Atopic DermatitisPhase 4Flex-UpNCT05507580
A Study to Assess Treat-to-Target and Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic Dermatitis
A Phase 4 study testing Upadacitinib in people with Atopic Dermatitis, run by AbbVie at 106 sites in 18 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Upadacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 461 participants
- Where
- 106 sitesin 18 countries
- Study dates
- 29 May 2023to 15 Aug 2024
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
106 sites in 18 countries.
106 sites in 18 countries
Poland13 sites
Oftalmika sp. z o.o. /ID# 253429
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-631
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 245741
Gdansk, Pomeranian Voivodeship, 80-546
Centrum Medyczne Pratia Gdynia /ID# 245835
Gdynia, Pomeranian Voivodeship, 81-338
Silmedic Sp. z o.o. /ID# 253863
Katowice, Silesian Voivodeship, 40-282
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 245836
Krakow, Lesser Poland Voivodeship, 31-011
CenterMed Krakow Sp. z o.o. /ID# 253940
Krakow, Lesser Poland Voivodeship, 31-530
Dermed Centrum Medyczne Sp. z o.o /ID# 246329
Lodz, Łódź Voivodeship, 90-265
Santa Sp. z o.o. Santa Familia Centrum Badan, Profilaktyki i Leczenia /ID# 253872
Lodz, Łódź Voivodeship, 90-302
Duplicate_Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus /ID# 253508
Poznan, Greater Poland Voivodeship, 60-693
Specjalistyczna Przychodnia Lekarska Alergo-Med sp. z o.o. /ID# 253846
Poznan, Greater Poland Voivodeship, 61-578
MICS Centrum Medyczne Torun /ID# 245749
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
Klinika Ambroziak Sp. z o.o. /ID# 245748
Warsaw, Masovian Voivodeship, 02-953
Royalderm Agnieszka Nawrocka /ID# 245746
Warsaw, Masovian Voivodeship, 02-962
Germany12 sites
Fachklinik Bad Bentheim /ID# 245634
Bad Bentheim, Lower Saxony, 48455
Dermatologische Gemeinschaftspraxis Mahlow /ID# 245629
Blankenfelde-Mahlow, Brandenburg, 15831
Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 245636
Bramsche, Lower Saxony, 49565
Elbe Klinikum Buxtehude /ID# 245626
Buxtehude, 21614
Klinikum Darmstadt /ID# 247028
Darmstadt, Hesse, 64283
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 248413
Dresden, Saxony, 01307
Universitaetsklinikum Frankfurt /ID# 245627
Frankfurt am Main, Hesse, 60590
Derma Study Center Friedrichshafen GmbH /ID# 245640
Friedrichshafen, 88045
Universitaetsklinikum Halle (Saale) /ID# 245637
Halle, 06120
Dermatologikum Hamburg /ID# 245635
Hamburg, 20354
Dermatologie Quist-BAG Dres. med. Quist PartG /ID# 245628
Mainz, 55128
Universitaetsklinikum Muenster /ID# 245623
Münster, North Rhine-Westphalia, 48149
Canada8 sites
Dermatology Research Institute - Blackfoot Trail /ID# 246703
Calgary, Alberta, T2J 7E1
Beacon Dermatology Inc /ID# 246705
Calgary, Alberta, T3A 2N1
Rejuvenation Dermatology - Edmonton Downtown /ID# 256790
Edmonton, Alberta, T5J 3S9
Alberta DermaSurgery Centre /ID# 247286
Edmonton, Alberta, T6G 1C3
Lynde Institute for Dermatology /ID# 246699
Markham, Ontario, L3P 1X2
SKiN Centre for Dermatology /ID# 246702
Peterborough, Ontario, K9J 5K2
Dr. Chih-ho Hong Medical Inc. /ID# 246700
Surrey, British Columbia, V3R 6A7
Private Practice - Dr. Kim Papp Clinical Research /ID# 246698
Waterloo, Ontario, N2J 1C4
Spain8 sites
Hospital General Universitario de Alicante Doctor Balmis /ID# 246270
Alicante, 03010
Hospital Universitario Germans Trias i Pujol /ID# 246320
Badalona, Barcelona, 08916
Hospital Universitari de Bellvitge /ID# 246326
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitario Infanta Leonor /ID# 246272
Madrid, 28031
Hospital Universitario Ramon y Cajal /ID# 246273
Madrid, 28034
