What side effects are associated with this type of intervention?

Common treatments for Alopecia Areata, particularly JAK inhibitors like tofacitinib and baricitinib, have shown promise but come with potential side effects. Tofacitinib can cause adverse effects such as diarrhea, liver enzyme elevation, pancreatitis, and bone marrow suppression. Baricitinib, another JAK inhibitor, may also lead to similar immune-related side effects. Additionally, other treatments like cyclosporine and methotrexate, which are sometimes used for refractory cases, can cause serious adverse effects including liver toxicity, bone marrow suppression, and increased risk of infections. Patients should discuss these potential risks with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved baricitinib, an oral Janus kinase (JAK) 1 and JAK 2 inhibitor, for the treatment of severe alopecia areata. Baricitinib has demonstrated efficacy in phase 3 trials, showing superiority over placebo in achieving significant hair regrowth. Other JAK inhibitors, such as tofacitinib and ritlecitinib, are also being studied for their potential benefits in treating alopecia areata, but baricitinib remains the primary FDA-approved JAK inhibitor for this condition.

What other types of research exist?

A promising novel alternative to JAK inhibitors for treating Alopecia Areata in 2024 is Dupilumab. This drug is currently being evaluated in a prospective, randomized, double-blind, placebo-controlled clinical trial for children and adolescents with moderate to severe AA. The trial aims to assess the efficacy and safety of Dupilumab, which has shown potential in promoting hair regrowth in patients with a history of atopy.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 48 and 96

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

Conjunctivitis

Headache

Dermatitis Atopic

Nasopharyngitis

Accidental Overdose

Drug Hypersensitivity

Polyarthritis

100%

80%

60%

40%

20%

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

0 / 11Eligibility criteria met

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.