Blinded Treatment Period Arm A

Single-Blinded Treatment Period Arm B

Single-Blinded Treatment Period Arm C

Single-Blinded Treatment Period Arm D

Arm Description

Participants will be administered updadacitinib Dose A once daily (QD) for 12 weeks.

Participants will be administered updadacitinib Dose B once daily (QD) for 12 weeks.

Participants will be administered updadacitinib once daily (QD) for 12 weeks.

Participants will be administered updadacitinib once daily (QD) for 12 weeks.

Participants will be administered updadacitinib once daily (QD) for 12 weeks.

Participants will be administered updadacitinib once daily (QD) for 12 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 90
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

Percentage of Participants Achieving EASI 75
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 EASI 100
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 EASI 75
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 EASI 90
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 EASI 100
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 EASI 90 and Worst Pruritus Numerical Rating Scale (NRS) of 0 or 1
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 final EASI score ranges from 0 to 72 where higher scores represent worse disease. Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, with '0' being 'no itch' and '10' being 'worst imaginable itch', over the previous 24 hours.
Percentage of Participants Achieving EASI 90 and Worst Pruritus NRS of 0 or 1
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 final EASI score ranges from 0 to 72 where higher scores represent worse disease. Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, with '0' being 'no itch' and '10' being 'worst imaginable itch', over the previous 24 hours.
Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1
vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.
Percentage of Participants Achieving Improvement (reduction) in Worst Pruritus NRS of >= 4
Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, with '0' being 'no itch' and '10' being 'worst imaginable itch', over the previous 24 hours. Higher score denoting worse itch.
Percentage of Participants Achieving Worst Pruritus NRS of 0 or 1
Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, with '0' being 'no itch' and '10' being 'worst imaginable itch', over the previous 24 hours. Higher score denoting worse itch.
Percentage of Participants Achieving Improvement (reduction) in Dermatology Life Quality Index (DLQI) of >= 4
DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of participant's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL.
Percentage of Participants Achieving DLQI of 0 or 1
DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of participant's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL.

Full Information

First Posted
August 18, 2022
Last Updated
October 23, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT05507580
Brief Title
A Study to Assess Treat-to-Target and Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic Dermatitis
Acronym
Flex-Up
Official Title
A Phase 3b/4 Randomized, Blinded, Treat-to-Target and Dose-Flexibility Study of Upadacitinib in Adult Subjects With Moderate to Severe Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2023 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
March 2, 2025 (Anticipated)

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
No

5. Study Description

Brief Summary
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study evaluates the dosing flexibility of upadacitinib in adult participants with moderate to severe AD. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for the treatment of moderate to severe/active immune-mediated inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and AD. The study is comprised of a 35-day Screening Period, a 12-week double-blind period and a 12-week single-blind period. During the double-blind period, participants are placed in 1 of 2 groups, called treatment arms and will be randomized in a 1:1 ratio to receive upadacitinib. At 12 weeks during the single blind period, participants will be blinded to the upadacitinib dose based on their EASI response and reassigned to in 1 of 4 arms. After the last study visit, there is a 30-day follow-up visit. Approximately 454 adult participants ages 18 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 160 sites worldwide. The study is comprised of a 12-week double-blind period, followed by a 12-week single-blind period. Participants will receive upadacitinib oral tablets once daily for up to 24 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic Dermatitis (AD), Upadacitinib, RINVOQ

