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This study evaluates the safety and effectiveness of deuruxolitinib in adolescents aged 12 to less than 18 years who have 50% or greater scalp hair loss.
The efficacy and safety of deuruxolitinib in adolescent 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 12 to <18 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, participants from the Treatment Period will receive deuruxolitinib for 52 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Period: Deuruxolitinib 8 mg | Experimental | Deuruxolitinib tablets, orally, twice daily (BID) for up to 24 weeks |
|
| Treatment Period: Placebo | Placebo Comparator | Deuruxolitinib-matched placebo tablets, orally, BID for up to 24 weeks |
|
| Open-Label Extension: Deuruxolitinib 8 mg BID | Experimental | Deuruxolitinib tablets, orally, BID for up to 52 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deuruxolitinib | Drug | Deuruxolitinib will be dosed orally as tablets at a dose of 8 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving an absolute Severity of Alopecia Tool (SALT) score ≤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). | Week 24 |
| Safety and tolerability of deuruxolitinib will be assessed by evaluating adverse events, vital signs, electrocardiograms, and clinical laboratory results, as well as physical examinations | Summary of participants who experience Treatment emergent adverse events (TEAEs) and serious TEAEs will be provided. An AE is defined as any untoward medical occurrence that may appear or worsen in a subject during the course of a study. Adverse events will be considered treatment-emergent if the onset is after the first dose of study drug. Summaries will be provided of participants who experience potentially clinically significant post-baseline changes in: hematology, chemistry and lipid results, vital signs (blood pressure, pulse rate, respiratory rate, temperature), electrocardiogram parameters (heart rate, PR, QT, QTcF, QRS, and RR) and physical examination findings. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving an absolute SALT score of ≤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). | Weeks 4, 8, 12, 16, and 20 |
| Mean percent change (ie, relative change) in SALT scores from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Head Regulatory Affairs | Contact | 9122 66455645 | Clinical.Trial@sunpharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin And Beauty Dermatology Center | Recruiting | Birmingham | Alabama | 35203 | United States | |
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Treatment period:
Model- Parallel Assignment, Number of Arms- 2
The Treatment period will be followed by the Open-Label Extension Period:
Model- Single Group Assignment, Number of Arms- 1
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All study subjects, Investigators, and site study staff will be blinded to study [Treatment Period] followed by None [Open-Label Extension]
| Placebo | Drug | Deuruxolitinib matching placebo will be dosed orally as tablets |
|
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 Clinical Global Impression of Improvement (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 Patient Global Impression of Improvement (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 |
| Mean change from baseline in the Clinical Global Impression of Severity (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 |
| Mean change from baseline in the Patient Global Impression of Severity (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 an absolute SALT score of ≤10 | 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 |
| Mean change from baseline on 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, based on a 4-point scale. | Weeks 4, 8, 12, 16, 20, and 24 |
| Mean change from baseline on 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, based on a 4-point scale | Weeks 4, 8, 12, 16, 20, 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 4, 8, 12, 16, 20, and 24 |
| Mean change from baseline in the 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. A negative change from baseline indicate the greater hair satisfaction. | Weeks 4, 8, 12, 16, 20, and 24 |
| Percentage of subjects achieving SALT score of ≤ 20 at Week 24 whose SPRO rating shifted from Very Dissatisfied or Dissatisfied to Very Satisfied or Satisfied | Week 24 |
