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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
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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
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Secondary ID [1]
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2023-505061-82-00
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Secondary ID [2]
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M23-716
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Universal Trial Number (UTN)
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Trial acronym
Up-AA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alopecia Areata
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Condition category
Condition code
Inflammatory and Immune System
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Autoimmune diseases
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20
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Assessment method [1]
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The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
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Timepoint [1]
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Week 24
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Primary outcome [2]
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Number of Participants with Adverse Events (AEs)
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Assessment method [2]
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An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
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Timepoint [2]
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Up to approximately 164 weeks
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Secondary outcome [1]
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Achievement of SALT score <= 20 for the Comparison of Upadacitinib Dose A QD Versus Placebo
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Assessment method [1]
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The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
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Timepoint [1]
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Week 24
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Secondary outcome [2]
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Percentage of Participants with the Achievement of SALT Score <= 10
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Assessment method [2]
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The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
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Timepoint [2]
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Up to Week 24
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Secondary outcome [3]
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Percentage of Participants with the Achievement of SALT Score <= 20
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Assessment method [3]
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The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
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Timepoint [3]
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Up to Week 12
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Secondary outcome [4]
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Percentage of Participants with the Achievement of Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss of 0 or 1
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Assessment method [4]
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The ClinRO for Eyebrow Hair Loss is a 4-point response scale where 0 = The eyebrows have full coverage and no areas of hair loss and 3 = No notable eyebrows. Responses should have a = 2-point improvement from Baseline among participants with Baseline score = 2.
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Timepoint [4]
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Baseline to Week 24
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Secondary outcome [5]
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Percentage of Participants with the Achievement of ClinRO Measure for Eyelash Hair Loss of 0 or 1
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Assessment method [5]
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The ClinRO for Eyelash Hair Loss is a 4-point response scale where 0 = The eyelashes form a continuous line along the eyelids on both eyes and 3 = No notable eyelashes. Responses should have a = 2-point improvement from Baseline among participants with Baseline score = 2.
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Timepoint [5]
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Baseline to Week 24
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Secondary outcome [6]
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Percentage of Participants with the Achievement of SALT 75
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Assessment method [6]
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SALT 75 is defined as at least a 75% improvement \[decrease\] from Baseline in SALT score.
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Timepoint [6]
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Baseline to Week 24
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Secondary outcome [7]
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Percentage of Participants with the Achievement of SALT 90
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Assessment method [7]
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SALT 90 is defined as at least a 90% improvement \[decrease\] from Baseline in SALT score.
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Timepoint [7]
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Baseline to Week 24
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Secondary outcome [8]
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Percent Change from Baseline in SALT Score
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Assessment method [8]
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The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
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Timepoint [8]
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Baseline to Week 24
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Secondary outcome [9]
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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"
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Assessment method [9]
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The PaGIC-AA is a single-item measure that asks participants to rate how their alopecia condition has changed overall since the start of the study using a 7-point scale. Responses range from "much better" to "much worse."
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Timepoint [9]
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Up to Week 24
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Secondary outcome [10]
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Percentage of Participants with the Achievement of Patient-Reported Outcome (PRO) for Scalp Hair Assessment 0/1 with = 2-Point Improvement (Reduction)
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Assessment method [10]
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The PRO for Scalp Hair Assessment is single item, five-point, categorical response scale that asks respondents to look in the mirror and assess the total area of the scalp with missing hair. Response items range from "No missing hair" to "Nearly all or all" and includes percentage ranges for each category (0%, 1 to 20%, 21 to 49%, 50 to 94%, and 95 to 100%). Responses among participants with baseline score \>=3.
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Timepoint [10]
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Baseline to Week 24
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Secondary outcome [11]
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Change from Baseline in Alopecia Areata Symptom Impact Scale (AASIS) Interference Subscale Score
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Assessment method [11]
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The AASIS Interference Subscale is a 6-item assessment with scores ranging from 0 = 'did not interfere' to 10 = 'interfered completely' with higher scores indicating greater symptom interference.
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Timepoint [11]
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Week 24
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Secondary outcome [12]
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Change from Baseline in AASIS Symptoms Subscale Score
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Assessment method [12]
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The AASIS Symptom Subscale is a 7-item assessment with scores ranging from 0 = 'not present' to 10 = 'as bad as you can imagine' with higher scores indicating greater symptom severity.
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Timepoint [12]
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Week 24
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Secondary outcome [13]
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Change from Baseline in Skindex-16 AA Emotions Domain Scores
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Assessment method [13]
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The Skindex-16 AA Emotions Domain is a 7-item assessment ranging from 0 = never bothered to 6 = always bothered that measures the effects of AA on a subject's health-related quality of life. Higher scores indicate greater impact on health-related quality of life.
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Timepoint [13]
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Week 24
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Secondary outcome [14]
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Change from Baseline in Skindex-16 AA Functioning Domain Scores
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Assessment method [14]
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The Skindex-16 AA Emotions Domain is a 5-item assessment ranging from 0 = never bothered to 6 = always bothered, that measures the effects of AA on a subject's health-related quality of life. Higher scores indicate greater impact on health-related quality of life.
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Timepoint [14]
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Week 24
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Secondary outcome [15]
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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
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Assessment method [15]
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The HADS is a self-administered scale which measures anxiety and depression. It contains 14 items and is comprised of anxiety (7 items) and depression (7 items) subscales, which are scored separately and summed to give a total score. Item scores range from 0 (best) to 3 (worst), and total scores are categorized as normal (0 to 7), borderline abnormal (8 to 10), and abnormal (11 to 21).
