Alopecia AreataPhase 3NCT07133308
Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescents With Severe Alopecia Areata
A Phase 3 study testing Deuruxolitinib in people with Alopecia Areata, run by Sun Pharmaceutical Industries, Inc. at 64 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 17 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
- 355 participants
- Where
- 64 sitesin 2 countries
- Study dates
- 5 Aug 2025to May 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical presentation compatible with alopecia areata with a current episode lasting at least 6 months and not exceeding 10 years.
- Between 12 to <18 years of age
- At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score ≥50.
- Willing to comply with the study visits and requirements of the study protocol
Who cannot join
- Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the SALT assessment, or untreated actinic keratosis at Screening and/or Baseline
- Treatment with other medications or agents within 28 days of Baseline or during the study that may affect hair regrowth or immune response.
- Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug.
- Clinically significant medical condition, psychiatric disease, or social condition, as determined by the Investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results.
Trial locations and contacts
64 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
64 sites in 2 countries
United States54 sites, 54 recruiting
- Recruiting
Oakland Hills Dermatology
Auburn Hills, Michigan, 48326
- Recruiting
Kern Research Inc.
Bakersfield, California, 93301
- Recruiting
Total Skin And Beauty Dermatology Center
Birmingham, Alabama, 35203
- Recruiting
Asr, Llc
Boise, Idaho, 83702
- Recruiting
Dermatology Trial Associates
Bryant, Arkansas, 72022
- Recruiting
Revival Research Institute, Llc - Cary, Nc
Cary, North Carolina, 27511
- Recruiting
Darst Dermatology
Charlotte, North Carolina, 28277
- Recruiting
Denova Research
Chicago, Illinois, 60611
- Recruiting
Ds Research - Indiana
Clarksville, Indiana, 47129
- Recruiting
Cleaver Medical Group Dermatology
Cumming, Georgia, 30040
- Recruiting
Dermatology Treatment And Research Center - Dallas
Dallas, Texas, 75230
- Recruiting
Colorado Medical Research Center
Denver, Colorado, 80210
- Recruiting
D&H Doral Research Center
Doral, Florida, 33122
- Recruiting
Center For Dermatology Clinical Research Inc.
Fremont, California, 94538
- Recruiting
North Texas Center For Clinical Research
Frisco, Texas, 75034
- Recruiting
Tribe Clinical Research, Llc
Greenville, South Carolina, 29607
- Recruiting
Skin Care Research, Llc - Hollywood
Hollywood, Florida, 33021
- Recruiting
Dawes Fretzin Clinical Research Group Llc.
Indianapolis, Indiana, 46250
- Recruiting
Ilumina Medical Research Llc
Kissimmee, Florida, 34744
- Recruiting
Dermatology Research Associates
Los Angeles, California, 90045
- Recruiting
Ds Research - Kentucky
Louisville, Kentucky, 40241
- Recruiting
National Eagle Research, Llc
Lynnwood, Washington, 98036
- Recruiting
Skin Care Physicians Of Georgia
Macon, Georgia, 31217
- Recruiting
Dermatologists Of Southwest Ohio
Mason, Ohio, 45040
- Recruiting
All X Ray Diagnostic Services Corp
Miami, Florida, 33126
- Recruiting
Millennium Medical Research Llc
Miami, Florida, 33126
- Recruiting
Florida International Medical Research
Miami, Florida, 33134
- Recruiting
Florida Pharmaceutical Research And Associates, Inc.
Miami, Florida, 33143
- Recruiting
L&C Professional Medical Research Institute
Miami, Florida, 33144
- Recruiting
Pediatric Skin Research Llc
Miami, Florida, 33156
- Recruiting
Valencia Medical & Research Center
Miami, Florida, 33174
- Recruiting
Advance Research Center, Llc
Miami, Florida, 33183
- Recruiting
Barroso Medical Services Llc
Miami Lakes, Florida, 33014
- Recruiting
Boeson Research Mso
Missoula, Montana, 59804
- Recruiting
Skin Specialists, Pc
Omaha, Nebraska, 68144
- Recruiting
Palmtree Clinical Research
Palm Springs, California, 92262
- Recruiting
Austin Institute For Clinical Research Inc.
