Alopecia AreataPhase 3THRIVE-AAJPNCT07617597
Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Japanese Adults With Severe Alopecia Areata
A Phase 3 study testing Deuruxolitinib in people with Alopecia Areata, run by Sun Pharma Japan Limited at 18 sites in Japan.
Trial summary
This study evaluates the efficacy and safety of deuruxolitinib in Japanese Adults between 18 and 65 years of age who have 50% or greater scalp hair loss. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Deuruxolitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 18 sitesJapan
- Study dates
- 19 Jun 2026to Sep 2028
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent has been obtained.
- Japanese subjects with severe alopecia areata who are between 18 and 65 years of age, inclusive, at the time of informed consent.
- Definitive diagnosis of alopecia areata with a current episode of scalp hair loss lasting at least 6 months.
- SALT score of 50 or more at both Screening and Baseline.
Who cannot join
- Treatment with systemic immunosuppressive medications or agents, including Janus kinase inhibitors, within 4 months prior to randomization.
- Treatment with biologics within 6 months prior to Screening.
- Positive test results for hepatitis B virus, hepatitis C virus, or human immunodeficiency virus at Screening.
- History of active tuberculosis, a positive interferon gamma release assay at Screening, or evidence of tuberculosis-related lesions on chest radiography.
- Clinically significant hematologic abnormalities, hepatic impairment, or renal impairment at Screening.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
Japan18 sites, 17 recruiting
- Recruiting
Study Site 102
Asahikawa, 078-8510
Clinical Trial Office, +81-166-68-2262, JPS.clinicaltrial@sunpharma.com
- Recruiting
Study Site 117
Bunkyō City, 113-8431
Tachibana, +81-3-5802-1584, JPS.clinicaltrial@sunpharma.com
- Recruiting
Study Site 119
Ebina, 243-0432
IRB Promotion Department, EPLink Co., Ltd., +81-46-236-3115, JPS.clinicaltrial@sunpharma.com
- Recruiting
Study Site 101
Hamamatsu, 431-3192
Clinical Research Center, +81-53-435-2850, JPS.clinicaltrial@sunpharma.com
- Recruiting
Study Site 116
Ishikawa, 920-0293
Aikawa, +81-76-218-8346, JPS.clinicaltrial@sunpharma.com
- Recruiting
Study Site 112
Kitakyushu, 807-8556
Kitamura, +81-93-691-7503, JPS.clinicaltrial@sunpharma.com
- Recruiting
Study Site 118
Kōtoku, 136-0075
Uchino, +81-3-5632-3111, JPS.clinicaltrial@sunpharma.com
- Recruiting
Study Site 110
Kurashiki, 701-0192
Fukuda, +81-86-462-1401, JPS.clinicaltrial@sunpharma.com
- Recruiting
Study Site 113
Kurume, 830-0011
Nakashima, +81-942-31-7888, JPS.clinicaltrial@sunpharma.com
- Recruiting
Study Site 107
Kyoto, 606-8507
Clinical Research Promotion Dept. (CRC Unit), +81-75-751-3111, JPS.clinicaltrial@sunpharma.com
- Recruiting
Study Site 106
Mitaka-shi, 181-8611
Nakada, +81-422-47-5511, JPS.clinicaltrial@sunpharma.com
- Withdrawn
Study Site 114
Miyagi-gun, 981-0112
- Recruiting
Study Site 104
Niigata, 951-8520
Clinical Trial Office, Center for Clinical Research, +81-25-227-2436, JPS.clinicaltrial@sunpharma.com
- Recruiting
Study Site 109
Osaka, 542-0081
Medical System Research Institute Co., Ltd., +81-6-6484-5755, JPS.clinicaltrial@sunpharma.com
- Recruiting
Study Site 108
Osaka, 545-0051
Clinical Trial Office, Clinical Research and Innovation Center, +81-06-6645-2121, JPS.clinicaltrial@sunpharma.com
- Recruiting
Study Site 103
Sapporo, 060-8648
Hashimoto, +81-11-706-7061, JPS.clinicaltrial@sunpharma.com
- Recruiting
Study Site 105
Shinjuku-Ku, 160-0023
Nakayama, +81-3-3342-6111 ext. 3951, JPS.clinicaltrial@sunpharma.com
- Recruiting
Study Site 111
Ube, 755-8505
Clinical Research Center, Clinical Trial Office, +81-836-85-3030, JPS.clinicaltrial@sunpharma.com
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adult Patients With Severe Alopecia Areata With an Open-Label Extension Period
This study evaluates the efficacy and safety of deuruxolitinib in Japanese Adults between 18 and 65 years of age who have 50% or greater scalp hair loss.
