What side effects are associated with this type of intervention?

Common treatments for Atopic Dermatitis (AD) include monoclonal antibodies like dupilumab, JAK inhibitors like upadacitinib, and topical corticosteroids. Dupilumab, which targets IL-4 and IL-13, can cause side effects such as conjunctivitis, injection site reactions, and nasopharyngitis. Upadacitinib, an oral JAK inhibitor, may lead to acne, upper respiratory infections, headache, and elevated creatine phosphokinase levels. Topical corticosteroids, while effective, can cause skin thinning, stretch marks, and increased risk of skin infections with prolonged use. Lirentelimab (AK002), an anti-Siglec-8 monoclonal antibody, is being studied for its efficacy and safety, with potential side effects including local skin reactions and mild-to-moderate anaphylaxis.

What prior FDA approvals exist?

The FDA has approved several biologics for the treatment of Atopic Dermatitis. Dupilumab, a fully human monoclonal antibody that inhibits IL-4 and IL-13 signaling, was one of the first biologics approved for moderate-to-severe AD. It targets the Th2 pathway, which is crucial in the pathogenesis of AD. Another example is Tralokinumab, an anti-IL-13 monoclonal antibody, which has also been approved for moderate-to-severe AD. These treatments, like Lirentelimab (AK002), aim to modulate the immune response, although they target different cytokines and cells involved in the inflammatory process of AD.

What other types of research exist?

Promising novel alternatives to Lirentelimab (AK002) for Atopic Dermatitis patients include: 1) Dupilumab, a monoclonal antibody targeting IL-4 and IL-13, which has shown significant efficacy in AD. 2) Upadacitinib, an oral Janus kinase (JAK) inhibitor, which has demonstrated positive results in clinical trials for moderate-to-severe AD. 3) Abrocitinib, another JAK inhibitor, which has also shown promising results in clinical trials for AD. These therapies target different pathways involved in the inflammatory process of AD and offer new options for patients inadequately controlled by existing treatments.

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Monoclonal Antibodies

AK002 for Atopic Dermatitis (ATLAS Trial)

Phase 2

Waitlist Available

Research Sponsored by Allakos, Inc.

Eligibility Criteria Checklist

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

Must have

Male or female aged ≥18 and ≤80 years at the time of signing the informed consent form.

The subject should have applied a stable dose of non-medicated, non-prescription, topical emollient at least twice daily for 7 consecutive days immediately before the baseline visit.

Must not have

Treatment with biologics: (i) any cell-depleting agents including but not limited to rituximab within 6 months prior to the baseline visit or until lymphocyte count returns to normal, whichever is longer; (ii) other biologics (e.g., dupilumab, omalizumab, etc) within 5 half-lives, if known, or 8 weeks prior to baseline visit, whichever is longer.

Demonstrated lack of primary response to treatment with a biologic for the treatment of AD defined as no response to treatment despite complete adherence to the prescribed regimen for at least 3 months (primary non-responders).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 38 weeks (open-label extension period)

Summary

This trial tests if lirentelimab injections can help adults with severe eczema that doesn't improve with creams. The medication aims to reduce skin inflammation and allergic reactions by blocking specific immune cells.

Who is the study for?

Adults aged 18-80 with moderate-to-severe Atopic Dermatitis (AD) not well-controlled by topical treatments can join. They must have used a non-medicated emollient twice daily for a week before the study, have an EASI score ≥16, IGA score ≥3, and at least 10% body surface area affected. Those who haven't responded to or can't use certain topical meds due to side effects are eligible. People currently on biologics or those without primary response to biologic treatment for AD are excluded.

What is being tested?

The trial is testing Lirentelimab (AK002), administered subcutaneously every two weeks for seven doses against a placebo in adults with AD inadequately controlled by topical treatments. It's randomized and double-blind, meaning neither participants nor researchers know who gets the real drug versus placebo during the test phase.

What are the potential side effects?

While specific side effects of Lirentelimab aren't listed here, similar medications may cause reactions at injection sites, increased risk of infections, potential allergic responses, headaches, nausea and fatigue among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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I have used a regular skin moisturizer twice daily for the last week.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken any cell-depleting drugs or other biologics recently.

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I did not improve after 3 months of treatment with a biologic for AD.

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I haven't used specific skin or immune system treatments in the last 4 weeks.

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I haven't used any skin creams for eczema in the last week.

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I am currently using biologic medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 38 weeks (open-label extension period)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 38 weeks (open-label extension period)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 38 weeks (open-label extension period) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The Proportion of Subjects Who Achieve 75% Improvement on the Eczema Area and Severity Index (EASI-75) at Week 14

Secondary study objectives

Percent Change in EASI From Baseline to Week 14

Proportion of Subjects Achieving an IGA Score of 0 or 1 and a 2-point Improvement at Week 14 vs Baseline

Other study objectives

Safety and Tolerability of up to 7 Doses of Open-label AK002 in Subjects With Atopic Dermatitis in the Open-label Extension Period

Side effects data

From 2023 Phase 3 trial • 94 Patients • NCT04856891

20%

Infusion related reaction

11%

Corona virus infection

Sinusitis

Abdominal pain

Hiatus hernia

Headache

Diabetic ketoacidosis

Diarrhea

Depression

100%

80%

60%

40%

20%

Study treatment Arm

3.0 mg/kg of Lirentelimab (AK002)

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment1 Intervention

Placebo

Group II: Lirentelimab (AK002) SC 300 mgExperimental Treatment1 Intervention

Subjects in this arm will receive 7 doses of 300 mg of lirentelimab (AK002) administered subcutaneously every 2 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AK002

2016

Completed Phase 3

~340

0 / 7Eligibility 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

Common treatments for Atopic Dermatitis (AD) work by targeting specific pathways involved in the inflammatory process. Dupilumab, a monoclonal antibody, inhibits IL-4 and IL-13 signaling, reducing inflammation and improving skin barrier function. JAK inhibitors like ruxolitinib modulate the JAK-STAT pathway, decreasing both inflammation and itch. Lirentelimab (AK002), an investigational drug, targets and depletes eosinophils and mast cells, which are key players in allergic inflammation. These mechanisms are important for AD patients as they offer targeted approaches to manage symptoms and potentially improve quality of life by addressing the specific immune pathways involved in their disease.

Ruxolitinib Cream Has Dual Efficacy on Pruritus and Inflammation in Experimental Dermatitis.Topical application of rapamycin ointment ameliorates Dermatophagoides farina body extract-induced atopic dermatitis in NC/Nga mice.