Pflugerville, Texas, 78660
- Recruiting
Dermatology Associates Of Plymouth Meeting
Plymouth Meeting, Pennsylvania, 19462
- Recruiting
Nexus Research Llc
Pompano Beach, Florida, 33063
- Recruiting
U.S. Dermatology Partners - Rockville
Rockville, Maryland, 20850
- Recruiting
Medisearch Clinical Trials
Saint Joseph, Missouri, 64506
- Recruiting
Texas Dermatology And Laser Specialists
San Antonio, Texas, 78218
- Recruiting
Paradigm Clinical Research - San Diego
San Diego, California, 92108
- Recruiting
International Clinical Research Us Llc - Sanford
Sanford, Florida, 32771
- Recruiting
Georgia Skin & Cancer Clinic
Savannah, Georgia, 31419
- Recruiting
Avacare - Cct Research - Center For Dermatology And Plastic Surgery
Scottsdale, Arizona, 85260
- Recruiting
Delricht Research - Smyrna
Smyrna, Tennessee, 37167
- Recruiting
Jordan Valley Dermatology
South Jordan, Utah, 84095
- Recruiting
Avacare - Cct Research - Springville Dermatology
Springville, Utah, 84663
- Recruiting
Lenus Research & Medical Group Llc.
Sweetwater, Florida, 33172
- Recruiting
Revival Research Institute, Llc - Troy, Mi
Troy, Michigan, 48084
- Recruiting
Schweiger Dermatology & Allergy - Verona
Verona, New Jersey, 07044
- Recruiting
Paradigm Clinical Research - Wheat Ridge
Wheat Ridge, Colorado, 80033
- Recruiting
Vitality Clinical Trials
Woodbury, New York, 11797
Canada10 sites, 10 recruiting
- Recruiting
Kirk Barber Research
Calgary, Alberta, T2G 1B1
- Recruiting
Dermatology Research Institute (Calgary)
Calgary, Alberta, T2J 7E1
- Recruiting
Alberta Dermasurgery Centre
Edmonton, Alberta, T6G 1C3
- Recruiting
Medical Arts Health Research Group - Kelowna
Kelowna, British Columbia, V1Y4N7
- Recruiting
Lynderm Research Inc.
Markham, Ontario, L3P 1X3
- Recruiting
Dr. S. K. Siddha Medicine Professional Corporation
Newmarket, Ontario, L3Y 5G8
- Recruiting
Care Clinic Ltd.
Red Deer, Alberta, T4P 1K4
- Recruiting
Enverus Medical Research
Surrey, British Columbia, V3V 0C6
- Recruiting
Research Toronto
Toronto, Ontario, M4W 2N4
- Recruiting
Facet Dermatology
Toronto, M4E 1R7
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescent Patients With Severe Alopecia Areata With an Open-label Extension Period
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.
Read the detailed description
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.
- Conditions
- Alopecia Areata
- Being tested
- Deuruxolitinib, Placebo
- Medical subject headings
- Alopecia Areata
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
Deuruxolitinib matching placebo will be dosed orally as tablets
| Study group | Role | What they receive |
|---|---|---|
| Treatment Period: Deuruxolitinib 8 mg | Experimental | Deuruxolitinib tablets, orally, twice daily (BID) for up to 24 weeks Receives: Drug: Deuruxolitinib |
| Treatment Period: Placebo | Placebo comparator | Deuruxolitinib-matched placebo tablets, orally, BID for up to 24 weeks Receives: Drug: Placebo |
| Open-Label Extension: Deuruxolitinib 8 mg BID | Experimental | Deuruxolitinib tablets, orally, BID for up to 52 weeks Receives: Drug: Deuruxolitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Week 24
Secondary outcomes (23)
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).
Measured: Weeks 4, 8, 12, 16, and 20
Mean percent change (ie, 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 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Up to Week 80
Effect of deuruxolitinib on treating Hair Loss as Measured by the Severity of Alopecia Tool (SALT)
Measured: Up to Week 76
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start5 Aug 2025
- Primary completionMay 2028 (estimated)
- Study completionMay 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
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 355 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133308
- Sponsor's protocol ID
- CP543.3101
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescent Patients With Severe Alopecia Areata With an Open-label Extension Period
- ClinicalTrials.gov ID
- NCT07133308
- Acronym / sponsor ID
- CP543.3101
- Conditions
- Alopecia Areata
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 355 participants (estimated)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 21 Aug 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Treatment Period: Deuruxolitinib 8 mg | Experimental | Drug: DeuruxolitinibDeuruxolitinib tablets, orally, twice daily (BID) for up to 24 weeks |
| Treatment Period: Placebo | Placebo comparator | Drug: PlaceboDeuruxolitinib-matched placebo tablets, orally, BID for up to 24 weeks |
| Open-Label Extension: Deuruxolitinib 8 mg BID | Experimental | Drug: DeuruxolitinibDeuruxolitinib tablets, orally, BID for up to 52 weeks |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Clinical presentation compatible with alopecia areata with a current episode lasting at least 6 months and not exceeding 10 years.