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 253820
Majadahonda, Madrid, 28222
Complejo Hospitalario Universitario de Pontevedra /ID# 246323
Pontevedra, 36071
Hospital Universitario Virgen del Rocio /ID# 253822
Seville, 41013
Bulgaria6 sites
Medical center Cordis /ID# 253310
Pleven, 5800
Acibadem City Clinic Tokuda University Hospital EAD /ID# 246395
Sofia, 1407
Ambulatory for Specialized Medical Care for skin and venereal diseases /ID# 247027
Sofia, 1407
Medical Center Euroderma /ID# 246736
Sofia, 1606
Medical center EuroHealth /ID# 246305
Sofia, 1606
UMHAT Alexandrovska EAD /ID# 246594
Sofiya, Sofia, 1431
Italy6 sites
Duplicate_Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 254355
Ancona, 60126
Duplicate_ASST Spedali civili di Brescia /ID# 246631
Brescia, 25123
Universita degli Studi Gabriele dAnnunzio /ID# 246629
Chieti, 66100
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 246634
Milan, 20122
Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 246632
Perugia, 06156
IRCCS Istituto Clinico Humanitas /ID# 246630
Rozzano, Lombardy, 20089
Japan6 sites
Fukuoka University Hospital /ID# 255182
Fukuoka, Fukuoka, 814-0180
Maruyama Dermatology Clinic /ID# 255441
Koto-ku, Tokyo, 136-0074
Miyata Dermatology Clinic /ID# 255491
Matsudo-Shi, Chiba, 271-0092
Takagi Dermatological Clinic /ID# 255181
Obihiro-shi, Hokkaido, 080-0013
Tohoku University Hospital /ID# 255183
Sendai, Miyagi, 9808574
Nomura Dermatology Clinic /ID# 255534
Yokohama, Kanagawa, 221-0825
South Korea6 sites
Korea University Ansan Hospital /ID# 245653
Ansan-si, Gyeonggido, 15355
Soon Chun Hyang University Hospital Bucheon /ID# 245654
Bucheon-si, Gyeonggido, 14584
Chungang University Hospital /ID# 245655
Dongjak-gu, Seoul Teugbyeolsi, 06973
Seoul National University Hospital /ID# 245651
Seoul, Seoul Teugbyeolsi, 03080
Konkuk University Medical Center /ID# 245657
Seoul, Seoul Teugbyeolsi, 05030
Ajou University Hospital /ID# 245652
Suwon, Gyeonggido, 16499
Taiwan6 sites
Kaohsiung Chang Gung Memorial Hospital /ID# 245710
Kaohsiung City, Kaohsiung, 833
Chung Shan Medical University Hospital /ID# 245707
Taichung, 40201
Mackay Memorial Hospital /ID# 245713
Taipei, 104
Taipei Municipal Wan Fang Hospital /ID# 245712
Taipei, 116
National Taiwan University Hospital /ID# 245711
Taipei City, Taipei, 100
Linkou Chang Gung Memorial Hospital /ID# 245709
Taoyuan City, 333
Australia5 sites
North Eastern Health Specialists /ID# 246153
Campbelltown, South Australia, 5074
Skin Health Institute Inc /ID# 246146
Carlton, Victoria, 3053
Momentum Clinical Research /ID# 254028
Darlinghurst, New South Wales, 2010
Premier Specialist /ID# 246150
Kogarah, New South Wales, 2217
Veracity Clinical Research /ID# 246154
Woolloongabba, Queensland, 4102
Belgium5 sites
Grand Hôpital De Charleroi - Notre Dame /ID# 245837
Charleroi, Hainaut, 6000
AZ Sint-Lucas /ID# 253708
Ghent, Oost-Vlaanderen, 9000
CHU de Liege /ID# 245839
Liège, 4000
Dermatologie Maldegem /ID# 245840
Maldegem, Oost-Vlaanderen, 9990
Cliniques Universitaires UCL Saint-Luc /ID# 245842
Woluwe-Saint-Lambert, Brussels Capital, 1200
China5 sites
Beijing Friendship Hospital /ID# 247719
Beijing, Beijing Municipality, 100032
Peking University Third Hospital /ID# 247842
Beijing, Beijing Municipality, 100191
Dermatology Hospital of Southern Medical University /ID# 247951
Guangzhou, Guangdong, 510091
Huashan Hospital, Fudan University /ID# 247680
Shanghai, Shanghai Municipality, 200040
The First Hospital of China Medical University /ID# 247686
Shenyang, Liaoning, 110001
Hungary4 sites
Clinexpert Kft /ID# 246427
Budapest, 1033
DERMA-B Egeszsegugyi es Szolgaltato - Debrecen - Gyepusor Utca /ID# 246426
Debrecen, 4031
Gyongyosi Bugat Pal Korhaz /ID# 246422
