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Monoclonal Antibodies

Dupilumab for Alopecia Areata

Phase 2
Recruiting
Led By Emma Guttman-Yassky, MD, PhD
Research Sponsored by Emma Guttman
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline
Must not have
Subject has a history of AA with no evidence of hair regrowth for ≥ 7 years since their last episode of hair loss
Subject has a concurrent or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, intestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 64 up to 96

Summary

This trial is testing a new medication for people with a certain type of hair loss. The trial will last for 48 weeks and will enroll 68 people.

Who is the study for?
Adults with moderate to severe Alopecia Areata (AA) affecting more than half of the scalp, who have seen hair regrowth in the past 7 years and have a history or family history of allergies. Participants must be healthy overall, not pregnant or breastfeeding, use contraception if applicable, and meet specific blood test criteria. Excluded are those with certain diseases like hepatitis or HIV, recent immunosuppressive treatments, no AA hair regrowth for over 7 years, and other health risks.
What is being tested?
The trial is testing Dupilumab against a placebo in individuals with AA. It's randomized and double-blind meaning neither participants nor researchers know who gets what treatment. For 48 weeks some will get weekly Dupilumab injections while others get placebos; afterwards all receive Dupilumab for another 48 weeks.
What are the potential side effects?
While not specified here, common side effects of Dupilumab may include injection site reactions (redness or swelling), eye irritation or inflammation (pink eye), cold sores in your mouth or on your lips.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have lost more than 50% of my scalp hair for over 6 months, or almost all my hair.
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I am able to have children and have a negative pregnancy test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had alopecia areata with no hair regrowth for over 7 years.
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I do not have any severe ongoing health issues affecting my kidneys, liver, blood, metabolism, hormones, lungs, heart, or nervous system.
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I have been treated with dupilumab before.
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I am using or plan to use anti-retroviral therapy during the study.
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I haven't taken any strong immune system suppressing drugs in the last 4 weeks.
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I have ongoing severe infections or a history of them.
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I have severe asthma that isn't controlled by medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 64 up to 96
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 64 up to 96 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in the SALT score
Secondary study objectives
Change in Alopecia Areata Physician's Global Assessment (aaPGA) scores
Change in Eyebrow Assessment Score
Change in Eyelash Assessment Score
+6 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367
12%
Accidental Overdose
2%
Conjunctivitis
2%
Nasopharyngitis
2%
Headache
2%
Dermatitis Atopic
1%
Fall
1%
Multiple Fractures
100%
80%
60%
40%
20%
0%
Study treatment Arm
OLE Period: Dupilumab/Dupilumab
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Placebo/Dupilumab

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DupilumabExperimental Treatment1 Intervention
Dupilumab: weekly 300mg SC injections Manufacturer: Regeneron
Group II: PlaceboPlacebo Group1 Intervention
Placebo: weekly SC injections of equivalent volume Manufacturer: Regeneron
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~11960

Find a Location

Who is running the clinical trial?

Emma GuttmanLead Sponsor
3 Previous Clinical Trials
122 Total Patients Enrolled
3 Trials studying Alopecia Areata
122 Patients Enrolled for Alopecia Areata
Regeneron PharmaceuticalsIndustry Sponsor
671 Previous Clinical Trials
385,756 Total Patients Enrolled
1 Trials studying Alopecia Areata
60 Patients Enrolled for Alopecia Areata
Emma Guttman-Yassky, MD, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
3 Previous Clinical Trials
146 Total Patients Enrolled
2 Trials studying Alopecia Areata
126 Patients Enrolled for Alopecia Areata

Media Library

Dupilumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05551793 — Phase 2
Alopecia Areata Research Study Groups: Dupilumab, Placebo
Alopecia Areata Clinical Trial 2023: Dupilumab Highlights & Side Effects. Trial Name: NCT05551793 — Phase 2
Dupilumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05551793 — Phase 2
~36 spots leftby Dec 2026
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