Severe Alopecia AreataPhase 3NCT07772492
A Study to Evaluate the Safety and Effectiveness of Upadacitinib in Pediatric Participants With Alopecia Areata
A Phase 3 study testing Upadacitinib in people with Severe Alopecia Areata, run by AbbVie at 13 sites in 4 countries.
Trial summary
Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the scalp and face, but hair loss can happen on any hair-bearing part of the body. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Severe Alopecia Areata
- What is being tested?
- Upadacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 24 Aug 2026to Mar 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants must have a diagnosis of severe alopecia areata with SALT score >= 50 scalp hair loss at Screening and Baseline
- No spontaneous scalp hair regrowth over the past 6 months
- Participants will have current episode of alopecia areata of less than 8 years
Who cannot join
- Participants must not have a current diagnosis of primarily diffuse type of alopecia areata
- Participants must not have a diagnosis of other types of alopecia that would interfere with evaluation of alopecia areata, including but not limited to female pattern hair loss, male pattern hair loss (androgenetic alopecia) Stage III or greater, traction alopecia, lichen planopilaris, discoid lupus, frontal fibrosing alopecia, central centrifugal cicatricial alopecia, folliculitis decalvans, trichotillomania, and telogen effluvium
- Participants must not have a diagnosis of other types of inflammatory scalp, eyebrow, or eyelash disorders that would interfere with evaluation of alopecia areata, including but not limited to seborrheic dermatitis, scalp psoriasis, AD, and tinea capitis
Trial locations and contacts
13 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 4 countries
United States9 sites, 9 recruiting
- Recruiting
3A Research - East location /ID# 283404
El Paso, Texas, 79925
- Recruiting
Dermatologists of Southwestern Ohio (DSWO) /ID# 282818
Fairborn, Ohio, 45324
- Recruiting
Dawes Fretzin- Indianapolis /ID# 283498
Indianapolis, Indiana, 46250
- Recruiting
Dermatology Research Associates - Los Angeles /ID# 282821
Los Angeles, California, 90045
- Recruiting
Ada West Research /ID# 283063
Meridian, Idaho, 83646
- Recruiting
Pediatric Skin Research - Miami /ID# 283281
Miami, Florida, 33156
- Recruiting
Virginia Clinical Research /ID# 283797
Norfolk, Virginia, 23507
- Recruiting
Skin Specialists /ID# 283358
Omaha, Nebraska, 68144
- Recruiting
Texas Dermatology and Laser Specialists /ID# 282813
San Antonio, Texas, 78218
Australia2 sites, 2 recruiting
- Recruiting
Sinclair Dermatology - Melbourne /ID# 283854
East Melbourne, Victoria, 3002
- Recruiting
Premier Dermatology - Kogarah /ID# 283484
Kogarah, New South Wales, 2217
Japan1 site, 1 recruiting
- Recruiting
Shinsaibashi Inui Dermatology Clinic. /ID# 282706
Osaka, Osaka, 542-0081
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital /ID# 282900
Taipei, 112
About this study
Official title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study to Evaluate Efficacy and Safety of Upadacitinib in Pediatric Subjects With Severe Alopecia Areata
Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the scalp and face, but hair loss can happen on any hair-bearing part of the body. Some treatment options are available for adults and adolescents with AA, however there is still high unmet need for systemic treatments (treatment that moves throughout the bloodstream) approved for young patients with AA. Treatments may not work for all patients or may stop working over time. Because of this, researchers are developing new AA treatments, like upadacitinib. Upadacitinib is a type of medicine called a Janus- Kinase (JAK) inhibitor and works with the body to fight the inflammation that can cause AA. In this study, different doses (amounts) of upadacitinib are being compared to treatment with placebo (looks like the study treatment but contains no medicine).
Upadacitinib is an investigational JAK inhibitor being developed for the treatment of severe alopecia areata in pediatric patients. This is a randomized, double-blind, placebo-controlled study. Participants are placed in 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. Pediatric participants with a diagnosis of severe alopecia areata with SALT score ≥ 50 scalp hair loss will be enrolled. Participants will be at least 6 years old at Screening and less than 18 years old at Baseline. Approximately 300 participants will be enrolled in the study at approximately 120 sites worldwide.
