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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06012240




Registration number
NCT06012240
Ethics application status
Date submitted
22/08/2023
Date registered
25/08/2023
Date last updated
23/05/2024

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
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
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 Skindex-16 AA Emotions Domain Scores
Timepoint [11] 0 0
Week 24
Secondary outcome [12] 0 0
Change from Baseline in Skindex-16 AA Functioning Domain Scores
Timepoint [12] 0 0
Week 24
Secondary outcome [13] 0 0
Change from Baseline in Alopecia Areata Symptom Impact Scale (AASIS) Interference Subscale Score
Timepoint [13] 0 0
Week 24
Secondary outcome [14] 0 0
Change from Baseline in AASIS Symptoms Subscale Score
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 (OUS), 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 AND no
significant scalp hair loss over the past 3 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
- Diagnosis of primarily diffuse type of AA.

- 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, 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
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
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
Nevada
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
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
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
Brazil
State/province [21] 0 0
Rio Grande Do Sul
Country [22] 0 0
Brazil
State/province [22] 0 0
Rio de Janeiro
Country [23] 0 0
Brazil
State/province [23] 0 0
Sao Paulo
Country [24] 0 0
Canada
State/province [24] 0 0
British Columbia
Country [25] 0 0
Canada
State/province [25] 0 0
Manitoba
Country [26] 0 0
Canada
State/province [26] 0 0
Ontario
Country [27] 0 0
Canada
State/province [27] 0 0
Quebec
Country [28] 0 0
Chile
State/province [28] 0 0
Santiago
Country [29] 0 0
China
State/province [29] 0 0
Beijing
Country [30] 0 0
China
State/province [30] 0 0
Guangdong
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China
State/province [31] 0 0
Jiangxi
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China
State/province [32] 0 0
Jilin
Country [33] 0 0
China
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Shanghai
Country [34] 0 0
China
State/province [34] 0 0
Shanxi
Country [35] 0 0
China
State/province [35] 0 0
Sichuan
Country [36] 0 0
China
State/province [36] 0 0
Tianjin
Country [37] 0 0
China
State/province [37] 0 0
Zhejiang
Country [38] 0 0
China
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Chongqing
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Japan
State/province [39] 0 0
Fukuoka
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Japan
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Kanagawa
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Japan
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Niigata
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Japan
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Osaka
Country [43] 0 0
Japan
State/province [43] 0 0
Shizuoka
Country [44] 0 0
Japan
State/province [44] 0 0
Tokyo
Country [45] 0 0
Japan
State/province [45] 0 0
Yamaguchi
Country [46] 0 0
Japan
State/province [46] 0 0
Mitaka
Country [47] 0 0
Korea, Republic of
State/province [47] 0 0
Seoul
Country [48] 0 0
New Zealand
State/province [48] 0 0
Auckland
Country [49] 0 0
New Zealand
State/province [49] 0 0
Hamilton
Country [50] 0 0
New Zealand
State/province [50] 0 0
Wellington
Country [51] 0 0
Puerto Rico
State/province [51] 0 0
Bayamon
Country [52] 0 0
Puerto Rico
State/province [52] 0 0
Caguas
Country [53] 0 0
Puerto Rico
State/province [53] 0 0
San Juan
Country [54] 0 0
United Kingdom
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Buckinghamshire
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United Kingdom
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Oxfordshire
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United Kingdom
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West Sussex
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United Kingdom
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Gloucester
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United Kingdom
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Harrow
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United Kingdom
State/province [59] 0 0
London
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United Kingdom
State/province [60] 0 0
Salford

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

Ethics approval
Ethics application status

Summary
Brief summary
Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles
and causes hair loss. AA usually affects the head and face, but hair loss can happen on any
part of the body. The purpose of this study is to assess how safe, effective, and tolerable
upadacitinib is in adolescent and adult participants with severe AA.

Upadacitinib is an approved drug being investigated for the treatment of AA. In Study 1 and
Study 2 Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group
receives a different treatment. There is a 1 in 5 chance that participants will be assigned
to placebo. In Study 1 and Study 2 Period B, participants originally randomized to
upadacitinib dose group in Period A will continue their same treatment in Period B.
Participants originally randomized to Placebo in Period A will either remain on placebo in
Period B, or be randomized in 1 of 2 groups, based off of their Severity of Alopecia Tool
(SALT) score. Participants who complete Study 1 or Study 2, can join Study 3 and may be
re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. Around 1500
participants with severe AA will be enrolled in the study at approximately 240 sites
worldwide.

Participants will receive oral tablets of either upadacitinib or placebo once daily for up to
160 weeks with the potential of being re-randomized into a different treatment group at Weeks
24 and 52. Participants will be followed up for up to 30 days after last study drug dose.

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/ct2/show/NCT06012240
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
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06012240