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Monoclonal Antibodies
Dupilumab for Alopecia Areata
Phase 2
Waitlist Available
Led By Emma Guttman-Yassky, MD, PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline
Subject ≥ 30 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 96
Awards & highlights
Study Summary
This trial is testing whether a new medicine can help treat hair loss in children & teens with a history of atopy.
Who is the study for?
Children and teens aged 6-18 with moderate to severe Alopecia Areata (AA), affecting over half of the scalp, who weigh at least 30 kg. They must have had some hair regrowth in the past 7 years and either a personal or family history of allergies or related conditions. Participants need to be generally healthy, able to follow the study schedule, and girls able to bear children must test negative for pregnancy.Check my eligibility
What is being tested?
The trial is testing Dupilumab against a placebo in kids with AA. It's set up so neither doctors nor patients know who gets what treatment (double-blind). The study will last up to 116 weeks including screening, treatment phases, and follow-up. Patients are randomly chosen for either Dupilumab or placebo.See study design
What are the potential side effects?
While specific side effects aren't listed here, Dupilumab can commonly cause skin reactions where injected, eye issues like redness or itching, cold sores in your mouth or on your lips. Less common but more serious side effects may include allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to have children and have a negative pregnancy test.
Select...
I weigh at least 30 kilograms.
Select...
I have had severe hair loss covering more than half of my scalp for at least 6 months.
Select...
I have a high IgE level or a personal/family history of allergies or asthma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 96
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 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 Severity of Alopecia Tool (SALT) score
Secondary outcome measures
Change in SALT score in each treatment group at 48 compares to baseline
Change in SALT score in each treatment group at Week 96 compared to baseline
Change in the Alopecia Areata Symptom Impact Scale (AASIS) at Week 48 in dupilumab vs placebo-treated
+15 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
every other week 200 mg or 300 mg (weight-based) SC injections
Group II: PlaceboPlacebo Group1 Intervention
Tablets without active ingredients
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~12230
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
858 Previous Clinical Trials
524,210 Total Patients Enrolled
6 Trials studying Alopecia Areata
155 Patients Enrolled for Alopecia Areata
Emma Guttman-Yassky, MD, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
3 Previous Clinical Trials
138 Total Patients Enrolled
2 Trials studying Alopecia Areata
118 Patients Enrolled for Alopecia Areata
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am using or plan to use anti-retroviral therapy during the study.I have or might have a blood cancer, or had another cancer in the last 5 years, except for certain skin and cervical cancers.I am between 6 and 18 years old and have my parent's or guardian's consent to participate.I have ongoing severe infections or a history of them.I do not have any severe ongoing health issues affecting my kidneys, liver, blood, metabolism, hormones, lungs, heart, or nervous system.I haven't taken any JAK inhibitor medications in the last 12 weeks.I weigh at least 30 kilograms.I have had severe hair loss covering more than half of my scalp for at least 6 months.I haven't taken any strong immune system suppressing drugs in the last 4 weeks.I am in good health overall, as confirmed by recent medical exams and tests.I am able to have children and have a negative pregnancy test.My hair loss cause is unknown or due to multiple factors.I have not received a live vaccine in the last 30 days.I have severe asthma that isn't controlled by medication.You have a condition that weakens your immune system.I do not have active hepatitis B, C, or HIV.I have used creams for skin conditions within the last week.I have a high IgE level or a personal/family history of allergies or asthma.I have had alopecia areata with no hair regrowth for over 7 years.I have been treated with dupilumab for over 3 months.
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.
Does this experiment include participants of fifty years and older?
"The age range to enroll in this trial is 6-17, with 13 trials for minors and 60 for the elderly."
Answered by AI
What evidence exists to indicate the security of using Dupilumab?
"Dupilumab's safety profile was assessed to be 2 on the scale of 1-3 due to its Phase 2 status, which indicates that there is some evidence for its safety but none indicating efficacy."
Answered by AI
Does this clinical trial accept fresh participants?
"The clinical trial is seeking 76 individuals with alopecia areata aged between 6 and 17 years old in order to participate."
Answered by AI
Is recruitment for this experiment still ongoing?
"As per clinicaltrials.gov, this specific study is not currently accepting participants and has since been edited on May 10th 2023. However, there are 87 other trials actively recruiting patients that were posted after the March 1st 2024 date of its original post."
Answered by AI
How widely dispersed are the sites where this trial can be accessed?
"Patients can enroll for this research study at Yale University in New Haven, Connecticut; Northwestern University Feinberg School of Medicine in Chicago, Illinois; as well Icahn School of Medicine at Mount Sinai in New york City. Moreover, there are another 4 locations offering the same opportunity."
Answered by AI
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