Read the detailed description
The efficacy and safety of deuruxolitinib in adult subjects with severe alopecia areata will be evaluated in this study, beginning with a double-blind, randomized, placebo-controlled Treatment Period of 24 weeks. Subjects between 18 and 65 years of age having at least 50% hair loss as measured by SALT and meeting eligibility criteria will be randomized to deuruxolitinib or placebo treatment. In the Open-label Extension part of the study, all participants from the Treatment Period will receive deuruxolitinib for 52 weeks.
- Conditions
- Alopecia Areata
- Being tested
- Deuruxolitinib, Placebo
- Keywords
- alopecia areata, severe alopecia areata, hair loss, deuruxolitinib, JAK inhibitor
- Medical subject headings
- Alopecia Areata, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeuruxolitinibDrug
Deuruxolitinib will be dosed orally as tablets at a dose of 8 mg
PlaceboDrug
Also called Deuruxolitinib
Deuruxolitinib matching placebo will be dosed orally as tablets for up to 24 weeks and then deuruxolitinib will be dosed for up to 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Deuruxolitinib 8 mg | Experimental | Participants in this arm will receive deuruxolitinib 8 mg administered orally twice daily (BID) during the 24-week double-blind treatment period and continue to receive deuruxolitinib 8 mg administered orally BID up to 52 weeks Receives: Drug: Deuruxolitinib |
| Placebo | Placebo comparator | Participants in this arm will receive matching placebo administered orally BID during the 24-week double-blind treatment period and then receive deuruxolitinib 8 mg administered orally BID up to 52 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects achieving an absolute SALT score of 20 or less
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Measured: Week 24
Secondary outcomes (19)
Percentage of responders (defined as "satisfied" or "very satisfied") on the Satisfaction of Hair Patient Reported Outcome (SPRO) scale
SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. Higher scores indicate the greater hair dissatisfaction.
Measured: Week 24
Percentage of subjects achieving an absolute SALT score of 20 or less
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Measured: Weeks 12, 16, and 20
Relative change in SALT scores from baseline
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Measured: Weeks 4, 8, 12, 16, 20, and 24
Percentage of responders (defined as "much improved" or "very much improved") using the CGI-I
The CGI-I is a questionnaire that asks the clinician to evaluate the improvement or worsening of the participant's alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders will defined as participants with responses of 6 (much improved) or 7 (very much improved).
Measured: Weeks 12, 16, 20, and 24
Percentage of responders (defined as "much improved" or "very much improved") using the PGI-I
The PGI-I is a self-administered questionnaire that asks the participant to evaluate the improvement or worsening of their alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders will be defined as participants with responses of 6 (much improved) or 7 (very much improved).
Measured: Weeks 12, 16, 20, and 24
Change from baseline in CGI-S
The CGI-S is a questionnaire that asks the clinician to evaluate the symptom severity of the participant's alopecia areata at the time of assessment. The symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.
Measured: Weeks 12, 16, 20, and 24
Change from baseline in PGI-S
The PGI-S is a self-administered questionnaire that asks the participant to evaluate the symptom severity of their alopecia areata at the time of assessment. Symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.
Measured: Weeks 12, 16, 20, and 24
Percentage of subjects achieving at least a 75% relative reduction in SALT score from baseline
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Measured: Weeks 12 and 24
Percentage of subjects achieving at least a 90% relative reduction in SALT score from baseline
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Measured: Weeks 12 and 24
Change from baseline in the Eyebrow Clinician-Reported Outcome (ClinRO) score
The Clinician-Reported Outcome Measure of Eyebrow Hair is a clinician-rated scale that assesses the total eyebrow hair present, with scores ranging from 0 to 3. A score of 0 indicates full eyebrow coverage with no areas of hair loss, and a score of 3 indicates no notable eyebrow hair. Higher scores indicate worse outcomes (greater hair loss).
Measured: Weeks 12 and 24
Change from baseline in the Eyelash Clinician-Reported Outcome (ClinRO) score
The Clinician-Reported Outcome Measure of Eyelash Hair is a clinician-rated scale that assesses the total eyelash hair present, with scores ranging from 0 to 3. A score of 0 indicates that eyelashes form a continuous line along the eyelids on both eyes, and a score of 3 indicates no notable eyelashes. Higher scores indicate worse outcomes (greater hair loss).