Read more
Participants will receive oral doses of upadacitinib or matching placebo daily, or twice daily, for approximately 160 weeks. The study comprises a 35-day Screening Period, a 24-week placebo-controlled double-blinded treatment period (Period A), a 28-week blinded extension treatment period (Period B), a 108-week blinded long-term extension period (Period C), and a 30-day follow-up period.
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.
- Conditions
- Severe Alopecia Areata
- Being tested
- Upadacitinib, Placebo
- Keywords
- Alopecia Areata, Severe Alopecia Areata, Upadacitinib, ABT-494
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UpadacitinibDrug
Oral
PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Group 1A: Upadacitinib Dose 1 | Experimental | Participants will receive upadacitinib Dose 1 during Period A (Baseline to Week 24) and continue the same treatment through Period B (Week 24 to Week 52) and Period C (Week 52 to Week 160). Receives: Drug: Upadacitinib |
| Group 2A: Upadacitinib Dose 2 | Experimental | Participants will receive upadacitinib Dose 2 during Period A (Baseline to Week 24) and continue the same treatment through Period B (Week 24 to Week 52) and Period C (Week 52 to Week 160). Receives: Drug: Upadacitinib |
| Group 3A: Matching Placebo | Placebo comparator | Participants will receive matching placebo during Period A (Baseline to Week 24). Participants achieving SALT score ≤ 20 at Week 24 will remain on placebo until SALT score > 20, then switch to blinded upadacitinib. Participants with SALT score > 20 at Week 24 will be re-randomized to upadacitinib Dose 1 or Dose 2. Receives: Drug: Placebo |
| Group 1B: Upadacitinib Dose 1 | Experimental | Participants initially randomized to placebo in Period A with SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose 1 during Period B and continue through Period C. Receives: Drug: Upadacitinib |
| Group 2B: Upadacitinib Dose 2 | Experimental | Participants initially randomized to placebo in Period A with SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose 2 during Period B and continue through Period C. Receives: Drug: Upadacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20, defined as less than or equal to 20% scalp hair loss.
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%.
Measured: At 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.
Measured: Up to Week 160
Secondary outcomes (13)
Percentage of Participants Achieving 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%.
Measured: At Week 24
Percentage of Participants Achieving 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%.
Measured: At 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.
Measured: At Week 24
Percentage of Participants with the Achievement of Clinician-Reported Outcome (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.
Measured: At Week 24
Percentage of Participants Achieving 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%.
Measured: AT 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" (in participants who are 12 years and older at the time of baseline visit)
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."
Measured: At Week 24
Percentage of Participants with the Achievement of Patients' Caregiver Global Impression of Change (CaGIC-AA) Score of 1 "Much Better" or 2 "Moderately Better" (In Participants 6-11 Years Old at the time of baseline visit)
The CaGIC-AA is a single-item measure that asks care givers of 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."
Measured: At Week 24
Percentage of Participants with a Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score (In Participants 12 Years and Older)
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).
Measured: Baseline (Week 0) through Week 24
Percentage of Participants with a Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score
The CDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatological disease symptoms and treatment on quality of life. The CDLQI has been validated for use in Participants 4 to 16 years of age. It consists of 10 questions assessing impact of skin diseases on different aspects of quality of life over the prior week. The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item is scored on a 4-point scale: 0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) are added to provide a total score range of 0 to 30; higher scores indicate greater impairment of quality of life.
Measured: Baseline (Week 0) through Week 24
Percentage of Participants with a Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Depressive Symptoms Short Form 6a Score (In Participants 6-11 Years Old)
The PROMIS Parent Proxy Depressive Symptoms - SF6a is a caregiver report questionnaire designed to assess depressive symptoms in pediatric populations. It consists of 6 items that measure core aspects of mood, thoughts, and behaviors related to depression, as observed by the caregiver over the past 7 days. Caregivers are asked to rate each item using a 5-point Likert scale ranging from 'Never' to 'Almost Always'. Higher scores reflect greater severity of depressive symptoms.
