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CLINICAL STUDY · NCT06012240

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

RecruitingPhase 3Interventional

Sponsored by AbbVie

Condition
Alopecia Areata
Study locations
272 reported sites
Study updated
19 Oct 2026
Source
ClinicalTrials.gov

Overall study status is shown above. Individual hospitals may have a different recruitment status.

THE STUDY

About this study

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.
Full 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

PARTICIPATION

Who may participate

Minimum age
12 Years
Maximum age
63 Years
Sex eligibility
All sexes
Healthy volunteers
Not accepted

Only the study team can confirm eligibility. The registry criteria below are not a medical recommendation.

Full inclusion and exclusion criteria
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 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.

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.

NEAR YOU

Study locations worldwide

272 sites

Check the individual site’s status and contact the listed study team for current availability.

University of California Davis Health /ID# 258112

Recruiting

Sacramento, California, 95817, United States

Site contacts (1)
Site CoordinatorContactPhone: 916-551-2635

Skin Care Research Boca Raton /ID# 258012

Recruiting

Boca Raton, Florida, 33486-2269, United States

Site contacts (1)
Site CoordinatorContactPhone: +1-561-948-3116

Skin Care Research - Hollywood /ID# 259210

Recruiting

Hollywood, Florida, 33021-6748, United States

Site contacts (1)
Site CoordinatorContactPhone: +1-561-948-3116

Advanced Clinical Research Institute - Tampa /ID# 259204

Recruiting

Tampa, Florida, 33607, United States

Site contacts (1)
Site CoordinatorContactPhone: 1-813-362-1037

Tulane University School of Medicine /ID# 259799

Recruiting

New Orleans, Louisiana, 70112, United States

Site contacts (1)
Site CoordinatorContactPhone: 504-988-5135

Derm Institute of West Michigan /ID# 259546

Recruiting

Caledonia, Michigan, 49316-7478, United States

Site contacts (1)
Site CoordinatorContactPhone: 616-512-4445

Skin Specialists /ID# 259237

Recruiting

Omaha, Nebraska, 68144, United States

Site contacts (1)
Site CoordinatorContactPhone: 402-697-6599

Las Vegas Dermatology /ID# 279317

Recruiting

Las Vegas, Nevada, 89144, United States

Site contacts (1)
Site CoordinatorContactPhone: 702 456 3120

Skin Cancer and Dermatology Institute - Reno /ID# 259208

Recruiting

Reno, Nevada, 89509, United States

Site contacts (1)
Site CoordinatorContactPhone: 775-336-3665

Dermatologists of Southwest Ohio /ID# 260116

Recruiting

Mason, Ohio, 45040-4520, United States

Site contacts (1)
Site CoordinatorContactPhone: 513-701-5526

Advanced Dermatology And Cosmetic Surgery - Spartanburg /ID# 278359

Recruiting

Spartanburg, South Carolina, 29307, United States

Site contacts (1)
Site CoordinatorContactPhone: 864 574-0017 ext 8

U.S. Dermatology Partners - Cedar Park /ID# 259367

Recruiting

Cedar Park, Texas, 78613, United States

Site contacts (1)
Site CoordinatorContactPhone: 512-260-5860

Beijing Chaoyang Hospital,Capital Medical University /ID# 258912

Recruiting

Beijing, Beijing Municipality, 100020, China

Site contacts (1)
Site CoordinatorContactPhone: +86 010-85231777

Peking University People's Hospital /ID# 258940

Recruiting

Beijing, Beijing Municipality, 100044, China

Site contacts (1)
Site CoordinatorContactPhone: +86 010-88326666

Union Hospital - Tongji Medical College /ID# 266737

Recruiting

Wuhan, Hubei, 430022, China

Site contacts (1)
Site CoordinatorContactPhone: +86 027-85726114

Affiliated Dermatology Hospital of Shandong First Medical University /ID# 267520

Recruiting

Jinan, Shandong, 250022, China

Site contacts (1)
Site CoordinatorContactPhone: +86 0531-87298808

Universitaetsklinikum Muenster - Von-Esmarch-Strasse /ID# 257306

Recruiting

Münster, North Rhine-Westphalia, 48149, Germany

Site contacts (1)
Site CoordinatorContactPhone: +49 251 8356558

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 257310

Recruiting

Berlin, 10117, Germany

Site contacts (1)
Site CoordinatorContactPhone: +4930450518176

Medicover Integrated Clinical Services - Torun (SMO/Network/Consortium) /ID# 257740