Gyöngyös, Heves County, 3200
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 246428
Kaposvár, Somogy County, 7400
Portugal4 sites
Centro Hospitalar de Lisboa Central /ID# 246247
Lisbon, 1169-050
Hospital CUF Descobertas /ID# 245702
Lisbon, 1998-018
Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 245701
Porto, 4099-001
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 245704
Porto, 4200-319
United Kingdom4 sites
NHS Lothian /ID# 246245
Edinburgh, EH3 9HE
NHS Greater Glasgow and Clyde /ID# 246253
Glasgow, Scotland, G12 0XH
Leeds Teaching Hospitals NHS Trust /ID# 246241
Leeds, West Yorkshire, LS9 7TF
University Hospital Southampton NHS Foundation Trust /ID# 246393
Southampton, Hampshire, SO16 6YD
New Zealand3 sites
Aotearoa Clinical Trials /ID# 246559
Auckland, 1640
Greenlane Clinical Centre /ID# 246556
Epsom, Auckland, 1051
Clinical Trials New Zealand /ID# 246557
Hamilton, Waikato Region, 3204
Slovakia3 sites
Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 247515
Bratislava, 811 09
BeneDerma s.r.o. /ID# 247513
Bratislava, 841 04
Univerzitna nemocnica Martin /ID# 246948
Martin, Žilina Region, 036 01
Netherlands2 sites
Amsterdam UMC, locatie AMC /ID# 245673
Amsterdam, North Holland, 1105 AZ
Amphia Ziekenhuis /ID# 246397
Breda, North Brabant, 4818 CK
About this study
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
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 (UC), Crohn's Disease (CD), 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.
Read more
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.
- Conditions
- Atopic Dermatitis
- Being tested
- Upadacitinib
- Keywords
- Atopic Dermatitis (AD), Upadacitinib, RINVOQ
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UpadacitinibDrug
Also called RINVOQ, ABT-494
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| UPA 15 mg Double-Blind Treatment Period | Experimental | Participants received 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Double-Blind Treatment Period. Receives: Drug: Upadacitinib |
| UPA 30 mg Double-Blind Treatment Period | Experimental | Participants received 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Double-Blind Treatment Period. Receives: Drug: Upadacitinib |
| UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period | Experimental | At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. Receives: Drug: Upadacitinib |
| UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period | Experimental | At Week 12 in the Double-Blind Treatment Period, participants receiving 15 mg upadacitinib orally once daily (QD) achieving a < 90% reduction in the Eczema Area and Severity Index (EASI) (< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. Receives: Drug: Upadacitinib |
| UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period | Experimental | At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a ≥ 90% reduction in the Eczema Area and Severity Index (EASI) (≥ EASI 90) were allocated to receive 15 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. Receives: Drug: Upadacitinib |
| UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period | Experimental | At Week 12 in the Double-Blind Treatment Period, participants receiving 30 mg upadacitinib orally once daily (QD) achieving a < 90% reduction in the Eczema Area and Severity Index (EASI) (< EASI 90) were allocated to receive 30 mg upadacitinib orally once daily (QD) for 12 weeks during the Single-Blind Treatment Period. Receives: Drug: Upadacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 24
The EASI is a composite index with scores ranging from 0 to 72. Four atopic dermatitis (AD) disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).
