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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031260062 | Registry Identifier | Japan Registry of Clinical Trials (jRCT) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deuruxolitinib | Drug | Deuruxolitinib will be dosed orally as tablets at a dose of 8 mg |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site 102 | Not yet recruiting | Asahikawa | 078-8510 | Japan | ||
| Study Site 117 |
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| 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 |
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| 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). | 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). | 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). | 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). | 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. | 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. | 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). | 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). | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | Weeks 4, 8, 12, 16, 20, and 24 |
| Not yet recruiting |
| Bunkyō City |
| 113-8431 |
| Japan |
| Study Site 119 | Not yet recruiting | Ebina | 243-0432 | Japan |
| Study Site 101 | Not yet recruiting | Hamamatsu | 431-3192 | Japan |
| Study Site 116 | Not yet recruiting | Ishikawa | 920-0293 | Japan |
| Study Site 112 | Not yet recruiting | Kitakyushu | 807-8556 | Japan |
| Study Site 118 | Not yet recruiting | Kōtoku | 136-0075 | Japan |
| Study Site 110 | Not yet recruiting | Kurashiki | 701-0192 | Japan |
| Study Site 113 | Not yet recruiting | Kurume | 830-0011 | Japan |
| Study Site 107 | Not yet recruiting | Kyoto | 606-8507 | Japan |
| Study Site 106 | Not yet recruiting | Mitaka-shi | 181-8611 | Japan |
| Study Site 114 | Not yet recruiting | Miyagi-gun | 981-0112 | Japan |
| Study Site 104 | Not yet recruiting | Niigata | 951-8520 | Japan |
| Study Site 109 | Recruiting | Osaka | 542-0081 | Japan |
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| Study Site 108 | Not yet recruiting | Osaka | 545-0051 | Japan |
| Study Site 103 | Not yet recruiting | Sapporo | 060-8648 | Japan |
| Study Site 105 | Not yet recruiting | Shinjuku-Ku | 160-0023 | Japan |
| Study Site 111 | Not yet recruiting | Ube | 755-8505 | Japan |
| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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