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Dupilumab in the Treatment of Pediatric Alopecia Areata

Award Number: U01AI179629
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/15/2024
PERIOD OF PERFORMANCE END DATE: 04/30/2029

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Dupilumab in the Treatment of Pediatric Alopecia Areata - PROJECT SUMMARY/ABSTRACT Alopecia areata (AA) is a T cell–mediated, hair-specific disorder with a 2.1% lifetime risk, that recently has been also associated with Type 2 polarization and atopic comorbidities. 14%-25% of AA patients progress to alopecia totalis (AT) or even whole-body hair loss [alopecia universalis (AU)]. A large unmet need exists for efficacious and safer therapeutics for extensive AA patients (≥50% scalp loss), such as targeted therapeutic strategies that are now in use for other immune-mediated skin diseases such as atopic dermatitis (AD). This is particularly important in children, where treatments suitable for long-term use are not available. In a well-characterized clinical trial with 60 adult AA patients, we have recently showed that dupilumab, a monoclonal antibody that inhibits IL-4/IL-13 signaling by blocking the IL-4Rα subunit, induced significant hair regrowth, and significantly modulated the molecular AA phenotype in scalp tissues, particularly in patients with high IgE and/or atopic comorbidities, opening the door for targeted treatments for younger subjects with extensive AA. These data established a solid rationale for the potential of dupilumab to induce hair regrowth in pediatric AA patients with an atopic background. We hypothesize that the Th2 cytokines IL-4 and IL-13 are “drivers” in AA and their inhibition with dupilumab in pediatric AA subjects with an atopic background and/or high levels of IgE will shed light on the role of Type 2 inflammation in AA and the immune and regulatory pathways underlying suppression and/or induction of hair-associated keratins. We will test our hypothesis in a double-blinded clinical trial in 76 children (6-17 years old) with extensive AA (>/=50% scalp), randomized 2:1 to dupilumab or placebo, respectively, for 48 weeks, followed by another 48 weeks of open label dupilumab, and 16 weeks of follow-up (for a total of 112 weeks). We will test our hypothesis with the following specific aims (Aim 1 is related to clinical effects, while Aims 2 and 3 are translational aims): 1. To assess the safety, tolerability clinical efficacy, and durability of response with subcutaneous administration of dupilumab in pediatric subjects with severe (?50% scalp) AA and high IgE and/or atopic background; 2. To evaluate the ability of specific Th2 antagonism with dupilumab to modulate Th2 and other immune and regulatory pathways, as well as hair keratins, and stem cell biomarkers in scalp of children and adolescents with extensive AA; and 3. To characterize the ability of dupilumab to modulate inflammatory, regulatory, and tolerogenic immune pathways in blood of pediatric AA patients during and after treatment. By closely coupling biomarkers with clinical response, this trial will permit the maximal translational advantage. This study will expand our mechanistic understanding of AA in children and if successful, it may change the treatment paradigm for pediatric AA, enabling the use and further development of targeted therapeutics.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $1,309,584 )
2026	2026	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	1 GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Allergy and Infectious Diseases Research	001	3	5/4/2026	NON-COMPETING CONTINUATION	$1,309,584
2026	2025	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	1 GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Allergy and Infectious Diseases Research	000	2	2/11/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,309,584

Issue Date FY: 2025 ( Subtotal = $1,319,400 )
2025	2025	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	1 GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Allergy and Infectious Diseases Research	000	2	4/17/2025	NON-COMPETING CONTINUATION	$1,319,400
														Subtotal = $1,319,400

Issue Date FY: 2024 ( Subtotal = $1,419,216 )
2024	2024	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	1 GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Allergy and Infectious Diseases Research	000	1	5/15/2024	NEW	$1,419,216
														Subtotal = $1,419,216

Grand Total All Awards = $4,048,200

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Dupilumab in the Treatment of Pediatric Alopecia Areata

Award Number: U01AI179629

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/15/2024

PERIOD OF PERFORMANCE END DATE: 04/30/2029

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