Measured: Baseline (Week 0) through Week 24
Percentage of Participants with a Change From Baseline in PROMIS Pediatric Depressive Symptoms Short Form 8a Score (In Participants 12 Years and Older)
The PROMIS Pediatric Depressive Symptoms - SF8a is a self-report questionnaire designed to assess depressive symptoms in pediatric populations. It consists of 8 items focused on core aspects of mood, thoughts, and behaviors related to depression. Respondents rate each item based on their experiences over the past 7 days using a 5-point Likert scale ranging from 'Never' to 'Almost Always'. Higher scores indicate greater severity of depressive symptoms
Measured: Baseline (Week 0) through Week 24
Percentage of Participants with a Change From Baseline in PROMIS Parent Proxy Anxiety Short Form 8a Score (In Participants 6-11 Years Old)
The PROMIS Pediatric Anxiety - SF8a is a caregiver report questionnaire designed to assess anxiety symptoms in pediatric populations. It consists of 8 items that measure core aspects of worry, fear, and other anxiety-related feelings and behaviors as observed by the parent or caregiver. Each item item rated based on experiences over the past 7 days using a 5-point Likert scale ranging from 'Never' to 'Almost Always'. Higher scores reflect greater severity of anxiety symptoms
Measured: Baseline (Week 0) through Week 24
Percentage of Participants with a Change From Baseline in PROMIS Pediatric Anxiety Short Form 8a Score (In Participants 12 Years and Older)
The PROMIS Pediatric Anxiety - SF8a is a self-report questionnaire designed to assess anxiety symptoms in pediatric populations. It consists of 8 items that measure core aspects of worry, fear, and other anxiety-related feelings and behaviors. Respondents rate each item based on their experiences over the past 7 days using a 5-point Likert scale ranging from 'Never' to 'Almost Always'. Higher scores reflect greater severity of anxiety symptoms
Measured: Baseline (Week 0) through Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start24 Aug 2026
- Primary completionMar 2032 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Alopecia AreataStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772492
- Sponsor's protocol ID
- M24-725
- Other IDs
- 2025-525048-16-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 11 Aug 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Placebo-controlled, Double-blind Study to Evaluate Efficacy and Safety of Upadacitinib in Pediatric Subjects With Severe Alopecia Areata
- ClinicalTrials.gov ID
- NCT07772492
- Acronym / sponsor ID
- M24-725
- Conditions
- Severe Alopecia Areata
- Keywords
- Alopecia Areata, Severe Alopecia Areata, Upadacitinib, ABT-494
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2026 (actual)
- Primary completion
- Mar 2032 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the scalp and face, but hair loss can happen on any hair-bearing part of the body. Some treatment options are available for adults and adolescents with AA, however there is still high unmet need for systemic treatments (treatment that moves throughout the bloodstream) approved for young patients with AA. Treatments may not work for all patients or may stop working over time. Because of this, researchers are developing new AA treatments, like upadacitinib. Upadacitinib is a type of medicine called a Janus- Kinase (JAK) inhibitor and works with the body to fight the inflammation that can cause AA. In this study, different doses (amounts) of upadacitinib are being compared to treatment with placebo (looks like the study treatment but contains no medicine).
Upadacitinib is an investigational JAK inhibitor being developed for the treatment of severe alopecia areata in pediatric patients. This is a randomized, double-blind, placebo-controlled study. Participants are placed in 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. Pediatric participants with a diagnosis of severe alopecia areata with SALT score ≥ 50 scalp hair loss will be enrolled. Participants will be at least 6 years old at Screening and less than 18 years old at Baseline. Approximately 300 participants will be enrolled in the study at approximately 120 sites worldwide.
