Register a trial

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/NCT06012240




Registration number
NCT06012240
Ethics application status
Date submitted
22/08/2023
Date registered
25/08/2023

Titles & IDs
Public title
A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata
Scientific title
A Phase 3 Randomized, Placebo-controlled, Double-blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Severe Alopecia Areata
Secondary ID [1] 0 0
2023-505061-82-00
Secondary ID [2] 0 0
M23-716
Universal Trial Number (UTN)
Trial acronym
Up-AA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alopecia Areata 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Other skin conditions

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

Experimental: Study 1: Group 1 Upadacitinib Dose A - Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.

Experimental: Study 1: Group 2 Upadacitinib Dose B - Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.

Experimental: Study 1: Group 3 Placebo - Participants will receive matching placebo once daily for 24 weeks in Period A.

Experimental: Study 1: Group 4 Upadacitinib Dose A - Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.

Experimental: Study 1: Group 5 Upadacitinib Dose B - Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.

Experimental: Study 1: Group 6 Placebo - Participants initially randomized to placebo with a SALT score = 20 at Week 24 will continue on placebo through Week 160.

Experimental: Study 2: Group 1 Upadacitinib Dose A - Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.

Experimental: Study 2: Group 2 Upadacitinib Dose B - Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.

Experimental: Study 2: Group 3 Placebo - Participants will receive matching placebo once daily for 24 weeks in Period A.

Experimental: Study 2: Group 4 Upadacitinib Dose A - Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.

Experimental: Study 2: Group 5 Upadacitinib Dose B - Participants initially randomized to placebo (Period A) with a SALT score \> 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.

Experimental: Study 2: Group 6 Placebo - Participants initially randomized to placebo with a SALT score = 20 at Week 24 will continue on placebo through Week 160.

Experimental: Study 3: Group 1 Upadacitinib Dose B (SALT > 20) - Participants receiving upadacitinib Dose A with a SALT score \> 20 at Week 52 (end of Period B) of Study 1 or Study 2 will dose escalate to upadacitinib Dose B once daily for 108 weeks.

Experimental: Study 3: Group 2 Upadacitinib Dose A (SALT = 20) - Participants receiving upadacitinib Dose A with a SALT score = 20 at Week 52 (end of Period B) of Study 1 or Study 2 will remain on upadacitinib Dose A once daily for 108 weeks.

Experimental: Study 3: Group 3 Upadacitinib Dose B (Non-Sustained) - Participants who end Period B on upadacitinib Dose B with a with a SALT score \> 20 at Week 40 or Week 52 of Study 1 or Study 2 will remain on upadacitinib Dose B once daily for 108 weeks.

Experimental: Study 3: Group 4 Upadacitinib Dose B (Sustained) - Participants who end Period B on upadacitinib Dose B with a with a SALT score = 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose B once daily for 108 weeks.

Experimental: Study 3: Group 5 Upadacitinib Dose A (Sustained) - Participants who end Period B on upadacitinib Dose B with a with a SALT score = 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose A once daily for 108 weeks.


