Alopecia AreataPhase 3Jump Up AA JPNCT07023302
A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants in Japan With Alopecia Areata
A Phase 3 study testing Upadacitinib in people with Alopecia Areata, run by AbbVie at 15 sites in Japan.
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 head and face, but hair loss can happen on any part of the body. Read more about this study
- Who is it for?
- Ages 12 to 63 years
- Conditions the study is for
- 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
- 125 participants
- Where
- 15 sitesJapan
- Study dates
- 19 Jun 2025to Feb 2029
- 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 12 to 63 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participant is judged to be in good health as determined by the Principal Investigator, based upon the results of the Screening assessments and medical history.
- Diagnosis of severe alopecia areata (AA) with Severity of Alopecia Tool (SALT) score >= 25 (>= 25% scalp hair loss) at Screening and Baseline.
- Current episode of AA of less than 8 years.
Who cannot join
- 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.
- Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to the Baseline Visit.
- Chronic recurring infection and/or active viral infection that, based on the investigator's clinical assessment, makes the participant an unsuitable candidate for the study.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Japan15 sites
Nagomi Dermatology Clinic /ID# 275418
Ebina-shi, Kanagawa, 243-0432
Hamamatsu University Hospital /ID# 274639
Hamamatsu, Shizuoka, 431-3192
Kanazawa Medical University Hospital /ID# 275521
Kahoku-gun, Ishikawa-ken, 920-0265
Kurume University Hospital /ID# 275519
Kurume-shi, Fukuoka, 830-0011
Kyorin University Hospital /ID# 274882
Mitaka-shi, Tokyo, 181-8611
Rifu Dermatology Allergy Clinic /ID# 274875
Miyagi-gun, Miyagi, 981-0112
Nagoya City University Hospital /ID# 275409
Nagoya, Aichi-ken, 467-8602
Niigata University Medical and Dental Hospital /ID# 274775
Niigata, Niigata, 951-8520
Shinsaibashi Inui Dermatology Clinic. /ID# 274851
Osaka, Osaka, 542-0081
Osaka Metropolitan University Hospital /ID# 274956
Osaka, Osaka, 545-8586
Tohoku University Hospital /ID# 274931
Sendai, Miyagi, 980-8574
Tokyo Medical University Hospital /ID# 274844
Shinjuku-ku, Tokyo, 160-0023
Keio University Hospital /ID# 275640
Shinjuku-ku, Tokyo, 160-8582
Juntendo Tokyo Koto Geriatric Medical Center /ID# 275424
Tokyo, 136-0075
Yamaguchi University Hospital /ID# 274638
Ube, Yamaguchi, 755-8505
About this study
Official title: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Alopecia Areata and at Least 25% Scalp Hair Loss
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 in Japan with severe AA.
Upadacitinib is an approved drug being investigated for the treatment of AA. In Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. In Period B, participants originally randomized to a upadacitinib dose group in Period A will continue their same treatment in Period B. Participants originally randomized to Placebo in Period A will be re-randomized in 1 of 2 groups receiving upadacitinib. Participants who complete Period B can join Period C and will receive 1 of 2 doses of upadacitinib for up to 52 weeks based on their SALT score. Around 123 adolescent and adult participants with severe AA will be enrolled in the study at approximately 20 sites in Japan.
Read more
Participants will receive oral tablets of either upadacitinib or placebo once daily for up to 104 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 their 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.
