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NCT Number: NCT07617597

Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Japanese Adults With Severe Alopecia Areata

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.

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Key information

Conditions

Alopecia Areata Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Study Site 102, Asahikawa, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Deuruxolitinib

Drug

Deuruxolitinib will be dosed orally as tablets at a dose of 8 mg

Placebo

Drug

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

Other names: Deuruxolitinib

Primary outcomes

  1. 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).

Secondary outcomes

  1. Percentage of responders (defined as "satisfied" or "very satisfied") on the Satisfaction of Hair Patient Reported Outcome (SPRO) scale

    Time frame: Week 24

    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.

  2. Percentage of subjects achieving an absolute SALT score of 20 or less

    Time frame: Weeks 12, 16, and 20

    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).

  3. Relative change in SALT scores from baseline

    Time frame: Weeks 4, 8, 12, 16, 20, and 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).

  4. Percentage of responders (defined as "much improved" or "very much improved") using the CGI-I

    Time frame: Weeks 12, 16, 20, and 24

    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).

  5. Percentage of responders (defined as "much improved" or "very much improved") using the PGI-I

    Time frame: Weeks 12, 16, 20, and 24

    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).

  6. Change from baseline in CGI-S

    Time frame: Weeks 12, 16, 20, and 24

    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.

  7. Change from baseline in PGI-S

    Time frame: Weeks 12, 16, 20, and 24

    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.

  8. Percentage of subjects achieving at least a 75% relative reduction in SALT score from baseline

    Time frame: Weeks 12 and 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).

  9. Percentage of subjects achieving at least a 90% relative reduction in SALT score from baseline

    Time frame: Weeks 12 and 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).

  10. Change from baseline in the Eyebrow Clinician-Reported Outcome (ClinRO) score

    Time frame: Weeks 12 and 24

    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).

  11. Change from baseline in the Eyelash Clinician-Reported Outcome (ClinRO) score

    Time frame: Weeks 12 and 24

    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).

  12. 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

    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.

  13. Change from baseline in SPRO scale

    Time frame: Weeks 12, 16, 20, and 24

    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.

  14. Percentage of subjects achieving a 2-point or greater improvement from baseline in SPRO scale

    Time frame: Weeks 12, 16, 20, and 24

    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.

  15. 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

    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.

  16. Change from baseline in the depression scale of the Hospital Anxiety and Depression Scale (HADS)

    Time frame: Week 24

    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.

  17. Change from baseline in the anxiety scale of the Hospital Anxiety and Depression Scale (HADS)

    Time frame: Week 24

    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.

  18. Percentage of subjects achieving an absolute SALT score of 20 or less

    Time frame: Weeks 4 and 8

    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. Percentage of subjects achieving an absolute SALT score of 10 or less

    Time frame: Weeks 4, 8, 12, 16, 20, and 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).

Sponsors and collaborators

Lead sponsor

Sun Pharma Japan Limited

Industry

Registry information

Official study 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

Acronym: THRIVE-AAJP

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 1, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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