Participants will receive oral doses of upadacitinib or matching placebo daily, or twice daily, for approximately 160 weeks. The study comprises a 35-day Screening Period, a 24-week placebo-controlled double-blinded treatment period (Period A), a 28-week blinded extension treatment period (Period B), a 108-week blinded long-term extension period (Period C), and a 30-day follow-up period.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1A: Upadacitinib Dose 1 | Experimental | Drug: UpadacitinibParticipants will receive upadacitinib Dose 1 during Period A (Baseline to Week 24) and continue the same treatment through Period B (Week 24 to Week 52) and Period C (Week 52 to Week 160). |
| Group 2A: Upadacitinib Dose 2 | Experimental | Drug: UpadacitinibParticipants will receive upadacitinib Dose 2 during Period A (Baseline to Week 24) and continue the same treatment through Period B (Week 24 to Week 52) and Period C (Week 52 to Week 160). |
| Group 3A: Matching Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo during Period A (Baseline to Week 24). Participants achieving SALT score ≤ 20 at Week 24 will remain on placebo until SALT score > 20, then switch to blinded upadacitinib. Participants with SALT score > 20 at Week 24 will be re-randomized to upadacitinib Dose 1 or Dose 2. |
| Group 1B: Upadacitinib Dose 1 | Experimental | Drug: UpadacitinibParticipants initially randomized to placebo in Period A with SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose 1 during Period B and continue through Period C. |
| Group 2B: Upadacitinib Dose 2 | Experimental | Drug: UpadacitinibParticipants initially randomized to placebo in Period A with SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose 2 during Period B and continue through Period C. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Participants must have a diagnosis of severe alopecia areata with SALT score >= 50 scalp hair loss at Screening and Baseline
- No spontaneous scalp hair regrowth over the past 6 months
- Participants will have current episode of alopecia areata of less than 8 years
Key exclusion criteria (3 listed)
- Participants must not have a current diagnosis of primarily diffuse type of alopecia areata
- Participants must not have a diagnosis of other types of alopecia that would interfere with evaluation of alopecia areata, including but not limited to female pattern hair loss, male pattern hair loss (androgenetic alopecia) Stage III or greater, traction alopecia, lichen planopilaris, discoid lupus, frontal fibrosing alopecia, central centrifugal cicatricial alopecia, folliculitis decalvans, trichotillomania, and telogen effluvium
- Participants must not have a diagnosis of other types of inflammatory scalp, eyebrow, or eyelash disorders that would interfere with evaluation of alopecia areata, including but not limited to seborrheic dermatitis, scalp psoriasis, AD, and tinea capitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UpadacitinibOral | Drug | Group 1A: Upadacitinib Dose 1, Group 1B: Upadacitinib Dose 1, Group 2A: Upadacitinib Dose 2, Group 2B: Upadacitinib Dose 2 |
| PlaceboOral | Drug | Group 3A: Matching Placebo |
Primary outcome
Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20, defined as less than or equal to 20% scalp hair loss.
Time frame: At 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%.
Number of Participants with Adverse Events (AEs)
Time frame: Up to Week 160
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.
13 secondary outcomes
Percentage of Participants Achieving SALT Score <= 10
Time frame: At Week 24
Percentage of Participants Achieving SALT Score <= 20
Time frame: At Week 12
Percentage of Participants with the Achievement of Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss of 0 or 1
Time frame: At Week 24
Percentage of Participants with the Achievement of Clinician-Reported Outcome (ClinRO) Measure for Eyelash Hair Loss of 0 or 1
Time frame: At Week 24
Percentage of Participants Achieving SALT Score 0
Time frame: AT 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" (in participants who are 12 years and older at the time of baseline visit)
Time frame: At Week 24
Percentage of Participants with the Achievement of Patients' Caregiver Global Impression of Change (CaGIC-AA) Score of 1 "Much Better" or 2 "Moderately Better" (In Participants 6-11 Years Old at the time of baseline visit)
Time frame: At Week 24
Percentage of Participants with a Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score (In Participants 12 Years and Older)
Time frame: Baseline (Week 0) through Week 24
Percentage of Participants with a Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score
Time frame: Baseline (Week 0) through Week 24
Percentage of Participants with a Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Depressive Symptoms Short Form 6a Score (In Participants 6-11 Years Old)
Time frame: Baseline (Week 0) through Week 24
Percentage of Participants with a Change From Baseline in PROMIS Pediatric Depressive Symptoms Short Form 8a Score (In Participants 12 Years and Older)
Time frame: Baseline (Week 0) through Week 24
Percentage of Participants with a Change From Baseline in PROMIS Parent Proxy Anxiety Short Form 8a Score (In Participants 6-11 Years Old)
Time frame: Baseline (Week 0) through Week 24
Percentage of Participants with a Change From Baseline in PROMIS Pediatric Anxiety Short Form 8a Score (In Participants 12 Years and Older)
Time frame: Baseline (Week 0) through Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Upadacitinib in people with Severe Alopecia Areata, run by AbbVie at 13 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Australia, Japan, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20, defined as less than or equal to 20% scalp hair loss. (time frame: At Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.