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
454 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Double-Blind Treatment Period Dose A
Arm Type
Experimental
Arm Description
Participants will be administered updadacitinib Dose A once daily (QD) for 12 weeks.
Arm Title
Double-Blind Treatment Period Dose B
Arm Type
Experimental
Arm Description
Participants will be administered updadacitinib Dose B once daily (QD) for 12 weeks.
Arm Title
Single-Blinded Treatment Period Arm A
Arm Type
Experimental
Arm Description
Participants will be administered updadacitinib once daily (QD) for 12 weeks.
Arm Title
Single-Blinded Treatment Period Arm B
Arm Type
Experimental
Arm Description
Participants will be administered updadacitinib once daily (QD) for 12 weeks.
Arm Title
Single-Blinded Treatment Period Arm C
Arm Type
Experimental
Arm Description
Participants will be administered updadacitinib once daily (QD) for 12 weeks.
Arm Title
Single-Blinded Treatment Period Arm D
Arm Type
Experimental
Arm Description
Participants will be administered updadacitinib once daily (QD) for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
RINVOQ, ABT-494
Intervention Description
Oral tablet
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 90
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
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving EASI 75
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
Week 24
Title
Percentage of Participants Achieving EASI 100
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
Up to Week 24
Title
Percentage of Participants Achieving EASI 75
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
Week 12
Title
Percentage of Participants Achieving EASI 90
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
Week 12
Title
Percentage of Participants Achieving EASI 100
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
Week 12
Title
Percentage of Participants Achieving EASI 90 and Worst Pruritus Numerical Rating Scale (NRS) of 0 or 1
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 final EASI score ranges from 0 to 72 where higher scores represent worse disease. Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, with '0' being 'no itch' and '10' being 'worst imaginable itch', over the previous 24 hours.
Time Frame
Week 12
Title
Percentage of Participants Achieving EASI 90 and Worst Pruritus NRS of 0 or 1
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 final EASI score ranges from 0 to 72 where higher scores represent worse disease. Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, with '0' being 'no itch' and '10' being 'worst imaginable itch', over the previous 24 hours.
Time Frame
Week 24
Title
Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1
Description
vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.
Time Frame
Up to Week 24
Title
Percentage of Participants Achieving Improvement (reduction) in Worst Pruritus NRS of >= 4
Description
Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, with '0' being 'no itch' and '10' being 'worst imaginable itch', over the previous 24 hours. Higher score denoting worse itch.
Time Frame
Up to Week 24
Title
Percentage of Participants Achieving Worst Pruritus NRS of 0 or 1
Description
Worst Pruritus NRS is a validated single self-reported item designed to measure peak pruritus, with '0' being 'no itch' and '10' being 'worst imaginable itch', over the previous 24 hours. Higher score denoting worse itch.
Time Frame
Up to Week 24
Title
Percentage of Participants Achieving Improvement (reduction) in Dermatology Life Quality Index (DLQI) of >= 4
Description
DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of participant's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL.
Time Frame
Up to Week 24
Title
Percentage of Participants Achieving DLQI of 0 or 1
Description
DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on health-related quality of life (HRQoL). It consists of 10 questions assessing impact of skin diseases on different aspects of participant's QoL over the prior week. Each item is scored on a 4-point scale: 0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30. Higher scores indicate greater impairment of HRQoL.
Time Frame
Up to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline and participant meets Hanifin and Rajka criteria. Eczema Area and Severity Index (EASI) score >= 16, vIGA-AD score >= 3 and >= 10% Body Surface Area (BSA) of AD involvement at the Baseline Visit. Baseline weekly average of daily Worst Pruritus NRS >= 4. Candidate for systemic treatment defined as prior use of systemic treatment for AD, OR previous inadequate response to TCS, TCI or PDE-4 inhibitors, OR for whom topical treatments are otherwise medically inadvisable. Exclusion Criteria: Participants with current or past history of infection including: Two or more episodes of herpes zoster, or one or more episodes of disseminated herpes zoster; One or more episodes of disseminated herpes simplex (including eczema herpeticum); Human immunodeficiency virus (HIV) infection defined as confirmed positive anti-HIV antibody (HIV Ab) test; Active tuberculosis (TB) or meet TB exclusionary parameters (protocol specified requirements for TB testing); Japan only: Positive result of beta-D-glucan (screening for Pneumocystis jirovecii infection) or two consecutive indeterminate results of beta-D-glucan during the Screening Period; Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to the Baseline Visit; Chronic recurring infection and/or active viral infection that, based on the investigator's clinical assessment, makes the participant an unsuitable candidate for the study; COVID-19 infection: In participants who tested positive for COVID, at least 5 days must have passed since a COVID-19 positive test result for study entry of asymptomatic participants. Participants with mild/moderate COVID-19 infection can be enrolled if fever is resolved without use of antipyretics for 24 hours and other symptoms improved, or if 5 days have passed since the COVID-19 positive test result (whichever comes last). Participants may be rescreened if judged to be in good general health, as determined by the investigator based upon the medical history and physical examination. Evidence of Hepatitis B virus (HBV) or Hepatitis C virus (HCV). Any of the following medical diseases or disorders: Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, and aorto-coronary bypass surgery; History of an organ transplant which requires continued immunosuppression; History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class; History of gastrointestinal perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for gastrointestinal perforation per investigator judgment; Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery; participants with a history of gastric banding/segmentation are not excluded; History of malignancy except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Holdsworth House Medical Practice /ID# 254028
