Regeneron AA Multicenter (Dupilumab)

NCT05551793 | Recruiting Phase 2 FDA Drug

• 1 other identifier: STUDY-22-01021
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 3

Brief Summary

This is a prospective, randomized, double blind, placebo-controlled clinical trial. The study will take place at 4 sites. This trial will enroll a total of 68 patients with moderate to severe AA (affecting more than 50% of the scalp) at the time of screening with a targeted 54 subjects completers through Week 48. AA 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. Subjects will be randomized (2:1) to either receive weekly dupilumab or placebo for 48 weeks, with all subjects completing participation through Week 48 receiving an additional 48 weeks of dupilumab (through Week 96).

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• Change in the SALT score

  Changes in the SALT score from baseline compared to week 48. SALT score is the sum of percentage of hair loss in all areas (higher score indicates greater hair loss). The change between baseline and Week 48 will be compared.

  Baseline and Week 48

Secondary Outcomes (10)

• Number of patients achieving an absolute SALT score of ≤ 20

  Week 48

• Number of patients achieving improvement in Severity of Alopecia Tool (SALT) score

  Weeks 16 up to 48

• Number of patients achieving improvement in Severity of Alopecia Tool (SALT) score

  Weeks 64 up to 96

• Change in the Alopecia Areata Symptom Impact Scale (AASIS)

  Baseline and Week 48

• Change in the Alopecia Areata Quality of Life questionnaire (AA-QoL)

  Baseline and Week 48

Study Arms (2)

Dupilumab

EXPERIMENTAL

Dupilumab: weekly 300mg SC injections Manufacturer: Regeneron

Drug: Dupilumab

Placebo

PLACEBO COMPARATOR

Placebo: weekly SC injections of equivalent volume Manufacturer: Regeneron

Drug: Placebo

Interventions

Dupilumab DRUG

Dupilumab: 300mg SC injections

Dupilumab

Placebo DRUG

Placebo: SC injections of equivalent volume

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects who are at least 18 years old at the time of informed consent.
• Subject is able to understand and voluntarily sign an informed consent document prior to participation in any study assessments or procedures.
• Subject 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 \[for example, polyurethane\]); PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
• If subject is a female of non-childbearing potential, she must have documented history of infertility, be in a menopausal state for one year, or had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy.
• Subject has a history of at least 6 months of moderate to severe AA (≥ 50% scalp involvement) as measured using the SALT score; OR subject has ≥ 95% loss of scalp hair for enrollment as AA totalis (AT) or universalis (AU) subtypes.
• Subject has a screening IgE \> 200 and/or personal and/or familial history of atopy.
• Subjects must meet the following laboratory criteria:
• White blood cell count ≥ 3000/mm3 (≥ 3.0 x 109/L) and \< 14,000/mm3 (≤ 14 x 109/L).
• Platelet count ≥ 100,000/μL (≥ 100 x 109/L).
• Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L).
• AST (SGOT) and ALT (SGPT) ≤ 2 x upper limit of normal (ULN). If the initial test shows ALT or AST \> 2 times the ULN, one repeat test is allowed during the Screening Phase.
• Total bilirubin ≤ 2 mg/dL (34 μmol/L). If the initial test shows total bilirubin \> 2 mg/dL (34 μmol/L), one repeat test is allowed during the Screening Phase.

You may not qualify if:

• The presence of any of the following will exclude a subject from enrollment:
• Subject is pregnant or breastfeeding.
• Subject'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).
• Subject has a history of AA with no evidence of hair regrowth for ≥ 7 years since their last episode of hair loss.
• Severe, uncontrolled asthma or a history of life-threatening asthma exacerbations while on appropriate anti-asthmatic mediations.
• Subject has an active bacterial, viral, or helminth parasitic infections; OR a history of ongoing, recurrent severe infections requiring systemic antibiotics
• Subject with a known or suspected underlying immunodeficiency or immune-compromised state as determined by the investigator.
• Subject has a concurrent or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, intestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease.
• Active hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or positive HIV serology or active or untreated latent tuberculosis at the time of screening for subjects determined by the investigators to be at high-risk for this disease.
• Subject 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.
• Subject has received a live attenuated vaccine ≤ 30 days prior to study randomization.
• Subject has any uncertain or clinically significant laboratory abnormalities that may affect interpretation of study data or endpoints.
• Subject has any other medical or psychological condition that, in the opinion of the investigator, may present additional unreasonable risks as a result of their participation in the study and/or interfere with clinic visits and necessary study assessments.
• History of adverse systemic or allergic reactions to any component of the study drug.
• Severe, untreated asthma or a history of life-threatening asthma exacerbations while on appropriate anti-asthmatic mediations.

Sponsors & Collaborators

• Emma Guttman: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (3)

University of California, Irvine

Irvine, California, 92697, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

UR Dermatology at College Town

Rochester, New York, 14620, 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

Giselle Singer

CONTACT

212-241-3288; giselle.singer@mssm.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sol and Clara Kest Professor and System Chair

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 23, 2022
• Study Start: April 10, 2023
• Primary Completion (Estimated): November 3, 2027
• Study Completion (Estimated): November 3, 2027
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)