Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05601882




Registration number
NCT05601882
Ethics application status
Date submitted
31/10/2022
Date registered
1/11/2022
Date last updated
21/08/2024

Titles & IDs
Public title
A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
Scientific title
A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects With Moderate to Severe Atopic Dermatitis (Level-Up)
Secondary ID [1] 0 0
2022-002482-15
Secondary ID [2] 0 0
M23-696
Universal Trial Number (UTN)
Trial acronym
Level Up
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Upadacitinib
Treatment: Drugs - Dupilumab

Experimental: Upadacitinib - Participants will receive upadacitinib dose A daily in period 1. Eligible participants will receive upadacitinib dose B daily in period 2.

Experimental: Dupilumab followed by Upadacitinib - Participants will receive dupilumab as per its label in period 1. Eligible participants will receive upadacitinib dose A in period 2.


Treatment: Drugs: Upadacitinib
Oral Tablets

Treatment: Drugs: Dupilumab
Subcutaneous Injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving both 90% Eczema Area and Severity Index (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WPNRS 0/1)
Timepoint [1] 0 0
At week 16
Secondary outcome [1] 0 0
Percentage of Participants Achieving at least 90% of Eczema Area and Severity Index (EASI 90)
Timepoint [1] 0 0
Up to week 16
Secondary outcome [2] 0 0
Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) among Participants with Baseline WP-NRS > 1
Timepoint [2] 0 0
Up to week 16
Secondary outcome [3] 0 0
Percentage of Participants Achieving an improvement in Worst Pruritus Numerical Rating Scale (WP-NRS) = 4 among those with Baseline WP-NRS = 4
Timepoint [3] 0 0
At week 16
Secondary outcome [4] 0 0
Percentage of Participants Achieving 75% of Eczema Area and Severity Index (EASI 75)
Timepoint [4] 0 0
At week 2
Secondary outcome [5] 0 0
Percentage of Participants Achieving 100% of Eczema Area and Severity Index (EASI 100)
Timepoint [5] 0 0
At week 16