- Conditions
- Alopecia Areata
- Being tested
- Upadacitinib, Upadacitinib Placebo
- Keywords
- Alopecia Areata, Upadacitinib, JUMP-UP, AA
- 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 Tablets
Upadacitinib PlaceboDrug
Oral Tablets
| Study group | Role | What they receive |
|---|---|---|
| Group 1A: Upadacitinib Dose A | Experimental | Participants will receive upadacitinib dose A once daily for 52 weeks in Period A and Period B. Receives: Drug: Upadacitinib |
| Group 2A: Upadacitinib Dose B | Experimental | Participants will receive upadacitinib dose B once daily for 52 weeks in Period A and Period B. Receives: Drug: Upadacitinib |
| Group 3A: Upadacitinib Placebo | Placebo comparator | Participants will receive upadacitinib placebo once daily for 24 weeks in Period A. Receives: Drug: Upadacitinib Placebo |
| Group 1B: Upadacitinib Dose A | Experimental | Participants initially randomized to placebo (Period A) will be re-randomized to receive upadacitinib dose A once daily for 28 weeks in Period B. Receives: Drug: Upadacitinib |
| Group 2B: Upadacitinib Dose B | Experimental | Participants initially randomized to placebo (Period A) will be re-randomized to receive upadacitinib dose B once daily for 28 weeks in Period B. Receives: Drug: Upadacitinib |
| Period C: Upadacitinib Dose A Remains Dose A | Experimental | For participants initially randomized to dose A in Periods A and B and participants initially randomized to placebo who switched to dose A in Period B: participants with a Severity of Alopecia Tool (SALT) score <= 10 at Week 52 (end of Period B) will remain on blinded upadacitinib dose A once daily in Period C for 52 weeks. Receives: Drug: Upadacitinib |
| Period C: Upadacitinib Dose A to Dose B | Experimental | For participants initially randomized to dose A in Periods A and B and participants initially randomized to placebo who switched to dose A in Period B: participants with a SALT score > 10 at Week 52 (end of Period B) will dose escalate to blinded upadacitinib dose B once daily in Period C for 52 weeks. Receives: Drug: Upadacitinib |
| Period C: Upadacitinib Dose B Non-Sustained Responders | Experimental | For participants initially randomized to dose B in Periods A and B and participants initially randomized to placebo who switched to dose B in Period B: participants with a SALT score > 10 at Week 40 or Week 52 will remain on blinded upadacitinib dose B once daily in Period C for 52 weeks. Receives: Drug: Upadacitinib |
| Period C: Upadacitinib Dose B Sustained Responders | Experimental | For participants initially randomized to dose B in Periods A and B and participants initially randomized to placebo who switched to dose B in Period B: participants with a SALT score <= 10 at Week 40 and Week 52 will receive blinded upadacitinib dose A once daily in Period C for 52 weeks. Receives: Drug: Upadacitinib |
| Period C: Open-Label Upadacitinib Dose B | Experimental | Participants with no improvement or worsening from Baseline in their SALT score at the Week 40 visit or any scheduled visit thereafter will receive open-label upadacitinib dose B once daily for 52 weeks. 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 <= 10
The SALT is a global alopecia areata (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%. A SALT score of <= 10 is defined as less than or equal to 10% hair loss.
Measured: 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 approximately 108 weeks
Secondary outcomes (2)
Percentage of Participants with the Achievement of Patient-Reported Outcome (PRO) for Scalp Hair Assessment of 0 or 1
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 >=2.
Measured: 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."
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2025
- Study start19 Jun 2025
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 125 participants (actual)
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
- NCT07023302
- Sponsor's protocol ID
- M24-600
- Acronym
- Jump Up AA JP
- Status last verified
- Jul 2026
- First submitted
- 10 Jun 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- 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 30 Jul 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 Adult and Adolescent Subjects With Alopecia Areata and at Least 25% Scalp Hair Loss
- ClinicalTrials.gov ID
- NCT07023302
- Acronym / sponsor ID
- Jump Up AA JP / M24-600
- Conditions
- Alopecia Areata
- Keywords
- Alopecia Areata, Upadacitinib, JUMP-UP, AA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 125 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 16 Jun 2025 (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 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 in Japan with severe AA.
Upadacitinib is an approved drug being investigated for the treatment of AA. In Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. In Period B, participants originally randomized to a upadacitinib dose group in Period A will continue their same treatment in Period B. Participants originally randomized to Placebo in Period A will be re-randomized in 1 of 2 groups receiving upadacitinib. Participants who complete Period B can join Period C and will receive 1 of 2 doses of upadacitinib for up to 52 weeks based on their SALT score. Around 123 adolescent and adult participants with severe AA will be enrolled in the study at approximately 20 sites in Japan.