Measured: Baseline and Week 24
Secondary outcomes (17)
Percentage of Participants Achieving ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24
The EASI is a composite index with scores ranging from 0 to 72. Four atopic dermatitis (AD) disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).
Measured: Baseline and Week 24
Percentage of Participants Achieving a 100% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 100) at Week 24
The EASI is a composite index with scores ranging from 0 to 72. Four atopic dermatitis (AD) disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).
Measured: Baseline and Week 24
Percentage of Participants Achieving ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 12
The EASI is a composite index with scores ranging from 0 to 72. Four atopic dermatitis (AD) disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).
Measured: Baseline and Week 12
Percentage of Participants Achieving ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 12
The EASI is a composite index with scores ranging from 0 to 72. Four atopic dermatitis (AD) disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).
Measured: Baseline and Week 12
Percentage of Participants Achieving a 100% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 100) at Week 12
The EASI is a composite index with scores ranging from 0 to 72. Four atopic dermatitis (AD) disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) are assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).
Measured: Baseline and Week 12
Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 12 Among Those With WP-NRS > 1 at Baseline
The EASI is a composite index with scores ranging from 0 to 72. Four atopic dermatitis (AD) disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).
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 rated 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).
Measured: Baseline and Week 12
Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 24 Among Those With WP-NRS > 1 at Baseline
The EASI is a composite index with scores ranging from 0 to 72. Four atopic dermatitis (AD) disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%).
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 rated 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).
Measured: Baseline and Week 24
Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1 at Week 12
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).
Measured: At Week 12
Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1 at Week 24
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).
Measured: At Week 24
Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (WP-NRS) ≥4 at Week 12 Among Those With Baseline WP-NRS ≥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 rated 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).
Measured: Baseline and Week 12
Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (WP-NRS) ≥4 at Week 24 Among Those With Baseline WP-NRS ≥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 rated 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).
Measured: Baseline and Week 24
Percentage of Participants Achieving Worst Pruritus Numerical Rating Scale (WP-NRS) of 0 or 1 at Week 12 Among Those With Baseline WP-NRS >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 rated 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).
Measured: Baseline and Week 12
Percentage of Participants Achieving Worst Pruritus Numerical Rating Scale (WP-NRS) of 0 or 1 at Week 24 Among Those With Baseline WP-NRS >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 rated 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).
Measured: Baseline and Week 24
Percentage of Participants Achieving Improvement (Reduction) in Dermatology Life Quality Index (DLQI) ≥4 at Week 12 Among Those With Baseline DLQI ≥4
DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of atopic dermatitis (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.
Measured: Baseline and Week 12
Percentage of Participants Achieving Improvement (Reduction) in Dermatology Life Quality Index (DLQI) ≥4 at Week 24 Among Those With Baseline DLQI ≥4
DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of atopic dermatitis (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.
Measured: Baseline and Week 24
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) of 0 or 1 At Week 12 Among Those With Baseline DLQI >1
DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of atopic dermatitis (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.
Measured: Baseline and Week 12
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) of 0 or 1 At Week 24 Among Those With Baseline DLQI >1
DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of atopic dermatitis (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.
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start29 May 2023
- Primary completion11 Jul 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507580
- Sponsor's protocol ID
- M22-000
- Other IDs
- 2022-000434-42
- Acronym
- Flex-Up
- Status last verified
- Jul 2025
- First submitted
- 18 Aug 2022
- Last updated
- 29 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.