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Monoclonal Antibodies

Dupilumab for Alopecia Areata (PEDAL Trial)

Phase 2
Recruiting
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
Must not have
Subject currently uses or plans to use anti-retroviral therapy at any time during the study
Subject has an active bacterial, viral, or helminth parasitic infections; OR a history of ongoing, recurrent severe infections requiring systemic antibiotics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 48 and 96

Summary

This trial tests a new treatment for children and adolescents with significant hair loss due to Alopecia Areata. The treatment likely helps the immune system stop attacking hair follicles, allowing hair to regrow. Oral tofacitinib has shown promising results in treating alopecia areata in children.

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.
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.
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 below
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I am able to have children and have a negative pregnancy test.
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I weigh at least 30 kilograms.
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I have had severe hair loss covering more than half of my scalp for at least 6 months.
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I have a high IgE level or a personal/family history of allergies or asthma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am using or plan to use anti-retroviral therapy during the study.
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I have ongoing severe infections or a history of them.
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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 haven't taken any JAK inhibitor medications in the last 12 weeks.
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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 severe asthma that isn't controlled by medication.
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I have been treated with dupilumab for over 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 48 and 96
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 48 and 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 Severity of Alopecia Tool (SALT) score
Secondary study objectives
Change in Alopecia Areata Symptom Impact Scale (AASIS) from Week 0/Baseline at Week 48 in dupilumab vs. placebo-treated participants
Change in Alopecia Areata Symptom Impact Scale (AASIS) from Week 0/Baseline at Weeks 48 and 96 in each treatment group
Change in SALT score in each treatment group at Weeks 48 and 96 compared to baseline
+9 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367
9%
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
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Placebo/Dupilumab
OLE Period: Dupilumab/Dupilumab

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DupilumabExperimental Treatment1 Intervention
200 mg or 300 mg SC injections every 2 or 4 weeks (weight based)
Group II: PlaceboPlacebo Group1 Intervention
Injections without active ingredients
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~11960

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Alopecia Areata is an autoimmune condition where the immune system attacks hair follicles, leading to hair loss. JAK inhibitors, such as tofacitinib and baricitinib, work by inhibiting Janus kinase enzymes, which play a crucial role in the immune response. By modulating these enzymes, JAK inhibitors can reduce inflammation and autoimmunity, promoting hair regrowth. Other treatments include corticosteroids, which suppress the immune system to reduce inflammation, and topical immunotherapies like DPCP and SADBE, which aim to redirect the immune response away from hair follicles. Understanding these mechanisms is vital for patients as it helps them grasp how these treatments can potentially restore hair growth by targeting the underlying immune dysfunction.

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
909 Previous Clinical Trials
542,067 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

Dupilumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05866562 — Phase 2
Alopecia Areata Research Study Groups: Dupilumab, Placebo
Alopecia Areata Clinical Trial 2023: Dupilumab Highlights & Side Effects. Trial Name: NCT05866562 — Phase 2
Dupilumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05866562 — Phase 2
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