NCT05866562 · Icahn School of Medicine at Mount Sinai
Dupilumab in the Treatment of Pediatric Alopecia Areata
(PEDAL)
What this study is about
This is a forward-looking, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment clinical trial. The study will take place at four sites.
View original scientific description
This is a prospective, randomized, double-blind, placebo-controlled clinical trial. The study will take place at four sites. This trial will enroll a total of 76 children and adolescents with moderate to severe AA (affecting at least 30% of the scalp) at the time of screening with a targeted 61 participants completing through Week 48.
Interventions
DRUG
Dupilumab
Participants weighing 15 kg \< 30 kg = 300 mg Every 4 Weeks; Participants weighing 30 kg \< 60 kg = 200 mg Every 2 Weeks; Participants weighing ≥ 60 kg = 300 mg Every 2 Weeks;
DRUG
Placebo
Participants weighing 15 kg \< 30 kg Every 4 Weeks; Participants weighing 30 kg \< 60 kg Every 2 Weeks; Participants weighing ≥ 60 kg Every 2 Weeks
Primary outcome measures
Change in the Severity of Alopecia Tool (SALT) score
Time frame: Baseline and Week 48
Change in the SALT score from baseline compared to Week 48 in Dupilumab treated vs placebo treated subjects. SALT score is the sum of percentage of hair loss in all areas (higher score indicates greater hair loss). The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time SALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas. SALT scores range from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating better health outcomes/less hair loss.
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
- Male or female participants who are at least 6 years old and under 18 years old, who can provide assent (if appropriate), and for whom signed informed consent can be provided by parent or legal guardian prior to participation in any study assessments or procedures \-- Participant is able to adhere to the study visit schedule and other protocol requirements.
- Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product (IP), FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:
- Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR
- Option 2: Male or female condom (latex
Where
- Irvine, California
- San Diego, California
- Chicago, Illinois
- New York, New York
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 Feb 20, 2026 · Source of record for eligibility and locations