Dupilumab in the Treatment of Pediatric Alopecia Areata

NCT05866562 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 23-00744
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 5

Brief 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 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.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline and Week 48

• Change in SALT score in each treatment group at Weeks 48 and 96 compared to baseline

  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

  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

  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

  Weeks 48 and 96

Study Arms (2)

Dupilumab

EXPERIMENTAL

200 mg or 300 mg SC injections every 2 or 4 weeks (weight based)

Drug: Dupilumab

Placebo

PLACEBO COMPARATOR

Injections without active ingredients

Drug: Placebo

Interventions

Dupilumab DRUG

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;

Also known as: Dupixent

Dupilumab

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (5)

University of California, Irvine

Irvine, California, 92697, United States

RECRUITING

University of California San Diego

San Diego, California, 92093, United States

RECRUITING

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Alopecia Areata

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Emma Guttman-Yassky, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Ungar, MD

CONTACT

212-241-3288; benjamin.ungar@mountsinai.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Waldman Professor and System Chair

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: May 19, 2023
• Study Start: July 11, 2024
• Primary Completion (Estimated): August 17, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Immediately after publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.

Locations

US (5)