Active, not recruiting

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

Study team contact · shared across sites

Email study team ↗View all study contacts ↓

Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 257537

Active, not recruiting

Elblag, Warmian-Masurian Voivodeship, 82-300, Poland

Study team contact · shared across sites

Email study team ↗View all study contacts ↓

WHAT IS BEING STUDIED

Treatments and study groups

Interventions

UpadacitinibDrug
Oral Tablets

Study groups: Study 1: Group 1 Upadacitinib Dose A, Study 1: Group 2 Upadacitinib Dose B, Study 1: Group 4 Upadacitinib Dose A, Study 1: Group 5 Upadacitinib Dose B, Study 2: Group 1 Upadacitinib Dose A, Study 2: Group 2 Upadacitinib Dose B, Study 2: Group 4 Upadacitinib Dose A, Study 2: Group 5 Upadacitinib Dose B, Study 3: Group 1 Upadacitinib Dose B (SALT > 20), Study 3: Group 2 Upadacitinib Dose A (SALT ≤ 20), Study 3: Group 3 Upadacitinib Dose B (Non-Sustained), Study 3: Group 4 Upadacitinib Dose B (Sustained), Study 3: Group 5 Upadacitinib Dose A (Sustained), Study 4: Group 1 Upadacitinib Dose A, Study 4: Group 2 Upadacitinib Dose B, Study 4: Group 4 Upadacitinib Dose A, Study 4: Group 5 Upadacitinib Dose B

Other names: Rinvoq, ABT-494

PlaceboDrug
Oral Tablets

Study groups: Study 1: Group 3 Placebo, Study 1: Group 4 Upadacitinib Dose A, Study 1: Group 5 Upadacitinib Dose B, Study 1: Group 6 Placebo, Study 2: Group 3 Placebo, Study 2: Group 4 Upadacitinib Dose A, Study 2: Group 5 Upadacitinib Dose B, Study 2: Group 6 Placebo, Study 4: Group 3 Placebo, Study 4: Group 6 Placebo

Study groups

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

Interventions: Drug: Upadacitinib

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

Interventions: Drug: Upadacitinib

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

Interventions: Drug: Placebo

Study 1: Group 4 Upadacitinib Dose AExperimental
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.

Interventions: Drug: Upadacitinib, Drug: Placebo

Study 1: Group 5 Upadacitinib Dose BExperimental
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.

Interventions: Drug: Upadacitinib, Drug: Placebo

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

Interventions: Drug: Placebo

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

Interventions: Drug: Upadacitinib

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

Interventions: Drug: Upadacitinib

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

Interventions: Drug: Placebo

Study 2: Group 4 Upadacitinib Dose AExperimental
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.

Interventions: Drug: Upadacitinib, Drug: Placebo

Study 2: Group 5 Upadacitinib Dose BExperimental
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.

Interventions: Drug: Upadacitinib, Drug: Placebo

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

Interventions: Drug: Placebo

Study 3: Group 1 Upadacitinib Dose B (SALT > 20)Experimental
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.

Interventions: Drug: Upadacitinib

Study 3: Group 2 Upadacitinib Dose A (SALT ≤ 20)Experimental
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.

Interventions: Drug: Upadacitinib

Study 3: Group 3 Upadacitinib Dose B (Non-Sustained)Experimental
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.

Interventions: Drug: Upadacitinib

Study 3: Group 4 Upadacitinib Dose B (Sustained)Experimental
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.

Interventions: Drug: Upadacitinib

Study 3: Group 5 Upadacitinib Dose A (Sustained)Experimental
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.

Interventions: Drug: Upadacitinib

Study 4: Group 1 Upadacitinib Dose AExperimental
US only adolescent participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.

Interventions: Drug: Upadacitinib

Study 4: Group 2 Upadacitinib Dose BExperimental
US only adolescent participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.