Treatment: Drugs: Upadacitinib
Oral Tablets

Treatment: Drugs: Placebo
Oral Tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20
Timepoint [1] 0 0
Week 24
Primary outcome [2] 0 0
Number of Participants with Adverse Events (AEs)
Timepoint [2] 0 0
Up to approximately 164 weeks
Secondary outcome [1] 0 0
Achievement of SALT score <= 20 for the Comparison of Upadacitinib Dose A QD Versus Placebo
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Percentage of Participants with the Achievement of SALT Score <= 10
Timepoint [2] 0 0
Up to Week 24
Secondary outcome [3] 0 0
Percentage of Participants with the Achievement of SALT Score <= 20
Timepoint [3] 0 0
Up to Week 12
Secondary outcome [4] 0 0
Percentage of Participants with the Achievement of Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss of 0 or 1
Timepoint [4] 0 0
Baseline to Week 24
Secondary outcome [5] 0 0
Percentage of Participants with the Achievement of ClinRO Measure for Eyelash Hair Loss of 0 or 1
Timepoint [5] 0 0
Baseline to Week 24
Secondary outcome [6] 0 0
Percentage of Participants with the Achievement of SALT 75
Timepoint [6] 0 0
Baseline to Week 24
Secondary outcome [7] 0 0
Percentage of Participants with the Achievement of SALT 90
Timepoint [7] 0 0
Baseline to Week 24
Secondary outcome [8] 0 0
Percent Change from Baseline in SALT Score
Timepoint [8] 0 0
Baseline to Week 24
Secondary outcome [9] 0 0
Percentage of Participants with the Achievement of Patients' Global Impression of Change of Alopecia Areata (PaGIC-AA) Score of 1 "Much Better" or 2 "Moderately Better"
Timepoint [9] 0 0
Up to Week 24
Secondary outcome [10] 0 0
Percentage of Participants with the Achievement of Patient-Reported Outcome (PRO) for Scalp Hair Assessment 0/1 with = 2-Point Improvement (Reduction)
Timepoint [10] 0 0
Baseline to Week 24
Secondary outcome [11] 0 0
Change from Baseline in Alopecia Areata Symptom Impact Scale (AASIS) Interference Subscale Score
Timepoint [11] 0 0
Week 24
Secondary outcome [12] 0 0
Change from Baseline in AASIS Symptoms Subscale Score
Timepoint [12] 0 0
Week 24
Secondary outcome [13] 0 0
Change from Baseline in Skindex-16 AA Emotions Domain Scores
Timepoint [13] 0 0
Week 24
Secondary outcome [14] 0 0
Change from Baseline in Skindex-16 AA Functioning Domain Scores
Timepoint [14] 0 0
Week 24
Secondary outcome [15] 0 0
Achievement of Hospital Anxiety and Depression Scale (HADS)-Anxiety < 8 and HADS-Depression < 8 at Week 24 Among Participants with HADS-A >= 8 or HADS-D >= 8 at Baseline
Timepoint [15] 0 0
Baseline to Week 24
Secondary outcome [16] 0 0
Percentage of Participants with the Achievement of SALT Score 0
Timepoint [16] 0 0
Week 24