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Timepoint [15]
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Baseline to Week 24
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Secondary outcome [16]
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Percentage of Participants with the Achievement of SALT Score 0
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Assessment method [16]
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The SALT is a global AA severity score based on the combination of extent and density of scalp hair loss. The score is determined by visually defining the amount of terminal hair loss in each of the 4 views of the scalp (left and right side each accounting for 18% of scalp area, the top for 40%, and the back for 24%) and adding these together with a maximum score of 100%.
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Timepoint [16]
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Week 24
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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.
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Minimum age
12
Years
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Maximum age
63
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Other
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/10/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
3/01/2028
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Actual
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Sample size
Target
1500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Holdsworth House Medical Practice /ID# 258571 - Darlinghurst
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Recruitment hospital [2]
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St George Dermatology & Skin Cancer Centre /ID# 258567 - Kogarah
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Recruitment hospital [3]
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Cornerstone Dermatology /ID# 258769 - Coorparoo
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Veracity Clinical Research /ID# 258566 - Woolloongabba
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Recruitment hospital [5]
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Skin Health Institute Inc /ID# 258570 - Carlton
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Recruitment hospital [6]
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Sinclair Dermatology - Melbourne /ID# 258565 - East Melbourne
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Recruitment hospital [7]
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The Royal Melbourne Hospital /ID# 258770 - Parkville
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Recruitment hospital [8]
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Fremantle Dermatology /ID# 260207 - Fremantle
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2217 - Kogarah
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Recruitment postcode(s) [3]
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4151 - Coorparoo
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Recruitment postcode(s) [4]
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4102 - Woolloongabba
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Recruitment postcode(s) [5]
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3053 - Carlton
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Recruitment postcode(s) [6]
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3002 - East Melbourne
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Recruitment postcode(s) [7]
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3050 - Parkville
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Recruitment postcode(s) [8]
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6160 - Fremantle
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Recruitment outside Australia
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United States of America
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Alabama
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Florida
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Georgia
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Illinois
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Indiana
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Massachusetts
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Argentina
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Ciudad Autonoma De Buenos Aires
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Rio Grande Do Sul
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Sao Paulo
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Brazil
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Sofiya
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Stara Zagora
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Chile
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Region Metropolitana De Santiago
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Chile
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Region Metropolitana Santiago
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Chile
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Santiago
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China
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Beijing
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Guangdong
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Guizhou
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Jiangxi
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China
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Jilin
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China
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Shaanxi
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China
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Shanghai
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China
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Shanxi
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China
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Sichuan
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China
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Tianjin
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China
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Zhejiang
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Croatia
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Grad Zagreb
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Croatia
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Splitsko-dalmatinska Zupanija
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Croatia
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Rijeka
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France
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Alpes-Maritimes
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France
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France
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France
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Rhone
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France
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Brest
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France
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Paris
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France
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Rouen
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France
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Toulouse
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Germany
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Nordrhein-Westfalen
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Germany
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Saarland
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Germany
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Schleswig-Holstein
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Germany
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Berlin
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Germany
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Munich
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Greece
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Attiki
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Greece
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Evrytania
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Hungary
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Bacs-Kiskun
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Hungary
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Csongrad
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Hungary
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Hajdu-Bihar
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Hungary
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Nograd
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Hungary
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Debrecen
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Hungary
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Kecskemet
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Israel
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Tel-Aviv
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Israel
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Yerushalayim
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Israel
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Haifa
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Italy
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Firenze
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Italy
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L Aquila
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Italy
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Milano
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Italy
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Roma
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Italy
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Catania
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Japan
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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
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Japan
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Shizuoka
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Japan
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Tokyo
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Japan
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Yamaguchi
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Japan
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Mitaka
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Korea, Republic of
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Busan Gwang Yeogsi
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Korea, Republic of
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Daegu Gwang Yeogsi
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Incheon Gwang Yeogsi
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
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Seoul
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New Zealand
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Auckland
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New Zealand
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Manawatu-Wanganui
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Poland
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Kujawsko-pomorskie
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Podlaskie
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Pomorskie
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Slaskie
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Warminsko-mazurskie
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Cracow
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Portugal
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Regiao Autonoma Da Madeira
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Portugal
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Almada
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Portugal
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Porto
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Puerto Rico
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Bayamon
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Puerto Rico
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Caguas
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Puerto Rico
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San Juan
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Slovakia
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Bratislavsky Kraj
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Slovakia
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Topolcany
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Barcelona
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Spain
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Cordoba
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Spain
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Madrid
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Spain
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Valencia
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Sweden
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Stockholms Lan
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Sweden
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Vastra Gotalands Lan
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Kaohsiung
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Taiwan
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Keelung
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Taiwan
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Taipei
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Taiwan
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Taoyuan City
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Turkey
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Adana
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Turkey
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Istanbul
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Turkey
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Kayseri
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United Kingdom
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Bolton
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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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Harrow
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United Kingdom
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London
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United Kingdom
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Salford
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT06012240
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
ABBVIE INC.
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Address
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AbbVie
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Country
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0
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Phone
0
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Fax
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Email
0
0
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Contact person for public queries
Name
0
0
ABBVIE CALL CENTER
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Address
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0
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Country
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0
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Phone
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0
844-663-3742
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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)
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When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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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/
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Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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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