Measured: Weeks 12 and 24
Percentage of responders (defined as "satisfied" or "very satisfied") on the Satisfaction of Hair Patient Reported Outcome (SPRO) scale
SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. Higher scores indicate the greater hair dissatisfaction.
Measured: Weeks 12, 16, and 20
Change from baseline in SPRO scale
SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. Higher scores indicate the greater hair dissatisfaction.
Measured: Weeks 12, 16, 20, and 24
Percentage of subjects achieving a 2-point or greater improvement from baseline in SPRO scale
SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. Higher scores indicate the greater hair dissatisfaction.
Measured: Weeks 12, 16, 20, and 24
Change from baseline on the individual items of the Quality of Hair Patient Reported Outcome (QPRO) scale
The QPRO questionnaire provides additional details on key attributes of hair and helps provide context to the SPRO response. The individual items of QPRO are: Satisfied thickness hair coverage; Satisfied evenness hair coverage; How satisfied with your eyebrows; How satisfied with your eyelashes, scored on a scale ranging from 1 to 5 where 1=very satisfied, 2=satisfied, 3=neither satisfied nor dissatisfied, 4=dissatisfied, 5=very dissatisfied. Higher scores indicate the greater dissatisfaction on hair quality. A negative change from baseline indicate the greater satisfaction on hair quality.
Measured: Weeks 12, 16, 20, and 24
Change from baseline in the depression scale of the Hospital Anxiety and Depression Scale (HADS)
HADS is a questionnaire designed to assess anxiety and depression symptoms which is completed by participants. The questionnaire is comprised of two separate scales with a total of 14 items: A 7-item scale related to anxiety and 7-item scale related to depression. Each item within both scales is scored using a 4-point scale, ranging from 0 to 3 and the total scores in each scale can range from 0 to 21. Separate scores were created for anxiety and depression. A score between 0-7 is considered normal, 8-10 is mild, 11-14 is moderate, and >14 is severe anxiety or depression. Higher scores indicate greater severity. A negative change from baseline indicates less severity.
Measured: Week 24
Change from baseline in the anxiety scale of the Hospital Anxiety and Depression Scale (HADS)
HADS is a questionnaire designed to assess anxiety and depression symptoms which is completed by participants. The questionnaire is comprised of two separate scales with a total of 14 items: A 7-item scale related to anxiety and 7-item scale related to depression. Each item within both scales is scored using a 4-point scale, ranging from 0 to 3 and the total scores in each scale can range from 0 to 21. Separate scores were created for anxiety and depression. A score between 0-7 is considered normal, 8-10 is mild, 11-14 is moderate, and >14 is severe anxiety or depression. Higher scores indicate greater severity. A negative change from baseline indicates less severity.
Measured: Week 24
Percentage of subjects achieving an absolute SALT score of 20 or less
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Measured: Weeks 4 and 8
Percentage of subjects achieving an absolute SALT score of 10 or less
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Measured: Weeks 4, 8, 12, 16, 20, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start19 Jun 2026
- Primary completionFeb 2028 (estimated)
- Study completionSep 2028 (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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Pharma Japan Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617597
- Sponsor's protocol ID
- CTP-543-25-01JP
- Other IDs
- jRCT2031260062
- Acronym
- THRIVE-AAJP
- Status last verified
- Oct 2026
- First submitted
- 22 May 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adult Patients With Severe Alopecia Areata With an Open-Label Extension Period
- ClinicalTrials.gov ID
- NCT07617597
- Acronym / sponsor ID
- THRIVE-AAJP / CTP-543-25-01JP
- Conditions
- Alopecia Areata
- Keywords
- alopecia areata, severe alopecia areata, hair loss, deuruxolitinib, JAK inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Sun Pharma Japan LimitedIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 1 Jun 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.
This study evaluates the efficacy and safety of deuruxolitinib in Japanese Adults between 18 and 65 years of age who have 50% or greater scalp hair loss.
Detailed description
The efficacy and safety of deuruxolitinib in adult subjects with severe alopecia areata will be evaluated in this study, beginning with a double-blind, randomized, placebo-controlled Treatment Period of 24 weeks. Subjects between 18 and 65 years of age having at least 50% hair loss as measured by SALT and meeting eligibility criteria will be randomized to deuruxolitinib or placebo treatment. In the Open-label Extension part of the study, all participants from the Treatment Period will receive deuruxolitinib for 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deuruxolitinib 8 mg | Experimental | Drug: DeuruxolitinibParticipants in this arm will receive deuruxolitinib 8 mg administered orally twice daily (BID) during the 24-week double-blind treatment period and continue to receive deuruxolitinib 8 mg administered orally BID up to 52 weeks |
| Placebo | Placebo comparator | Drug: PlaceboParticipants in this arm will receive matching placebo administered orally BID during the 24-week double-blind treatment period and then receive deuruxolitinib 8 mg administered orally BID up to 52 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent has been obtained.