Eligibility
Key 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;validated Investigator´s Global Assessment for AD (vIGA-AD) score = 3 and = 10% Body Surface Area Involvement of Atopic Dermatitis (BSA of AD) involvement at the Baseline Visit.
* Baseline weekly average of daily Worst Pruritus Numerical Rating Scale (WP-NRS) = 4.
* Documented history of inadequate response to previous systemic treatment defined as documented history of previous inadequate response to at least one prior systemic treatment for AD OR for whom other systemic treatments are otherwise medically inadvisable.
Minimum age
12 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
* History of an organ transplant which requires continued immunosuppression.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/08/2024
Sample size
Target
Accrual to date
Final
926
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Premier Specialist /ID# 250572 - Kogarah
Recruitment hospital [2] 0 0
Veracity Clinical Research /ID# 249943 - Woolloongabba
Recruitment hospital [3] 0 0
Skin Health Institute Inc /ID# 249938 - Carlton
Recruitment hospital [4] 0 0
Sinclair Dermatology - Melbourne /ID# 249937 - East Melbourne
Recruitment hospital [5] 0 0
Fremantle Dermatology /ID# 249941 - Fremantle
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3053 - Carlton
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
South Dakota
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
Belgium
State/province [24] 0 0
Bruxelles-Capitale
Country [25] 0 0
Belgium
State/province [25] 0 0
Hainaut
Country [26] 0 0
Belgium
State/province [26] 0 0
Vlaams-Brabant
Country [27] 0 0
Belgium
State/province [27] 0 0
Liege
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Smolyan
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Sofia
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Plovdiv
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Sofiya
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Stara Zagora
Country [33] 0 0
Canada
State/province [33] 0 0
Alberta
Country [34] 0 0
Canada
State/province [34] 0 0
British Columbia
Country [35] 0 0
Canada
State/province [35] 0 0
Manitoba
Country [36] 0 0
Canada
State/province [36] 0 0
New Brunswick
Country [37] 0 0
Canada
State/province [37] 0 0
Ontario
Country [38] 0 0
Canada
State/province [38] 0 0
Quebec
Country [39] 0 0
China
State/province [39] 0 0
Fujian
Country [40] 0 0
China
State/province [40] 0 0
Guangdong
Country [41] 0 0
China
State/province [41] 0 0
Guizhou
Country [42] 0 0
China
State/province [42] 0 0
Hubei
Country [43] 0 0
China
State/province [43] 0 0
Liaoning
Country [44] 0 0
China
State/province [44] 0 0
Shanghai
Country [45] 0 0
China
State/province [45] 0 0
Tianjin
Country [46] 0 0
China
State/province [46] 0 0
Zhejiang
Country [47] 0 0
Croatia
State/province [47] 0 0
Grad Zagreb
Country [48] 0 0
Croatia
State/province [48] 0 0
Primorsko-goranska Zupanija
Country [49] 0 0
Croatia
State/province [49] 0 0
Splitsko-dalmatinska Zupanija
Country [50] 0 0
Denmark
State/province [50] 0 0
Hovedstaden
Country [51] 0 0
Denmark
State/province [51] 0 0
Midtjylland
Country [52] 0 0
Denmark
State/province [52] 0 0
Sjælland
Country [53] 0 0
France
State/province [53] 0 0
Bouches-du-Rhone
Country [54] 0 0
France
State/province [54] 0 0
Pays-de-la-Loire
Country [55] 0 0
France
State/province [55] 0 0
Rhone
Country [56] 0 0
France
State/province [56] 0 0
Paris
Country [57] 0 0
France
State/province [57] 0 0
Rouen
Country [58] 0 0
France
State/province [58] 0 0
Toulouse
Country [59] 0 0
Germany
State/province [59] 0 0
Baden-Wuerttemberg
Country [60] 0 0
Germany
State/province [60] 0 0
Brandenburg
Country [61] 0 0
Germany
State/province [61] 0 0
Hessen
Country [62] 0 0
Germany
State/province [62] 0 0
Niedersachsen
Country [63] 0 0
Germany
State/province [63] 0 0
Nordrhein-Westfalen
Country [64] 0 0
Germany
State/province [64] 0 0
Rheinland-Pfalz
Country [65] 0 0
Germany
State/province [65] 0 0
Saarland
Country [66] 0 0
Germany
State/province [66] 0 0
Sachsen
Country [67] 0 0
Germany
State/province [67] 0 0
Schleswig-Holstein
Country [68] 0 0
Germany
State/province [68] 0 0
Bochum
Country [69] 0 0
Germany
State/province [69] 0 0
Dresden
Country [70] 0 0
Germany
State/province [70] 0 0
Friedrichshafen
Country [71] 0 0
Germany
State/province [71] 0 0
Hamburg
Country [72] 0 0
Germany
State/province [72] 0 0
Munich
Country [73] 0 0
Greece
State/province [73] 0 0
Attiki
Country [74] 0 0
Greece
State/province [74] 0 0
Evrytania
Country [75] 0 0
Hungary
State/province [75] 0 0
Bacs-Kiskun
Country [76] 0 0
Hungary
State/province [76] 0 0
Hajdu-Bihar
Country [77] 0 0
Hungary
State/province [77] 0 0
Heves
Country [78] 0 0
Hungary
State/province [78] 0 0
Nograd
Country [79] 0 0
Hungary
State/province [79] 0 0
Somogy
Country [80] 0 0
Hungary
State/province [80] 0 0
Budapest
Country [81] 0 0
Hungary
State/province [81] 0 0
Debrecen
Country [82] 0 0
Hungary
State/province [82] 0 0
Szeged
Country [83] 0 0
Hungary
State/province [83] 0 0
Szolnok
Country [84] 0 0
Israel
State/province [84] 0 0
Yerushalayim
Country [85] 0 0
Israel
State/province [85] 0 0
Haifa
Country [86] 0 0
Italy
State/province [86] 0 0
L Aquila
Country [87] 0 0
Italy
State/province [87] 0 0
Milano
Country [88] 0 0
Italy
State/province [88] 0 0
Roma
Country [89] 0 0
Italy
State/province [89] 0 0
Umbria
Country [90] 0 0
Italy
State/province [90] 0 0
Brescia
Country [91] 0 0
Italy
State/province [91] 0 0
Florence
Country [92] 0 0
Italy
State/province [92] 0 0