Participants will receive oral tablets of either upadacitinib or placebo once daily for up to 104 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 their 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Group 1A: Upadacitinib Dose A | Experimental | Drug: UpadacitinibParticipants will receive upadacitinib dose A once daily for 52 weeks in Period A and Period B. |
| Group 2A: Upadacitinib Dose B | Experimental | Drug: UpadacitinibParticipants will receive upadacitinib dose B once daily for 52 weeks in Period A and Period B. |
| Group 3A: Upadacitinib Placebo | Placebo comparator | Drug: Upadacitinib PlaceboParticipants will receive upadacitinib placebo once daily for 24 weeks in Period A. |
| Group 1B: Upadacitinib Dose A | Experimental | Drug: UpadacitinibParticipants initially randomized to placebo (Period A) will be re-randomized to receive upadacitinib dose A once daily for 28 weeks in Period B. |
| Group 2B: Upadacitinib Dose B | Experimental | Drug: UpadacitinibParticipants initially randomized to placebo (Period A) will be re-randomized to receive upadacitinib dose B once daily for 28 weeks in Period B. |
| Period C: Upadacitinib Dose A Remains Dose A | Experimental | Drug: UpadacitinibFor participants initially randomized to dose A in Periods A and B and participants initially randomized to placebo who switched to dose A in Period B: participants with a Severity of Alopecia Tool (SALT) score <= 10 at Week 52 (end of Period B) will remain on blinded upadacitinib dose A once daily in Period C for 52 weeks. |
| Period C: Upadacitinib Dose A to Dose B | Experimental | Drug: UpadacitinibFor participants initially randomized to dose A in Periods A and B and participants initially randomized to placebo who switched to dose A in Period B: participants with a SALT score > 10 at Week 52 (end of Period B) will dose escalate to blinded upadacitinib dose B once daily in Period C for 52 weeks. |
| Period C: Upadacitinib Dose B Non-Sustained Responders | Experimental | Drug: UpadacitinibFor participants initially randomized to dose B in Periods A and B and participants initially randomized to placebo who switched to dose B in Period B: participants with a SALT score > 10 at Week 40 or Week 52 will remain on blinded upadacitinib dose B once daily in Period C for 52 weeks. |
| Period C: Upadacitinib Dose B Sustained Responders | Experimental | Drug: UpadacitinibFor participants initially randomized to dose B in Periods A and B and participants initially randomized to placebo who switched to dose B in Period B: participants with a SALT score <= 10 at Week 40 and Week 52 will receive blinded upadacitinib dose A once daily in Period C for 52 weeks. |
| Period C: Open-Label Upadacitinib Dose B | Experimental | Drug: UpadacitinibParticipants with no improvement or worsening from Baseline in their SALT score at the Week 40 visit or any scheduled visit thereafter will receive open-label upadacitinib dose B once daily for 52 weeks. |
Who may qualify
- Ages
- 12 to 63 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Participant is judged to be in good health as determined by the Principal Investigator, based upon the results of the Screening assessments and medical history.
- Diagnosis of severe alopecia areata (AA) with Severity of Alopecia Tool (SALT) score >= 25 (>= 25% scalp hair loss) at Screening and Baseline.
- Current episode of AA of less than 8 years.
Key exclusion criteria (5 listed)
- 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.
- Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to the Baseline Visit.
- Chronic recurring infection and/or active viral infection that, based on the investigator's clinical assessment, makes the participant an unsuitable candidate for the study.
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 Tablets | Drug | Group 1A: Upadacitinib Dose A, Group 1B: Upadacitinib Dose A, Group 2A: Upadacitinib Dose B, Group 2B: Upadacitinib Dose B, Period C: Open-Label Upadacitinib Dose B, Period C: Upadacitinib Dose A Remains Dose A, Period C: Upadacitinib Dose A to Dose B, Period C: Upadacitinib Dose B Non-Sustained Responders, Period C: Upadacitinib Dose B Sustained Responders |
| Upadacitinib PlaceboOral Tablets | Drug | Group 3A: Upadacitinib Placebo |
Primary outcome
Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 10
Time frame: Week 24
The SALT is a global alopecia areata (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%. A SALT score of <= 10 is defined as less than or equal to 10% hair loss.
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 108 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.
2 secondary outcomes
Percentage of Participants with the Achievement of Patient-Reported Outcome (PRO) for Scalp Hair Assessment of 0 or 1
Time frame: 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"
Time frame: 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 30 Jul 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. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
15 sites in 1 country: 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 Alopecia Areata, run by AbbVie at 15 sites in Japan.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Japan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 <= 10 (time frame: 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 30 Jul 2026.