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Name
Premier Specialist /ID# 246150
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Recruiting
Facility Name
Veracity Clinical Research /ID# 246154
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Name
North Eastern Health Specialists /ID# 246153
City
Campbelltown
State/Province
South Australia
ZIP/Postal Code
5074
Country
Australia
Individual Site Status
Recruiting
Facility Name
Skin Health Institute Inc /ID# 246146
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Individual Site Status
Recruiting
Facility Name
UCL Saint-Luc /ID# 245842
City
Woluwe-Saint-Lambert
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Grand Hopital de Charleroi /ID# 245837
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Dermatologie Maldegem /ID# 245840
City
Maldegem
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9990
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU de Liege /ID# 245839
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UMHAT Alexandrovska EAD /ID# 246594
City
Sofiya
State/Province
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical center Cordis /ID# 253310
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Acibadem City Clinic Tokuda University Hospital EAD /ID# 246395
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Ambulatory for Specialized Medical Care for skin and venereal diseases /ID# 247027
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical center EuroHealth /ID# 246305
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Euroderma /ID# 246736
City
Sofiya
ZIP/Postal Code
1606
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Dermatology Research Institute Inc. /ID# 246703
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7E1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Beacon Dermatology Inc /ID# 246705
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3E 0B2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Alberta DermaSurgery Centre /ID# 247286
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Dr. Chih-ho Hong Medical Inc. /ID# 246700
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Lynderm Research Inc. /ID# 246699
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Individual Site Status
Recruiting
Facility Name
SKIN Centre for Dermatology /ID# 246702
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Alliance Clinical Trials /ID# 246698
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Frankfurt /ID# 245627
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Muenster /ID# 245623
City
Muenster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Fachklinik Bad Bentheim /ID# 245634
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Individual Site Status
Recruiting
Facility Name
Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 245636
City
Bramsche
ZIP/Postal Code
49565
Country
Germany
Individual Site Status
Recruiting
Facility Name
Elbe Klinikum Buxtehude /ID# 245626
City
Buxtehude
ZIP/Postal Code
21614
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Darmstadt /ID# 247028
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 248413
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Derma Study Center Friedrichshafen GmbH /ID# 245640
City
Friedrichshafen
ZIP/Postal Code
88045
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Halle (Saale) /ID# 245637
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Dermatologikum Hamburg GmbH /ID# 245635
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Individual Site Status
Recruiting
Facility Name
Dermatologische Gemeinschaftspraxis Mahlow /ID# 245629
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Individual Site Status
Recruiting
Facility Name
Dermatologie Quist-BAG Dres. med. Quist PartG /ID# 245628
City
Mainz
ZIP/Postal Code
55128
Country
Germany
Individual Site Status
Recruiting
Facility Name
Gyongyosi Bugat Pal Korhaz /ID# 246422
City
Gyongyos
State/Province
Heves
ZIP/Postal Code
3200
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 246428
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Clinexpert Kft /ID# 246427
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 246426
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Istituto Clinico Humanitas /ID# 246630
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera di Perugia /ID# 246632
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06129
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 254355
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Spedali civili di Brescia /ID# 246631
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Universita degli Studi Gabriele dAnnunzio /ID# 246629
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 246634
City
Milan
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Miyata Dermatology Clinic /ID# 255491
City
Matsudo-Shi
State/Province
Chiba
ZIP/Postal Code
271-0092
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukuoka University Hospital /ID# 255182
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Individual Site Status
Recruiting
Facility Name
Takagi Dermatological Clinic Branch /ID# 255181
City
Obihiro-shi
State/Province
Hokkaido
ZIP/Postal Code
080-0013
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nomura Dermatology Clinic /ID# 255534