Milan
Country [93] 0 0
Italy
State/province [93] 0 0
Modena
Country [94] 0 0
Italy
State/province [94] 0 0
Pisa
Country [95] 0 0
Japan
State/province [95] 0 0
Hokkaido
Country [96] 0 0
Japan
State/province [96] 0 0
Kanagawa
Country [97] 0 0
Japan
State/province [97] 0 0
Osaka
Country [98] 0 0
Japan
State/province [98] 0 0
Tokyo
Country [99] 0 0
Korea, Republic of
State/province [99] 0 0
Busan Gwang Yeogsi
Country [100] 0 0
Korea, Republic of
State/province [100] 0 0
Daegu Gwang Yeogsi
Country [101] 0 0
Korea, Republic of
State/province [101] 0 0
Gyeonggido
Country [102] 0 0
Korea, Republic of
State/province [102] 0 0
Seoul Teugbyeolsi
Country [103] 0 0
Mexico
State/province [103] 0 0
Baja California
Country [104] 0 0
Mexico
State/province [104] 0 0
Nuevo Leon
Country [105] 0 0
Mexico
State/province [105] 0 0
Mexico City
Country [106] 0 0
Mexico
State/province [106] 0 0
Tlalnepantla de Baz
Country [107] 0 0
Mexico
State/province [107] 0 0
Veracruz
Country [108] 0 0
Netherlands
State/province [108] 0 0
Noord-Brabant
Country [109] 0 0
Netherlands
State/province [109] 0 0
Noord-Holland
Country [110] 0 0
Poland
State/province [110] 0 0
Kujawsko-pomorskie
Country [111] 0 0
Poland
State/province [111] 0 0
Lodzkie
Country [112] 0 0
Poland
State/province [112] 0 0
Malopolskie
Country [113] 0 0
Poland
State/province [113] 0 0
Mazowieckie
Country [114] 0 0
Poland
State/province [114] 0 0
Podkarpackie
Country [115] 0 0
Poland
State/province [115] 0 0
Podlaskie
Country [116] 0 0
Poland
State/province [116] 0 0
Pomorskie
Country [117] 0 0
Poland
State/province [117] 0 0
Warminsko-mazurskie
Country [118] 0 0
Poland
State/province [118] 0 0
Wielkopolskie
Country [119] 0 0
Poland
State/province [119] 0 0
Cracow
Country [120] 0 0
Portugal
State/province [120] 0 0
Braga
Country [121] 0 0
Portugal
State/province [121] 0 0
Regiao Autonoma Da Madeira
Country [122] 0 0
Portugal
State/province [122] 0 0
Setubal
Country [123] 0 0
Portugal
State/province [123] 0 0
Leiria
Country [124] 0 0
Portugal
State/province [124] 0 0
Lisbon
Country [125] 0 0
Portugal
State/province [125] 0 0
Matosinhos
Country [126] 0 0
Portugal
State/province [126] 0 0
Porto
Country [127] 0 0
Puerto Rico
State/province [127] 0 0
Caguas
Country [128] 0 0
Puerto Rico
State/province [128] 0 0
Carolina
Country [129] 0 0
Puerto Rico
State/province [129] 0 0
San Juan
Country [130] 0 0
Romania
State/province [130] 0 0
Bucuresti
Country [131] 0 0
Romania
State/province [131] 0 0
Cluj
Country [132] 0 0
Slovakia
State/province [132] 0 0
Bratislavsky Kraj
Country [133] 0 0
Slovakia
State/province [133] 0 0
Bratislava
Country [134] 0 0
South Africa
State/province [134] 0 0
Gauteng
Country [135] 0 0
South Africa
State/province [135] 0 0
Kwazulu-Natal
Country [136] 0 0
South Africa
State/province [136] 0 0
Western Cape
Country [137] 0 0
Spain
State/province [137] 0 0
Barcelona
Country [138] 0 0
Spain
State/province [138] 0 0
Vizcaya
Country [139] 0 0
Spain
State/province [139] 0 0
Alicante
Country [140] 0 0
Spain
State/province [140] 0 0
Granada
Country [141] 0 0
Spain
State/province [141] 0 0
Madrid
Country [142] 0 0
Spain
State/province [142] 0 0
Sevilla
Country [143] 0 0
Spain
State/province [143] 0 0
Valencia
Country [144] 0 0
Sweden
State/province [144] 0 0
Skane Lan
Country [145] 0 0
Sweden
State/province [145] 0 0
Stockholms Lan
Country [146] 0 0
Sweden
State/province [146] 0 0
Vasterbottens Lan
Country [147] 0 0
Sweden
State/province [147] 0 0
Eskilstuna
Country [148] 0 0
Switzerland
State/province [148] 0 0
Sankt Gallen
Country [149] 0 0
Switzerland
State/province [149] 0 0
Bern
Country [150] 0 0
Taiwan
State/province [150] 0 0
Kaohsiung
Country [151] 0 0
Taiwan
State/province [151] 0 0
Keelung
Country [152] 0 0
Taiwan
State/province [152] 0 0
Taipei
Country [153] 0 0
Taiwan
State/province [153] 0 0
Hsinchu City
Country [154] 0 0
Taiwan
State/province [154] 0 0
New Taipei City
Country [155] 0 0
Taiwan
State/province [155] 0 0
Taipei City
Country [156] 0 0
Taiwan
State/province [156] 0 0
Taoyuan City
Country [157] 0 0
Turkey
State/province [157] 0 0
Adana
Country [158] 0 0
Turkey
State/province [158] 0 0
Ankara
Country [159] 0 0
Turkey
State/province [159] 0 0
Antalya
Country [160] 0 0
Turkey
State/province [160] 0 0
Bursa
Country [161] 0 0
Turkey
State/province [161] 0 0
Kayseri
Country [162] 0 0
Turkey
State/province [162] 0 0
Samsun

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
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 compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed.

Upadacitinib and dupilumab are approved drugs for the treatment of moderate to severe atopic dermatitis (AD). The study is comprised of a 35-day Screening Period, a 16-week treatment period 1 and a 16-week treatment period 2. During period 1, participants are randomly assigned in 1 of 2 groups, called treatment arms to receive upadacitinib Dose A or dupilumab. In Period 2, participants will receive upadacitinib Dose A or Dose B. Approximately 880 adolescent and adult participants ages 12 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 330 sites worldwide.

Participants will receive upadacitinib oral tablets once daily or dupilumab as per its label for 32 weeks and followed for 30 days.

There may be higher treatment burden for participants in this trial compared to their standard of care . 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.
Trial website
https://clinicaltrials.gov/study/NCT05601882
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05601882