- Between 12 to <18 years of age
- At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score ≥50.
- Willing to comply with the study visits and requirements of the study protocol
Key exclusion criteria (4 listed)
- Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the SALT assessment, or untreated actinic keratosis at Screening and/or Baseline
- Treatment with other medications or agents within 28 days of Baseline or during the study that may affect hair regrowth or immune response.
- Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug.
- Clinically significant medical condition, psychiatric disease, or social condition, as determined by the Investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results.
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 | Open-Label Extension: Deuruxolitinib 8 mg BID, Treatment Period: Deuruxolitinib 8 mg |
| PlaceboDeuruxolitinib matching placebo will be dosed orally as tablets | Drug | Treatment Period: Placebo |
Primary outcome
Percentage of subjects achieving an absolute Severity of Alopecia Tool (SALT) score ≤20
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).
Safety and tolerability of deuruxolitinib will be assessed by evaluating adverse events, vital signs, electrocardiograms, and clinical laboratory results, as well as physical examinations
Time frame: Week 24
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.
23 secondary outcomes
Percentage of subjects achieving an absolute SALT score of ≤20
Time frame: Weeks 4, 8, 12, 16, and 20
Mean percent change (ie, 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 Clinical Global Impression of Improvement (CGI-I)
Time frame: 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)
Time frame: Weeks 12, 16, 20, and 24
Mean change from baseline in the Clinical Global Impression of Severity (CGI-S)
Time frame: Weeks 12, 16, 20, and 24
Mean change from baseline in the Patient Global Impression of Severity (PGI-S)
Time frame: Weeks 12, 16, 20, and 24
Percentage of subjects achieving an absolute SALT score of ≤10
Time frame: Weeks 4, 8, 12, 16, 20, and 24
Mean change from baseline on the Eyebrow Clinician-Reported Outcome (ClinRO) score
Time frame: Weeks 4, 8, 12, 16, 20, and 24
Mean change from baseline on the Eyelash Clinician-Reported Outcome (ClinRO) score
Time frame: 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
Time frame: Weeks 4, 8, 12, 16, 20, and 24
Mean change from baseline in the SPRO scale
Time frame: 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
Time frame: 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
Time frame: Week 24
Mean change from baseline on the individual items of the Quality of Hair Patient Reported Outcome (QPRO) scale
Time frame: Weeks 4, 8, 12, 16, 20 and 24
Mean change from baseline in total score of the Hospital Anxiety and Depression Scale (HADS)
Time frame: Weeks 12 and 24
Mean change from baseline in the depression scale of the HADS
Time frame: Weeks 12 and 24
Mean change from baseline in the anxiety scale of the HADS
Time frame: Weeks 12 and 24
Percentage of subjects achieving a ≥ 6-point change from baseline in total score of the HADS
Time frame: Weeks 12 and 24
Percentage of subjects achieving a ≥ 3-point change from baseline in the depression scale of the HADS
Time frame: Weeks 12 and 24
Percentage of subjects achieving a ≥ 4-point change from baseline in the anxiety scale in total score of the HADS
Time frame: Weeks 12 and 24
Proportion of Participants with Suicidal Ideation or Behavior Per the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 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
Time frame: Up to Week 80
Effect of deuruxolitinib on treating Hair Loss as Measured by the Severity of Alopecia Tool (SALT)
Time frame: Up to Week 76
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 28 Jan 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.
64 sites in 2 countries: 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 Pharmaceutical Industries, Inc. at 64 sites in 2 countries.
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 4 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 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in United States, Canada. 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?
Contact Head Regulatory Affairs (9122 66455645, Clinical.Trial@sunpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects achieving an absolute Severity of Alopecia Tool (SALT) score ≤20 (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 28 Jan 2026.