Alopecia AreataPhase 2PEDALNCT05866562
Dupilumab in the Treatment of Pediatric Alopecia Areata
A Phase 2 study testing Dupilumab in people with Alopecia Areata, run by Icahn School of Medicine at Mount Sinai at 5 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 5 sitesUnited States
- Study dates
- 11 Jul 2024to 30 Apr 2029
- Phase
- Phase 2
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 condom or non-latex condom NOT made out of natural [animal] membrane [for example, polyurethane]);
- Participant has a history of at least 6 months of moderate to severe AA (≥ 50% scalp involvement) as measured using the SALT score.
- Participant has a screening IgE ≥ 200 and/or personal and/or familial history of atopy (including asthma, atopic dermatitis, allergic rhinitis, food allergy, or eosinophilic esophagitis)
- Participant is judged to be in otherwise good overall health following a detailed medical and medication history, physical examination, and laboratory testing.
Who cannot join
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Participant is pregnant or breastfeeding.
- Participant's cause of hair loss is indeterminable and/or they have concomitant causes of alopecia, such traction, cicatricial, pregnancy-related, drug-induced, telogen effluvium, or advanced androgenetic alopecia (i.e. Ludwig Type III or Norwood-Hamilton Stage ≥ V).
- Participant has a history of AA with no evidence of hair regrowth for ≥ 7 years since their last episode of hair loss.
- Severe, uncontrolled asthma (having 2 or exacerbations in the last 12 months that require systemic steroids and/or hospitalization) or a history of life-threatening asthma exacerbations while on appropriate anti-asthmatic medications.
- Participant has an active bacterial, viral, or helminth parasitic infections; OR a history of ongoing, recurrent severe infections requiring systemic antibiotics
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- Participant with a known or suspected underlying immunodeficiency or immune-compromised state as determined by the investigator.
- Participant has a concurrent or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, intestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease.
- Known active hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or positive HIV serology at the time of screening for subjects determined by the investigators to be at high-risk for this disease.
- Participant has a suspected or active lymphoproliferative disorder or malignancy; OR a history of malignancy within 5 years before the Baseline assessment, except for completely treated in situ non-melanoma skin and cervical cancers without evidence of metastasis.
- Participant has received a live attenuated vaccine ≤ 28 days prior to study randomization.
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
- History of adverse systemic or allergic reactions to any component of the study drug.
- Use of systemic immunosuppressive medications, including, but not limited to, cyclosporine, systemic or intralesional corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, tacrolimus, oral JAK inhibitor (tofacitinib, ruxolitinib, baricitinib, ritlecitinib, or investigational oral JAK Inhibitors) or ultraviolet (UV) phototherapy with/without Psoralen Ultraviolet A (PUVA) therapy, within 4 weeks prior to the Week 0/Baseline visit
- Participant has been previously treated with dupilumab
- Participant has used topical corticosteroids, and/or tacrolimus, and/or pimecrolimus within 1 week before the Baseline visit.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Brian Cheng, 312-503-5911, brian.cheng1@northwestern.edu
Amy Paller, MD, 312-227-6060, apaller@luriechildrens.org
- Recruiting
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Brian Cheng, 312-503-5911, brian.cheng1@northwestern.edu
Amy Paller, MD, 312-227-6060, apaller@nm.org
- Recruiting
University of California, Irvine
Irvine, California, 92697
Marcos Hurtado, 949-824-7103, marcosh3@hs.uci.edu
Jamy Paniagua, jamyp@hs.uci.edu
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Giselle Singer, 212-241-3288, giselle.singer@mssm.edu
Emma Guttman-Yassky, MD
- Recruiting
University of California San Diego
San Diego, California, 92093
Luis F Martinez, (619) 507-1182, LMartinez1@rchsd.org
About this study
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. All subjects must have evidence of hair regrowth within the last 7 years of their last episode of hair loss; and have screening IgE ≥200 and/or have personal and/or familial history of atopy.
Study participation will be up to 124 weeks, consisting of: a screening period of up to 4 weeks; a 48-week placebo-controlled period; a 48-week open-label extension period; followed by a 24-week follow-up period.
Read the detailed description
After providing consent, subjects will be assessed for study eligibility during the screening period (within 4 weeks of Baseline), which includes a review of past and current medical conditions, detailed review of past and current medications, a physical examination, clinical assessments, and laboratory tests for safety. Subjects who meet inclusion and exclusion criteria for eligibility will undergo Baseline assessments at Week 0. Subjects will return for visits every 8-16 weeks for repeat clinical assessments, medication reviews, and monitoring for adverse events. Female subjects will undergo a urine pregnancy test (where applicable) at each of these visits.
- Conditions
- Alopecia Areata
- Being tested
- Dupilumab, 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.
DupilumabDrug
Also called Dupixent
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;
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | Experimental | 200 mg or 300 mg SC injections every 2 or 4 weeks (weight based) Receives: Drug: Dupilumab |
| Placebo | Placebo comparator | Injections without active ingredients Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Severity of Alopecia Tool (SALT) score
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.
Measured: Baseline and Week 48
Secondary outcomes (12)
Proportion of participants achieving an absolute SALT score of ≤ 20 at Week 48 in dupilumab vs. placebo-treated participants
The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time. The scalp is 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). The percentage of hair loss in these areas is multiplied by the percent surface area of the scalp in that area. The SALT score is the sum of the percentage of hair loss in all areas. The SALT score ranges from 0 (no hair loss) to 100 (complete scalp hair loss), with a lower score indicating better health outcomes/less hair loss.
