NCT07133308 · Sun Pharmaceutical Industries, Inc.
Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescents With Severe Alopecia Areata
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Deuruxolitinib
Deuruxolitinib will be dosed orally as tablets at a dose of 8 mg
DRUG
Placebo
Deuruxolitinib matching placebo will be dosed orally as tablets
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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 so
Where
- Birmingham, Alabama
- Scottsdale, Arizona
- Bryant, Arkansas
- Bakersfield, California
- Fremont, California
- Los Angeles, California
- Palm Springs, California
- San Diego, California
- Denver, Colorado
- Wheat Ridge, Colorado
- Doral, Florida
- Hollywood, Florida
And 35 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 28, 2026 · Source of record for eligibility and locations