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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 64 up to 96
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have lost more than 50% of my scalp hair for over 6 months, or almost all my hair.
Select...
I am able to have children and have a negative pregnancy test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 64 up to 96
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 64 up to 96
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the SALT score
Secondary outcome measures
Change in Alopecia Areata Physician's Global Assessment (aaPGA) scores
Change in Eyebrow Assessment Score
Change in Eyelash Assessment Score
+6 moreSide effects data
From 2021 Phase 4 trial • 188 Patients • NCT040333679%
Conjunctivitis
7%
Headache
3%
Dermatitis Atopic
2%
Nasopharyngitis
1%
Accidental Overdose
1%
Drug Hypersensitivity
1%
Polyarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
OLE Period: Placebo/Dupilumab
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Dupilumab/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
~12230
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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
617 Previous Clinical Trials
380,137 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have lost more than 50% of my scalp hair for over 6 months, or almost all my hair.I use a condom and an additional barrier method for contraception.I do not have active hepatitis B, C, or HIV.I have had alopecia areata with no hair regrowth for over 7 years.I have used creams for skin conditions within the last week.I do not have any severe ongoing health issues affecting my kidneys, liver, blood, metabolism, hormones, lungs, heart, or nervous system.I am able to have children and have a negative pregnancy test.I have been treated with dupilumab before.I have not received a live vaccine in the last 30 days.I am using or plan to use anti-retroviral therapy during the study.I have a high IgE level or a history of allergies in my family or myself.You have a weakened immune system, as determined by the doctor.My hair loss cause is unknown or due to multiple factors.I haven't taken any strong immune system suppressing drugs in the last 4 weeks.I have ongoing severe infections or a history of them.I have severe asthma that isn't controlled by medication.I haven't taken any JAK inhibitor medication in the last 12 weeks.I have or might have a blood cancer, or had any cancer except some skin and cervical cancers in the last 5 years.Your white blood cell count, platelet count, serum creatinine, liver enzymes, bilirubin, and hemoglobin levels are within specific ranges. You are in good health based on medical history, physical examination, and lab tests.
Research Study Groups:
This trial has the following groups:- Group 1: Dupilumab
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can patients anticipate any adverse effects from utilizing Dupilumab?
"Dupilumab was given a rating of 2 due to it being in Phase 2 trials and having some safety evidence but not any efficacy data."
Answered by AI
Are any participants being accepted for this experiment at the present moment?
"The data available on clinicaltrials.gov reveals that this medical trial, initially posted October 10th 2022, is no longer seeking participants. Nevertheless, 85 other trials are currently recruiting individuals for their studies."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I've been experiencing hair thinning and hair loss and I would like to act before it gets too late.
PatientReceived 1 prior treatment
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