Measured: Baseline and Week 48
Change in SALT score in each treatment group at Weeks 48 and 96 compared to baseline
The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time. The scalp is 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). The percentage of hair loss in these areas is multiplied by the percent surface area of the scalp in that area. The SALT score is the sum of the percentage of hair loss in all areas. The SALT score ranges from 0 (no hair loss) to 100 (complete scalp hair loss), with a lower score indicating better health outcomes/less hair loss.
Measured: Baseline Week 48 and Week 96
Proportion of subjects achieving an absolute SALT score of ≤ 20 at Week 48 and Week 96 in each treatment group
The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time. The scalp is 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). The percentage of hair loss in these areas is multiplied by the percent surface area of the scalp in that area. The SALT score is the sum of the percentage of hair loss in all areas. The SALT score ranges from 0 (no hair loss) to 100 (complete scalp hair loss), with a lower score indicating better health outcomes/less hair loss.
Measured: Weeks 48 and 96
Proportion of participants achieving at least 30%/50%/75%/90% improvement (SALT 30/50/75/90) at Week 48 in dupilumab vs. placebo-treated participants
The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time. The scalp is 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). The percentage of hair loss in these areas is multiplied by the percent surface area of the scalp in that area. The SALT score is the sum of the percentage of hair loss in all areas. The SALT score ranges from 0 (no hair loss) to 100 (complete scalp hair loss), with a lower score indicating better health outcomes/less hair loss.
Measured: Week 48
Proportion of participants achieving at least 30%/50%/75%/90% improvement (SALT 30/50/75/90) at Weeks 48 and 96 in each treatment group
The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time. The scalp is 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). The percentage of hair loss in these areas is multiplied by the percent surface area of the scalp in that area. The SALT score is the sum of the percentage of hair loss in all areas. The SALT score ranges from 0 (no hair loss) to 100 (complete scalp hair loss), with a lower score indicating better health outcomes/less hair loss.
Measured: Weeks 48 and 96
Change in Alopecia Areata Symptom Impact Scale (AASIS) from Week 0/Baseline at Week 48 in dupilumab vs. placebo-treated participants
The AASIS is a 13-item, disease specific measure that asks patients with AA about the severity of their symptoms and how these symptoms interfere with their daily functioning. The AASIS uses a 0-10 numeric rating scale that patients find simple to understand and that is easily translated into different languages. AASIS scale 0-10: 0 indicates the symptom was not present and 10 indicates the symptom was as bad as one can imagine, where higher scores indicate worse symptoms.
Measured: Week 48
Change in Alopecia Areata Symptom Impact Scale (AASIS) from Week 0/Baseline at Weeks 48 and 96 in each treatment group
The AASIS is a 13-item, disease specific measure that asks patients with AA about the severity of their symptoms and how these symptoms interfere with their daily functioning. The AASIS uses a 0-10 numeric rating scale that patients find simple to understand and that is easily translated into different languages. AASIS scale 0-10: 0 indicates the symptom was not present and 10 indicates the symptom was as bad as one can imagine, where higher scores indicate worse symptoms.
Measured: Weeks 48 and 96
Patient's Global Impression of Change (PGIC) Scale score at Week 48 in dupilumab vs. placebo-treated subjects
PGIC is a self-administered questionnaire evaluating improvement or worsening of the participant's alopecia areata as compared to the start of the study and uses a single item, "Since the start of the study, my alopecia areata has…", with 7 responses ranging from 0 "no change or worse" to 7 "a great deal better" where higher scores indicate greater improvement.
Measured: Week 48
Patient's Global Impression of Change (PGIC) Scale score at Week 48 and 96 in each treatment group
PGIC is a self-administered questionnaire evaluating improvement or worsening of the participant's alopecia areata as compared to the start of the study and uses a single item, "Since the start of the study, my alopecia areata has…", with 7 responses ranging from 0 "no change or worse" to 7 "a great deal better" where higher scores indicate greater improvement.
Measured: Weeks 48 and 96
Proportion of subjects achieving Alopecia Areata Physician's Global Assessment (aaPGA) = 0-1 at Week 48 in dupilumab vs placebo-treated subjects
The proportion of alopecia areata subjects with aaPGA score of 0 or 1 at Week 48. The aaPGA is used to assess the clinical response to treatment based on a 6-point scale ranging from 0 (no regrowth) to 5 (100% regrowth), where higher scores indicate greater hair regrowth.
Measured: Week 48
Proportion of subjects achieving Alopecia Areata Physician's Global Assessment (aaPGA) = 0-1 at Week 48 and 96 in each treatment group
The proportion of alopecia areata subjects with aaPGA score of 0 or 1 at Week 48. The aaPGA is used to assess the clinical response to treatment based on a 6-point scale ranging from 0 (no regrowth) to 5 (100% regrowth), where higher scores indicate greater hair regrowth.
Measured: Weeks 48 and 96
Number of adverse events reported
Number of adverse events reported throughout the study. The adverse event will be described and categorized as treatment emergent, serious, abnormal in vital signs, and abnormal in lab parameters.
Measured: Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start11 Jul 2024
- Primary completion31 Mar 2029 (estimated)
- Study completion30 Apr 2029 (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.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emma Guttman, Icahn School of Medicine at Mount Sinai
- Investigators
- Emma Guttman-Yassky, MD, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866562
- Sponsor's protocol ID
- 23-00744
- Acronym
- PEDAL
- Status last verified
- Aug 2026
- First submitted
- 22 Feb 2023
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).