| Percentage of subjects achieving SALT score of ≤ 10 at Week 24 whose SPRO rating shifted from Very dissatisfied or Dissatisfied to Very Satisfied or Satisfied | Week 24 |
| Mean 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 4, 8, 12, 16, 20 and 24 |
| Mean change from baseline in total score 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. | Weeks 12 and 24 |
| Mean change from baseline in the depression scale of the 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. | Weeks 12 and 24 |
| Mean change from baseline in the anxiety scale of the 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. | Weeks 12 and 24 |
| Percentage of subjects achieving a ≥ 6-point change from baseline in total score of the 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. | Weeks 12 and 24 |
| Percentage of subjects achieving a ≥ 3-point change from baseline in the depression scale of the 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. | Weeks 12 and 24 |
| Percentage of subjects achieving a ≥ 4-point change from baseline in the anxiety scale in total score of the 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. | Weeks 12 and 24 |
| Proportion of Participants with Suicidal Ideation or Behavior Per the Columbia-Suicide Severity Rating Scale (C-SSRS) | C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a "yes" answer to any of 5 suicidal behavior questions. Suicidal ideation is defined as a "yes" answer to either Questions 4 or 5 on the suicidal ideation section (with intent or plan). | Week 24 |
| Safety and tolerability of deuruxolitinib will be assessed by evaluating adverse events, vital signs, electrocardiograms, and clinical laboratory results, as well as physical examinations | Summary of participants who experience Treatment emergent adverse events (TEAEs) and serious TEAEs will be provided. An AE is defined as any untoward medical occurrence that may appear or worsen in a subject during the course of a study. Adverse events will be considered treatment-emergent if the onset is after the first dose of study drug. Summaries will be provided of participants who experience potentially clinically significant post-baseline changes in: hematology, chemistry and lipid results, vital signs (blood pressure, pulse rate, respiratory rate, temperature), electrocardiogram parameters (heart rate, PR, QT, QTcF, QRS, and RR) and physical examination findings. | Up to Week 80 |
| Effect of deuruxolitinib on treating Hair Loss as Measured by the Severity of Alopecia Tool (SALT) | Up to Week 76 |
| Avacare - Cct Research - Center For Dermatology And Plastic Surgery |
| Recruiting |
| Scottsdale |
| Arizona |
| 85260 |
| United States |
| Dermatology Trial Associates | Recruiting | Bryant | Arkansas | 72022 | United States |
| Kern Research Inc. | Recruiting | Bakersfield | California | 93301 | United States |
| Center For Dermatology Clinical Research Inc. | Recruiting | Fremont | California | 94538 | United States |
| Dermatology Research Associates | Recruiting | Los Angeles | California | 90045 | United States |
| Palmtree Clinical Research | Recruiting | Palm Springs | California | 92262 | United States |
| Paradigm Clinical Research - San Diego | Recruiting | San Diego | California | 92108 | United States |
| Colorado Medical Research Center | Recruiting | Denver | Colorado | 80210 | United States |
| Paradigm Clinical Research - Wheat Ridge | Recruiting | Wheat Ridge | Colorado | 80033 | United States |
| D&H Doral Research Center | Recruiting | Doral | Florida | 33122 | United States |
| Skin Care Research, Llc - Hollywood | Recruiting | Hollywood | Florida | 33021 | United States |
| Ilumina Medical Research Llc | Recruiting | Kissimmee | Florida | 34744 | United States |
| All X Ray Diagnostic Services Corp | Recruiting | Miami | Florida | 33126 | United States |
| Millennium Medical Research Llc | Recruiting | Miami | Florida | 33126 | United States |
| Florida International Medical Research | Recruiting | Miami | Florida | 33134 | United States |
| Florida Pharmaceutical Research And Associates, Inc. | Recruiting | Miami | Florida | 33143 | United States |
| L&C Professional Medical Research Institute | Recruiting | Miami | Florida | 33144 | United States |