- Japanese subjects with severe alopecia areata who are between 18 and 65 years of age, inclusive, at the time of informed consent.
- Definitive diagnosis of alopecia areata with a current episode of scalp hair loss lasting at least 6 months.
- SALT score of 50 or more at both Screening and Baseline.
Key exclusion criteria (5 listed)
- Treatment with systemic immunosuppressive medications or agents, including Janus kinase inhibitors, within 4 months prior to randomization.
- Treatment with biologics within 6 months prior to Screening.
- Positive test results for hepatitis B virus, hepatitis C virus, or human immunodeficiency virus at Screening.
- History of active tuberculosis, a positive interferon gamma release assay at Screening, or evidence of tuberculosis-related lesions on chest radiography.
- Clinically significant hematologic abnormalities, hepatic impairment, or renal impairment at Screening.
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 |
|---|---|---|
| DeuruxolitinibDeuruxolitinib will be dosed orally as tablets at a dose of 8 mg | Drug | Deuruxolitinib 8 mg |
| PlaceboAlso: DeuruxolitinibDeuruxolitinib matching placebo will be dosed orally as tablets for up to 24 weeks and then deuruxolitinib will be dosed for up to 52 weeks | Drug | Placebo |
Primary outcome
Percentage of subjects achieving an absolute SALT score of 20 or less
Time frame: Week 24
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
19 secondary outcomes
Percentage of responders (defined as "satisfied" or "very satisfied") on the Satisfaction of Hair Patient Reported Outcome (SPRO) scale
Time frame: Week 24
Percentage of subjects achieving an absolute SALT score of 20 or less
Time frame: Weeks 12, 16, and 20
Relative change in SALT scores from baseline
Time frame: Weeks 4, 8, 12, 16, 20, and 24
Percentage of responders (defined as "much improved" or "very much improved") using the CGI-I
Time frame: Weeks 12, 16, 20, and 24
Percentage of responders (defined as "much improved" or "very much improved") using the PGI-I
Time frame: Weeks 12, 16, 20, and 24
Change from baseline in CGI-S
Time frame: Weeks 12, 16, 20, and 24
Change from baseline in PGI-S
Time frame: Weeks 12, 16, 20, and 24
Percentage of subjects achieving at least a 75% relative reduction in SALT score from baseline
Time frame: Weeks 12 and 24
Percentage of subjects achieving at least a 90% relative reduction in SALT score from baseline
Time frame: Weeks 12 and 24
Change from baseline in the Eyebrow Clinician-Reported Outcome (ClinRO) score
Time frame: Weeks 12 and 24
Change from baseline in the Eyelash Clinician-Reported Outcome (ClinRO) score
Time frame: Weeks 12 and 24
Percentage of responders (defined as "satisfied" or "very satisfied") on the Satisfaction of Hair Patient Reported Outcome (SPRO) scale
Time frame: Weeks 12, 16, and 20
Change from baseline in SPRO scale
Time frame: Weeks 12, 16, 20, and 24
Percentage of subjects achieving a 2-point or greater improvement from baseline in SPRO scale
Time frame: Weeks 12, 16, 20, and 24
Change from baseline on the individual items of the Quality of Hair Patient Reported Outcome (QPRO) scale
Time frame: Weeks 12, 16, 20, and 24
Change from baseline in the depression scale of the Hospital Anxiety and Depression Scale (HADS)
Time frame: Week 24
Change from baseline in the anxiety scale of the Hospital Anxiety and Depression Scale (HADS)
Time frame: Week 24
Percentage of subjects achieving an absolute SALT score of 20 or less
Time frame: Weeks 4 and 8
Percentage of subjects achieving an absolute SALT score of 10 or less
Time frame: Weeks 4, 8, 12, 16, 20, and 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 Oct 2026.
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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.
18 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 Deuruxolitinib in people with Alopecia Areata, run by Sun Pharma Japan Limited at 18 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 4 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: looking for participants now, as of the sponsor's last update on 30 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 18 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects achieving an absolute SALT score of 20 or less (time frame: Week 24). 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 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.