What is the mechanism of action of this treatment?

The most common treatments for Atopic Dermatitis (AD) often involve immunomodulatory agents that target specific cytokines and immune cells involved in the disease's pathogenesis. For instance, dupilumab blocks IL-4 and IL-13, cytokines that play a crucial role in the inflammatory response and skin barrier dysfunction in AD. Nemolizumab targets IL-31, which is associated with chronic itch. These treatments are significant for AD patients as they directly address the underlying immune dysregulation, leading to reduced inflammation, improved skin barrier function, and relief from severe itching, thereby enhancing the overall quality of life.

What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis that target specific immune cells or cytokines, such as dupilumab, nemolizumab, and lebrikizumab, have known side effects. Dupilumab often causes injection site reactions, conjunctivitis, and nasopharyngitis. Nemolizumab can lead to mild adverse events like exacerbation of atopic dermatitis and upper respiratory infections. Lebrikizumab is associated with upper respiratory tract infections, nasopharyngitis, headache, and injection site pain. These side effects are generally mild to moderate in severity.

What prior FDA approvals exist?

Several immunomodulatory agents have been approved by the FDA for the treatment of atopic dermatitis. Dupilumab, an IL-4 receptor alpha antagonist, is one of the most notable, targeting the IL-4 and IL-13 pathways involved in the inflammatory process of atopic dermatitis. Other similar treatments include tralokinumab, which targets IL-13, and various JAK inhibitors like abrocitinib and upadacitinib, which modulate the JAK-STAT signaling pathway. These treatments aim to reduce inflammation and improve symptoms by targeting specific immune pathways implicated in atopic dermatitis.

What other types of research exist?

Promising novel alternatives to ANB032 for atopic dermatitis treatment in 2024 include dupilumab (IL-4 receptor antagonist), secukinumab (IL-17 inhibitor), ixekizumab (IL-17 inhibitor), and guselkumab (IL-23 inhibitor).

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Monoclonal Antibodies

ANB032 for Eczema

Phase 2

Waitlist Available

Research Sponsored by AnaptysBio, Inc.

Eligibility Criteria Checklist

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

Must have

AD involved BSA ≥ 10% at Screening and at Randomization

History of inadequate response to treatment for AD with topical medications or for whom topical treatments are otherwise medically inadvisable

Must not have

Not able to tolerate SC drug administration

Known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject's immune status

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 14

Summary

This trial is testing a new treatment called ANB032 for people with moderate to severe atopic dermatitis, a skin condition that causes itching and inflammation. The study will check if ANB032 is safe and effective in reducing these symptoms by targeting the immune system. Researchers want to see if this new treatment can help those who have not responded well to other treatments.

Who is the study for?

Adults aged 18-65 with moderate to severe atopic dermatitis (AD) for at least 6 months, who haven't responded well to topical treatments or can't use them. Participants must have certain scores on AD severity scales and at least 10% of their body surface area affected.

What is being tested?

The trial is testing ANB032 against a placebo to see if it's safe, tolerable, and effective in treating AD. Patients will be randomly assigned to receive either the actual drug or a placebo without knowing which one they're getting.

What are the potential side effects?

Specific side effects are not listed but generally could include reactions at the injection site, potential immune system changes due to the nature of the drug being tested, and other unforeseen responses related to safety and tolerability.

Eligibility Criteria

Inclusion Criteria

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

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My skin condition affects more than 10% of my body.

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Topical treatments for my skin condition were ineffective or not recommended for me.

Exclusion Criteria

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

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I cannot tolerate drugs given under the skin.

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I have a condition that weakens my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 14 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of subjects who achieve ≥75% reduction (improvement) from Baseline in EASI-75 as Week 14

Secondary study objectives

Mean percent change from Baseline in EASI at Week 14

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: ANB032 SC Dose 3Experimental Treatment1 Intervention

This arm will receive treatment SC

Group II: ANB032 SC Dose 2Experimental Treatment1 Intervention

This arm will receive treatment SC

Group III: ANB032 SC Dose 1Experimental Treatment1 Intervention

This arm will receive treatment SC

Group IV: PlaceboPlacebo Group1 Intervention

This arm will receive Placebo SC

0 / 4Eligibility 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

The most common treatments for Atopic Dermatitis (AD) often involve immunomodulatory agents that target specific cytokines and immune cells involved in the disease's pathogenesis. For instance, dupilumab blocks IL-4 and IL-13, cytokines that play a crucial role in the inflammatory response and skin barrier dysfunction in AD. Nemolizumab targets IL-31, which is associated with chronic itch. These treatments are significant for AD patients as they directly address the underlying immune dysregulation, leading to reduced inflammation, improved skin barrier function, and relief from severe itching, thereby enhancing the overall quality of life.