What side effects are associated with this type of intervention?

Common treatments for Alopecia Areata, particularly those involving immunosuppressive and immunomodulatory agents, have various side effects. Tofacitinib, a JAK inhibitor, can cause diarrhea, liver enzyme elevation, pancreatitis, and bone marrow suppression. Dupilumab, a biologic, has been associated with nasopharyngitis, headache, and in some cases, exacerbation of alopecia areata. Cyclosporine, another immunosuppressant, can lead to serious adverse effects such as nephrotoxicity, hypertension, and increased risk of infections, which often preclude its long-term use.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically targeting plasmacytoid dendritic cells for Alopecia Areata. However, other treatments such as tofacitinib, a Janus kinase inhibitor, have shown promise in clinical studies. Additionally, dupilumab, an IL-4/IL-13 inhibitor, has been studied for its potential benefits in treating Alopecia Areata, though it is not yet FDA-approved for this indication. These treatments represent ongoing efforts to find effective therapies for Alopecia Areata.

What other types of research exist?

Promising novel alternatives to Daxdilimab for Alopecia Areata patients include JAK inhibitors such as baricitinib and ruxolitinib, which have shown significant efficacy in clinical trials. Additionally, other monoclonal antibodies like dupilumab, which targets IL-4 and IL-13, are being explored for their potential benefits in treating AA. These treatments represent the forefront of therapeutic options expected to be available in 2024.

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Monoclonal Antibodies

Daxdilimab for Alopecia Areata

Phase 2

Waitlist Available

Research Sponsored by Amgen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests Daxdilimab, an injectable medication, in people with significant hair loss from Alopecia Areata. The goal is to see if it can safely reduce hair loss by changing how the immune system reacts.

Who is the study for?

This trial is for adults aged 18-65 with moderate-to-severe alopecia areata, having experienced significant hair loss (50-95%) without regrowth for the past 6 months to less than 7 years. Participants must be willing to maintain their current hairstyle and color throughout the study.

What is being tested?

The trial is testing Daxdilimab's effectiveness and safety in individuals with alopecia areata. It will evaluate how well it works, its tolerability, how the body processes it (pharmacokinetics), and how it affects the body's response (pharmacodynamics).

What are the potential side effects?

While specific side effects of Daxdilimab aren't listed here, similar treatments may cause reactions at injection sites, headaches, nausea, or potential immune system-related issues such as increased risk of infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: DaxdilimabExperimental Treatment1 Intervention

Nine sets of Daxdilimab injections over a total of 32 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daxdilimab

Not yet FDA approved

Do I qualify?Apply below to find out

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. Treatments often aim to modulate the immune response. Daxdilimab, a monoclonal antibody targeting plasmacytoid dendritic cells, works by reducing the activity of these cells, which are involved in the autoimmune response. Similarly, JAK inhibitors like tofacitinib block specific pathways that contribute to inflammation and immune activity. Corticosteroids suppress overall immune function, reducing inflammation around hair follicles. Immunosuppressants like methotrexate and cyclosporine also dampen the immune response. These treatments are crucial as they help in reducing the autoimmune attack on hair follicles, potentially leading to hair regrowth and improved quality of life for patients.