Treatment of Alopecia Areata (AA) With Dupilumab in Patients With and Without Atopic Dermatitis (AD)

NCT03359356 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: GCO 17-1084
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Alopecia areata is a medical condition, in which the hair falls out in patches. The hair can fall out on the scalp or elsewhere on the face and body. Alopecia areata is an autoimmune skin disease, which means that the immune system is recognizing the hair follicles as foreign and attacking them, causing round patches of hair loss. It can progress to total scalp hair loss (alopecia totalis) or complete body hair loss (alopecia universalis). The scalp is the most commonly affected area, but the beard or any hair-bearing site can be affected alone or together with the scalp. Alopecia areata occurs in males and females of all ages, and is a highly unpredictable condition that tends to recur. Alopecia areata can cause significant distress to both patients and their families. In this study, the aim is to assess the effects of dupilumab in patients with alopecia areata.

Conditions

Alopecia Areata

Keywords

alopecia; alopecia areata; alopecia universalis; alopecia totalis; dupixent; dupilumab

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24

  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. Primary Outcome is baseline minus Week 24 value.

  Baseline and 24 weeks

Secondary Outcomes (10)

• Change From Week 24 in the SALT Score at Week 48

  Week 24 and 48 weeks

• Change From Baseline in the SALT Score at Week 48

  Baseline and 48 weeks

• Number of Patients Achieving at Least 50% Improvement in Severity of Alopecia Tool (SALT) Score (SALT-50) at Weeks 24 and 48 Compared to Baseline

  weeks 24 and 48

• Number of Patients Achieving at Least 75% Improvement in SALT-75 at Weeks 24 and 48

  Weeks 24 and 48

• Number of Patients Achieving at Least 90% Improvement in Severity of Alopecia Tool (SALT) Score (SALT-90) at Weeks 24 and 48

  Weeks 24 and 48

Study Arms (2)

Dupilumab

EXPERIMENTAL

An initial dupilumab dose of 600 mg (two 300 mg subcutaneous injections), followed by dupilumab 300 mg given every week

Drug: Dupilumab

Placebo

PLACEBO COMPARATOR

Matching placebo in prefilled syringes identical to the dupilumab syringes

Drug: Placebo

Interventions

Dupilumab DRUG

A total of 24 doses

Also known as: Dupixent

Dupilumab

Placebo DRUG

A total of 24 doses

Also known as: matching placebo

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
• 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 (≥ 30% 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.
• AT and AU will be limited to 50% of the total number of subjects enrolled.
• One-third of subjects must have active AD skin or a concomitant history of AD at the time of the Screening and Baseline visits.
• Subject has a negative Tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) prior to baseline. Subjects with a positive or indeterminable PPD or QFT result must have a documented negative workup for tuberculosis and/or completed standard tuberculosis therapy.
• 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).

You may not qualify if:

• 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 ≥ 10 years since their last episode of hair loss.
• 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 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.
• Use of systemic immunosuppressive medications, including, but not limited to, cyclosporine, systemic or intralesional corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, tacrolimus, or ultraviolet (UV) phototherapy with/without Psoralen Ultraviolet A (PUVA) therapy within 4 weeks prior to randomization.
• Use of an oral JAK inhibitor (tofacitinib, ruxolitinib) within 12 weeks prior to the Baseline visit.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Rockefeller University: collaborator
• Regeneron Pharmaceuticals: collaborator
• Sanofi: collaborator

Study Sites (2)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

The Rockefeller University Laboratory for Investigative Dermatology

New York, New York, 10065-6399, United States

Location

Related Publications (1)

• Guttman-Yassky E, Renert-Yuval Y, Bares J, Chima M, Hawkes JE, Gilleaudeau P, Sullivan-Whalen M, Singer GK, Garcet S, Pavel AB, Lebwohl MG, Krueger JG. Phase 2a randomized clinical trial of dupilumab (anti-IL-4Ralpha) for alopecia areata patients. Allergy. 2022 Mar;77(3):897-906. doi: 10.1111/all.15071. Epub 2021 Sep 6.

  PMID: 34460948 DERIVED

MeSH Terms

Conditions

Alopecia Areata; Alopecia; Alopecia universalis

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Emma Guttman
• Organization: Icahn School of Medicine at Mount Sinai

emma.guttman@mountsinai.org

212-241-9728

Study Officials

• Emma Guttman, MD,PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 2, 2017
• Study Start: January 9, 2018
• Primary Completion: January 14, 2020
• Study Completion: December 17, 2020
• Last Updated: September 13, 2022
• Results First Posted: February 14, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)