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
221-0825
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tohoku University Hospital /ID# 255183
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Individual Site Status
Recruiting
Facility Name
Maruyama Dermatology Clinic /ID# 255441
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
136-0074
Country
Japan
Individual Site Status
Recruiting
Facility Name
Korea University Ansan Hospital /ID# 245653
City
Ansan
State/Province
Gyeonggido
ZIP/Postal Code
15355
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Soonchunhyang University Hospital Bucheon /ID# 245654
City
Bucheon
State/Province
Gyeonggido
ZIP/Postal Code
14584
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ajou University Hospital /ID# 245652
City
Suwon
State/Province
Gyeonggido
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
KonKuk University Medical Center /ID# 245657
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
05030
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital /ID# 245651
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chung-Ang University Hostipal /ID# 245655
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Academisch Medisch Centrum /ID# 245673
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Amphia Ziekenhuis /ID# 246397
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Greenlane Clinical Centre /ID# 246556
City
Epsom
State/Province
Auckland
ZIP/Postal Code
1051
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Middlemore Hospital /ID# 246559
City
Otahuhu
State/Province
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Clinical Trials NZ /ID# 246557
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
MICS Centrum Medyczne Torun /ID# 245749
City
Torun
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
87-100
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
+48 56 300 43 00
Facility Name
Dermed Centrum Medyczne Sp. z o.o /ID# 246329
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-265
Country
Poland
Individual Site Status
Recruiting
Facility Name
Santa Sp. z o.o. Santa Familia Centrum Badan, Profilaktyki i Leczenia /ID# 253872
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-302
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 245836
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-011
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
+48 791 463 018
Facility Name
CenterMed Krakow Sp. z o.o. /ID# 253940
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-530
Country
Poland
Individual Site Status
Recruiting
Facility Name
Klinika Ambroziak Sp. z o.o. /ID# 245748
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-953
Country
Poland
Individual Site Status
Recruiting
Facility Name
Royalderm Agnieszka Nawrocka /ID# 245746
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-962
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
+48508 575 509
Facility Name
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 245741
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-546
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
+48587192223
Facility Name
Centrum Medyczne Pratia Gdynia /ID# 245835
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-338
Country
Poland
Individual Site Status
Recruiting
Facility Name
Silmedic Sp. z o.o. /ID# 253863
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-282
Country
Poland
Individual Site Status
Recruiting
Facility Name
Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z o.o. /ID# 253846
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
61-578
Country
Poland
Individual Site Status
Recruiting
Facility Name
Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus /ID# 253508
City
Poznań
State/Province
Wielkopolskie
ZIP/Postal Code
60-693
Country
Poland
Individual Site Status
Recruiting
Facility Name
OFTALMIKA Sp. z o.o. /ID# 253429
City
Bydgoszcz
ZIP/Postal Code
85-631
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 246247
City
Lisboa
ZIP/Postal Code
1169-050
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital CUF Descobertas /ID# 245702
City
Lisboa
ZIP/Postal Code
1998-018
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 245701
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 245704
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 247515
City
Bratislava
ZIP/Postal Code
811 09
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
BeneDerma s.r.o. /ID# 247513
City
Bratislava
ZIP/Postal Code
841 04
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Univerzitna nemocnica Martin /ID# 246948
City
Martin
ZIP/Postal Code
036 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Bellvitge /ID# 246326
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Puerta de Hierro, Majadahonda /ID# 253820
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario de Alicante Doctor Balmis /ID# 246270
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Infanta Leonor /ID# 246272
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramon y Cajal /ID# 246273
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario Universitario de Pontevedra /ID# 246323
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocio /ID# 253822
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Chung Shan Medical University Hospital /ID# 245707
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital /ID# 245711
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
MacKay Memorial Hospital /ID# 245713
City
Taipei City
ZIP/Postal Code
10449
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Municipal Wan Fang Hospital /ID# 245712
City
Taipei
ZIP/Postal Code
116
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Linkou Chang Gung Memorial Hospital /ID# 245709
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting

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, analyses plans, 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 visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.rxabbvie.com/
Description
Related Info

Learn more about this trial

A Study to Assess Treat-to-Target and Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic Dermatitis

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