Eligibility
Key inclusion criteria
* Adult individuals must be < 64 years old at Baseline Visit. Where permitted outside United States (US)/European Union (EU), adolescent individuals who are at least 12 years old at Screening may participate.
* Diagnosis of severe alopecia areata (AA) with Severity of Alopecia Tool (SALT) score >= 50 scalp hair loss at Screening and Baseline.
* Severe AA with no spontaneous scalp hair regrowth over the past 6 months.
* Current episode of AA of less than 8 years.
Minimum age
12 Years
Maximum age
63 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current diagnosis of primarily diffuse type of AA.
* Current diagnosis of other types of alopecia that would interfere with evaluation of AA, including but not limited to female pattern hair loss, male pattern hair loss (androgenetic alopecia) Stage III or greater based on Hamilton-Norwood classification, traction alopecia, lichen planopilaris (LPP), discoid lupus, frontal fibrosing alopecia (FFA), central centrifugal cicatricial alopecia (CCCA), folliculitis decalvans, trichotillomania, and telogen effluvium.
* Diagnosis of other types of inflammatory scalp, eyebrow, or eyelash disorders that would interfere with evaluation of AA as determined by the investigator, including but not limited to seborrheic dermatitis, scalp psoriasis, atopic dermatitis (AD), and tinea capitis.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/01/2028
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice /ID# 258571 - Darlinghurst
Recruitment hospital [2] 0 0
St George Dermatology & Skin Cancer Centre /ID# 258567 - Kogarah
Recruitment hospital [3] 0 0
Cornerstone Dermatology /ID# 258769 - Coorparoo
Recruitment hospital [4] 0 0
Veracity Clinical Research /ID# 258566 - Woolloongabba
Recruitment hospital [5] 0 0
Skin Health Institute Inc /ID# 258570 - Carlton
Recruitment hospital [6] 0 0
Sinclair Dermatology - Melbourne /ID# 258565 - East Melbourne
Recruitment hospital [7] 0 0
The Royal Melbourne Hospital /ID# 258770 - Parkville
Recruitment hospital [8] 0 0
Fremantle Dermatology /ID# 260207 - Fremantle
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
4151 - Coorparoo
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3053 - Carlton
Recruitment postcode(s) [6] 0 0
3002 - East Melbourne
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment postcode(s) [8] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
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
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Nebraska
Country [15] 0 0
United States of America
State/province [15] 0 0
Nevada
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oregon
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
South Dakota
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
Argentina
State/province [23] 0 0
Ciudad Autonoma De Buenos Aires
Country [24] 0 0
Argentina
State/province [24] 0 0
Buenos Aires
Country [25] 0 0
Argentina
State/province [25] 0 0
Cordoba
Country [26] 0 0
Brazil
State/province [26] 0 0
Rio Grande Do Sul
Country [27] 0 0
Brazil
State/province [27] 0 0
Sao Paulo
Country [28] 0 0
Brazil
State/province [28] 0 0
Rio de Janeiro
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
British Columbia
Country [34] 0 0
Canada
State/province [34] 0 0
Manitoba
Country [35] 0 0
Canada
State/province [35] 0 0
Ontario
Country [36] 0 0
Canada
State/province [36] 0 0
Quebec
Country [37] 0 0
Chile
State/province [37] 0 0
Region Metropolitana De Santiago
Country [38] 0 0
Chile
State/province [38] 0 0
Region Metropolitana Santiago
Country [39] 0 0
Chile
State/province [39] 0 0
Santiago
Country [40] 0 0
China
State/province [40] 0 0
Beijing
Country [41] 0 0
China
State/province [41] 0 0
Guangdong
Country [42] 0 0
China
State/province [42] 0 0
Guizhou
Country [43] 0 0
China
State/province [43] 0 0
Hubei
Country [44] 0 0
China
State/province [44] 0 0
Jiangxi
Country [45] 0 0
China
State/province [45] 0 0
Jilin
Country [46] 0 0
China
State/province [46] 0 0
Shaanxi
Country [47] 0 0
China
State/province [47] 0 0
Shanghai
Country [48] 0 0
China
State/province [48] 0 0
Shanxi
Country [49] 0 0
China
State/province [49] 0 0
Sichuan
Country [50] 0 0
China
State/province [50] 0 0
Tianjin
Country [51] 0 0
China
State/province [51] 0 0
Zhejiang
Country [52] 0 0
Croatia
State/province [52] 0 0
Grad Zagreb
Country [53] 0 0
Croatia
State/province [53] 0 0
Splitsko-dalmatinska Zupanija
Country [54] 0 0
Croatia
State/province [54] 0 0
Rijeka
Country [55] 0 0
France
State/province [55] 0 0
Alpes-Maritimes
Country [56] 0 0
France
State/province [56] 0 0
Bretagne
Country [57] 0 0
France
State/province [57] 0 0
Gironde
Country [58] 0 0
France
State/province [58] 0 0
Rhone
Country [59] 0 0
France
