A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata

NCT06012240
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,500
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Lead sponsor
AbbVie
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Start date
2023-10-11
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Number of sites
283
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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 and Study 4 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 and Study 4 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, Study 2 or Study 4, 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 280 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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Acronym
Up-AA
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Short 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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Official 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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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2030-04-01
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First posted
2023-08-25
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Registry last updated
2026-08-03
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Primary completion date
2030-04-01
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Start date
2023-10-11
clinicaltrials.gov

Participants
1,500
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Participant count basis
Estimated
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Planned participants
1,500
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Protocol amendments
5
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Number of sites
283
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
AbbVie
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06012240
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ClinicalTrials.gov ID
NCT06012240
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Registry record
Open registry record
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Allocation
Randomised
Model
Sequential
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20

    Timeframe: Week 24

    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%.

  2. Number of Participants with Adverse Events (AEs)

    Timeframe: Up to approximately 164 weeks

    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.

  1. Achievement of SALT score <= 20 for the Comparison of Upadacitinib Dose A QD Versus Placebo

    Timeframe: Week 24

    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%.

  2. Percentage of Participants with the Achievement of SALT Score <= 10

    Timeframe: Up to Week 24

    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%.

  3. Percentage of Participants with the Achievement of SALT Score <= 20

    Timeframe: Up to Week 12

    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%.

  4. Percentage of Participants with the Achievement of Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss of 0 or 1

    Timeframe: Baseline to Week 24

    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.

  5. Percentage of Participants with the Achievement of ClinRO Measure for Eyelash Hair Loss of 0 or 1

    Timeframe: Baseline to Week 24

    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.

  6. Percentage of Participants with the Achievement of SALT 75

    Timeframe: Baseline to Week 24

    SALT 75 is defined as at least a 75% improvement \[decrease\] from Baseline in SALT score.

  7. Percentage of Participants with the Achievement of SALT 90

    Timeframe: Baseline to Week 24

    SALT 90 is defined as at least a 90% improvement \[decrease\] from Baseline in SALT score.

  8. Percent Change from Baseline in SALT Score

    Timeframe: Baseline to Week 24

    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%.

  9. 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"

    Timeframe: Up to Week 24

    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."

  10. Percentage of Participants with the Achievement of Patient-Reported Outcome (PRO) for Scalp Hair Assessment 0/1 with ≥ 2-Point Improvement (Reduction)

    Timeframe: Baseline to Week 24

    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.

  11. Change from Baseline in Alopecia Areata Symptom Impact Scale (AASIS) Interference Subscale Score

    Timeframe: Week 24

    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.

  12. Change from Baseline in AASIS Symptoms Subscale Score

    Timeframe: Week 24

    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.

  13. Change from Baseline in Skindex-16 AA Emotions Domain Scores

    Timeframe: Week 24

    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.

  14. Change from Baseline in Skindex-16 AA Functioning Domain Scores

    Timeframe: Week 24

    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.

  15. 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

    Timeframe: Baseline to Week 24

    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).

  16. Percentage of Participants with the Achievement of SALT Score 0

    Timeframe: Week 24

    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%.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children, Adults
Minimum age
12 Years
Maximum age
63 Years
Healthy volunteers
No

  • 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 in Study 1 and Study 2. Adolescent individuals in the US who are at least 12 years old at Screening may participate in Study 4.
  • 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.

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Total Skin and Beauty Dermatology Center /ID# 259539Birmingham, United StatesActive, not recruiting
  • Duplicate_Advanced Research Associates - Glendale /ID# 259108Glendale, United StatesCompleted
  • Southwest Skin Specialists /ID# 258234Phoenix, United StatesCompleted
  • Alliance Dermatology and Mohs Center /ID# 258111Phoenix, United StatesActive, not recruiting
  • Johnson Dermatology Clinic /ID# 259103Fort Smith, United StatesActive, not recruiting
  • Exalt Clinical Research /ID# 283814Chula Vista, United StatesNot yet recruiting
  • Duplicate_JOSEPH RAOOF MD,INC /ID# 258031Encino, United StatesCompleted
  • First Oc Dermatology /ID# 259220Fountain Valley, United StatesRecruiting
  • University of California Irvine /ID# 259096Irvine, United StatesActive, not recruiting
  • Dermatology Research Associates /ID# 258033Los Angeles, United StatesRecruiting
  • Stanford University School of Medicine - Redwood City /ID# 259542Redwood City, United StatesCompleted
  • Integrative Skin Science and Research /ID# 258114Sacramento, United StatesRecruiting
  • University of California Davis Health /ID# 258112Sacramento, United StatesRecruiting
  • Clinical Trials Research Institute /ID# 258021Thousand Oaks, United StatesRecruiting
  • Skin Care Research Boca Raton /ID# 258012Boca Raton, United StatesRecruiting
  • Apex Clinical Trials /ID# 259205Brandon, United StatesActive, not recruiting
  • Florida Academic Dermatology Center /ID# 259353Coral Gables, United StatesActive, not recruiting
  • Skin Research Institute LLC /ID# 259207Coral Gables, United StatesCompleted
  • Revival Research /ID# 259213Doral, United StatesCompleted
  • Skin Care Research - Hollywood /ID# 259210Hollywood, United StatesRecruiting
  • GSI Clinical Research, LLC /ID# 259352Margate, United StatesRecruiting
  • Life Clinical Trials - N State Rd - Margate /ID# 259358Margate, United StatesActive, not recruiting
  • Lenus Research and Medical Group /ID# 259356Miami, United StatesRecruiting
  • International Clinical Research - Sanford /ID# 259547Sanford, United StatesCompleted
  • FWD Clinical Research /ID# 266687Tamarac, United StatesCompleted

And 258 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-505061-82-01
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)