| Pediatric Skin Research Llc | Recruiting | Miami | Florida | 33156 | United States |
| Valencia Medical & Research Center | Recruiting | Miami | Florida | 33174 | United States |
| Advance Research Center, Llc | Recruiting | Miami | Florida | 33183 | United States |
| Barroso Medical Services Llc | Recruiting | Miami Lakes | Florida | 33014 | United States |
| Nexus Research Llc | Recruiting | Pompano Beach | Florida | 33063 | United States |
| International Clinical Research Us Llc - Sanford | Recruiting | Sanford | Florida | 32771 | United States |
| Lenus Research & Medical Group Llc. | Recruiting | Sweetwater | Florida | 33172 | United States |
| Cleaver Medical Group Dermatology | Recruiting | Cumming | Georgia | 30040 | United States |
| Skin Care Physicians Of Georgia | Recruiting | Macon | Georgia | 31217 | United States |
| Georgia Skin & Cancer Clinic | Recruiting | Savannah | Georgia | 31419 | United States |
| Asr, Llc | Recruiting | Boise | Idaho | 83702 | United States |
| Denova Research | Recruiting | Chicago | Illinois | 60611 | United States |
| Ds Research - Indiana | Recruiting | Clarksville | Indiana | 47129 | United States |
| Dawes Fretzin Clinical Research Group Llc. | Recruiting | Indianapolis | Indiana | 46250 | United States |
| Ds Research - Kentucky | Recruiting | Louisville | Kentucky | 40241 | United States |
| U.S. Dermatology Partners - Rockville | Recruiting | Rockville | Maryland | 20850 | United States |
| Oakland Hills Dermatology | Recruiting | Auburn Hills | Michigan | 48326 | United States |
| Revival Research Institute, Llc - Troy, Mi | Recruiting | Troy | Michigan | 48084 | United States |
| Medisearch Clinical Trials | Recruiting | Saint Joseph | Missouri | 64506 | United States |
| Boeson Research Mso | Recruiting | Missoula | Montana | 59804 | United States |
| Skin Specialists, Pc | Recruiting | Omaha | Nebraska | 68144 | United States |
| Schweiger Dermatology & Allergy - Verona | Recruiting | Verona | New Jersey | 07044 | United States |
| Vitality Clinical Trials | Recruiting | Woodbury | New York | 11797 | United States |
| Revival Research Institute, Llc - Cary, Nc | Recruiting | Cary | North Carolina | 27511 | United States |
| Darst Dermatology | Recruiting | Charlotte | North Carolina | 28277 | United States |
| Dermatologists Of Southwest Ohio | Recruiting | Mason | Ohio | 45040 | United States |
| Dermatology Associates Of Plymouth Meeting | Recruiting | Plymouth Meeting | Pennsylvania | 19462 | United States |
| Tribe Clinical Research, Llc | Recruiting | Greenville | South Carolina | 29607 | United States |
| Delricht Research - Smyrna | Recruiting | Smyrna | Tennessee | 37167 | United States |
| Dermatology Treatment And Research Center - Dallas | Recruiting | Dallas | Texas | 75230 | United States |
| North Texas Center For Clinical Research | Recruiting | Frisco | Texas | 75034 | United States |
| Austin Institute For Clinical Research Inc. | Recruiting | Pflugerville | Texas | 78660 | United States |
| Texas Dermatology And Laser Specialists | Recruiting | San Antonio | Texas | 78218 | United States |
| Jordan Valley Dermatology | Recruiting | South Jordan | Utah | 84095 | United States |
| Avacare - Cct Research - Springville Dermatology | Recruiting | Springville | Utah | 84663 | United States |
| National Eagle Research, Llc | Recruiting | Lynnwood | Washington | 98036 | United States |
| Kirk Barber Research | Recruiting | Calgary | Alberta | T2G 1B1 | Canada |
| Dermatology Research Institute (Calgary) | Recruiting | Calgary | Alberta | T2J 7E1 | Canada |
| Alberta Dermasurgery Centre | Recruiting | Edmonton | Alberta | T6G 1C3 | Canada |
| Care Clinic Ltd. | Recruiting | Red Deer | Alberta | T4P 1K4 | Canada |
| Medical Arts Health Research Group - Kelowna | Recruiting | Kelowna | British Columbia | V1Y4N7 | Canada |
| Enverus Medical Research | Recruiting | Surrey | British Columbia | V3V 0C6 | Canada |
| Lynderm Research Inc. | Recruiting | Markham | Ontario | L3P 1X3 | Canada |
| Dr. S. K. Siddha Medicine Professional Corporation | Recruiting | Newmarket | Ontario | L3Y 5G8 | Canada |
| Research Toronto | Recruiting | Toronto | Ontario | M4W 2N4 | Canada |
| Facet Dermatology | Recruiting | Toronto | M4E 1R7 | Canada |
| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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