State/province [59] 0 0
Brest
Country [60] 0 0
France
State/province [60] 0 0
Paris
Country [61] 0 0
France
State/province [61] 0 0
Rouen
Country [62] 0 0
France
State/province [62] 0 0
Toulouse
Country [63] 0 0
Germany
State/province [63] 0 0
Nordrhein-Westfalen
Country [64] 0 0
Germany
State/province [64] 0 0
Saarland
Country [65] 0 0
Germany
State/province [65] 0 0
Schleswig-Holstein
Country [66] 0 0
Germany
State/province [66] 0 0
Berlin
Country [67] 0 0
Germany
State/province [67] 0 0
Munich
Country [68] 0 0
Greece
State/province [68] 0 0
Attiki
Country [69] 0 0
Greece
State/province [69] 0 0
Evrytania
Country [70] 0 0
Hungary
State/province [70] 0 0
Bacs-Kiskun
Country [71] 0 0
Hungary
State/province [71] 0 0
Csongrad
Country [72] 0 0
Hungary
State/province [72] 0 0
Hajdu-Bihar
Country [73] 0 0
Hungary
State/province [73] 0 0
Nograd
Country [74] 0 0
Hungary
State/province [74] 0 0
Debrecen
Country [75] 0 0
Hungary
State/province [75] 0 0
Kecskemet
Country [76] 0 0
Israel
State/province [76] 0 0
Tel-Aviv
Country [77] 0 0
Israel
State/province [77] 0 0
Yerushalayim
Country [78] 0 0
Israel
State/province [78] 0 0
Haifa
Country [79] 0 0
Italy
State/province [79] 0 0
Firenze
Country [80] 0 0
Italy
State/province [80] 0 0
L Aquila
Country [81] 0 0
Italy
State/province [81] 0 0
Milano
Country [82] 0 0
Italy
State/province [82] 0 0
Roma
Country [83] 0 0
Italy
State/province [83] 0 0
Catania
Country [84] 0 0
Japan
State/province [84] 0 0
Fukuoka
Country [85] 0 0
Japan
State/province [85] 0 0
Kanagawa
Country [86] 0 0
Japan
State/province [86] 0 0
Niigata
Country [87] 0 0
Japan
State/province [87] 0 0
Osaka
Country [88] 0 0
Japan
State/province [88] 0 0
Shizuoka
Country [89] 0 0
Japan
State/province [89] 0 0
Tokyo
Country [90] 0 0
Japan
State/province [90] 0 0
Yamaguchi
Country [91] 0 0
Japan
State/province [91] 0 0
Mitaka
Country [92] 0 0
Korea, Republic of
State/province [92] 0 0
Busan Gwang Yeogsi
Country [93] 0 0
Korea, Republic of
State/province [93] 0 0
Daegu Gwang Yeogsi
Country [94] 0 0
Korea, Republic of
State/province [94] 0 0
Gyeonggido
Country [95] 0 0
Korea, Republic of
State/province [95] 0 0
Incheon Gwang Yeogsi
Country [96] 0 0
Korea, Republic of
State/province [96] 0 0
Seoul Teugbyeolsi
Country [97] 0 0
Korea, Republic of
State/province [97] 0 0
Seoul
Country [98] 0 0
New Zealand
State/province [98] 0 0
Auckland
Country [99] 0 0
New Zealand
State/province [99] 0 0
Manawatu-Wanganui
Country [100] 0 0
Poland
State/province [100] 0 0
Kujawsko-pomorskie
Country [101] 0 0
Poland
State/province [101] 0 0
Malopolskie
Country [102] 0 0
Poland
State/province [102] 0 0
Mazowieckie
Country [103] 0 0
Poland
State/province [103] 0 0
Podlaskie
Country [104] 0 0
Poland
State/province [104] 0 0
Pomorskie
Country [105] 0 0
Poland
State/province [105] 0 0
Slaskie
Country [106] 0 0
Poland
State/province [106] 0 0
Warminsko-mazurskie
Country [107] 0 0
Poland
State/province [107] 0 0
Cracow
Country [108] 0 0
Portugal
State/province [108] 0 0
Regiao Autonoma Da Madeira
Country [109] 0 0
Portugal
State/province [109] 0 0
Almada
Country [110] 0 0
Portugal
State/province [110] 0 0
Porto
Country [111] 0 0
Puerto Rico
State/province [111] 0 0
Bayamon
Country [112] 0 0
Puerto Rico
State/province [112] 0 0
Caguas
Country [113] 0 0
Puerto Rico
State/province [113] 0 0
San Juan
Country [114] 0 0
Slovakia
State/province [114] 0 0
Bratislavsky Kraj
Country [115] 0 0
Slovakia
State/province [115] 0 0
Topolcany
Country [116] 0 0
Spain
State/province [116] 0 0
Barcelona
Country [117] 0 0
Spain
State/province [117] 0 0
Cordoba
Country [118] 0 0
Spain
State/province [118] 0 0
Madrid
Country [119] 0 0
Spain
State/province [119] 0 0
Valencia
Country [120] 0 0
Sweden
State/province [120] 0 0
Stockholms Lan
Country [121] 0 0
Sweden
State/province [121] 0 0
Vastra Gotalands Lan
Country [122] 0 0
Taiwan
State/province [122] 0 0
Kaohsiung
Country [123] 0 0
Taiwan
State/province [123] 0 0
Keelung
Country [124] 0 0
Taiwan
State/province [124] 0 0
Taipei
Country [125] 0 0
Taiwan
State/province [125] 0 0
Taoyuan City
Country [126] 0 0
Turkey
State/province [126] 0 0
Adana
Country [127] 0 0
Turkey
State/province [127] 0 0
Istanbul
Country [128] 0 0
Turkey
State/province [128] 0 0
Kayseri
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Bolton
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Buckinghamshire
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Oxfordshire
Country [132] 0 0
United Kingdom
State/province [132] 0 0
West Sussex
Country [133] 0 0
United Kingdom
State/province [133] 0 0
Harrow
Country [134] 0 0
United Kingdom
State/province [134] 0 0
London
Country [135] 0 0
United Kingdom
State/province [135] 0 0
Salford

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06012240