Interventions: Drug: Upadacitinib

Study 4: Group 3 PlaceboExperimental
US only adolescent participants will receive matching placebo once daily for 24 weeks in Period A.

Interventions: Drug: Placebo

Study 4: Group 4 Upadacitinib Dose AExperimental
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.

Interventions: Drug: Upadacitinib

Study 4: Group 5 Upadacitinib Dose BExperimental
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.

Interventions: Drug: Upadacitinib

Study 4: Group 6 PlaceboExperimental
Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160.

Interventions: Drug: Placebo

RESEARCH DETAILS

Study design

Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Study model
Sequential
Masking
Quadruple
Enrolment
1,500 participants · Estimated
Who is masked
Participant, Care provider, Investigator, Outcomes assessor

TIMELINE & MEASURES

Dates and outcomes

Study started
11 Oct 2023 · Actual
Primary completion
Apr 2030 · Estimated
Study completion
Apr 2030 · Estimated
First registered
25 Aug 2023 · Actual
Last registry update
19 Oct 2026 · Actual
Status last verified
Oct 2026
Primary outcomes (2)

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

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%.

Time frame: Week 24

Number of Participants with Adverse Events (AEs)

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.

Time frame: Up to approximately 164 weeks

Secondary outcomes (16)

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

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%.

Time frame: Week 24

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

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%.

Time frame: Up to Week 24

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

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%.

Time frame: Up to Week 12

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

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.

Time frame: Baseline to Week 24

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

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.

Time frame: Baseline to Week 24

Percentage of Participants with the Achievement of SALT 75

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

Time frame: Baseline to Week 24

Percentage of Participants with the Achievement of SALT 90

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

Time frame: Baseline to Week 24

Percent Change from Baseline in SALT Score

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%.

Time frame: Baseline to Week 24

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"

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."

Time frame: Up to Week 24

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

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.

Time frame: Baseline to Week 24

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

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.

Time frame: Week 24

Change from Baseline in AASIS Symptoms Subscale Score

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.

Time frame: Week 24

Change from Baseline in Skindex-16 AA Emotions Domain Scores

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.

Time frame: Week 24

Change from Baseline in Skindex-16 AA Functioning Domain Scores

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.

Time frame: Week 24

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

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).

Time frame: Baseline to Week 24

Percentage of Participants with the Achievement of SALT Score 0

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%.

Time frame: Week 24

STUDY TEAM

Sponsor and contacts

Lead sponsor
AbbVie
Sponsor type
Industry
Collaborators
Not reported
Organisation study ID
M23-716

Central study contacts

ABBVIE CALL CENTERContactPhone: 844-663-3742Email: abbvieclinicaltrials@abbvie.com
Study officials
ABBVIE INC.Study director · AbbVie

Contacts are provided by the registry for study enquiries. Do not use these details for marketing or promotions.

FURTHER READING

Results, documents and references

No results are posted in this registry record

This does not mean the study has no findings. Results may not yet have been submitted or published here.

No study documents are listed in this record.

Publications (1)
  1. Mostaghimi A, Gooderham MJ, Lynde C, Sinclair R, King B, Hordinsky M, Rudnicka L, Guttman-Yassky E, Serrao R, Ohyama M, Zhang X, Magnolo N, Kwon O, Oddi C, Meerwein S, Soliman AM, Bu X, Duan C, Wu T, Teixeira HD, Lazar A, Passeron T. Upadacitinib for Severe Alopecia Areata in Adults and Adolescents: Two Phase 3 UP-AA Randomized Clinical Trials. JAMA Dermatol. 2026 Aug 12:e262853. doi: 10.1001/jamadermatol.2026.2853. Online ahead of print. PubMed ↗

Source: ClinicalTrials.gov · Data fetched 20 Oct 2026, 15:51 GMT+0530

Registry data timestamp: 2026-10-19T09:00:04

Registry content is reformatted for readability; original study text is not rewritten. Missing information is labelled “Not reported”. Records are supplied by study sponsors or investigators and can change.

ClinicalTrials.gov does not endorse PharmaBharat. Listing a study does not mean it has been evaluated or approved by a government agency. Information is for research awareness and is not medical advice. Data source terms · Registry disclaimer

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