What side effects are associated with this type of intervention?

Common treatments for Atopic Dermatitis, particularly those involving immune modulation and anti-inflammatory effects, include topical corticosteroids, topical immunomodulators, and newer agents like JAK inhibitors and anti-IL-31 antibodies. Topical corticosteroids can cause skin thinning, especially with higher potency formulations. Topical immunomodulators may lead to local skin irritation and a potential increased risk of infections. JAK inhibitors, such as baricitinib, have been associated with nasopharyngitis and headache. Anti-IL-31 antibodies, like nemolizumab, have shown mild adverse events, including exacerbation of atopic dermatitis. Overall, while these treatments are generally effective, they come with a range of potential side effects that should be monitored.

What prior FDA approvals exist?

The FDA has approved several treatments for atopic dermatitis, particularly focusing on immune modulation and anti-inflammatory effects. Dupilumab, a monoclonal antibody that inhibits IL-4 and IL-13 signaling, is a prominent biologic approved for moderate-to-severe atopic dermatitis. Other systemic therapies include cyclosporine, methotrexate, and azathioprine, which have been evaluated for their efficacy in reducing the clinical signs of the disease. These treatments aim to modulate the immune response and reduce inflammation, providing relief for patients with severe forms of atopic dermatitis.

What other types of research exist?

Promising novel alternatives to new drugs or biologics for atopic dermatitis in 2024 include small molecule inhibitors like Janus kinase (JAK) inhibitors, phosphodiesterase-4 (PDE4) inhibitors, and topical treatments such as crisaborole. These treatments offer targeted immune modulation and anti-inflammatory effects without being classified as biologics.

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Other

ADX-914 for Atopic Dermatitis

Phase 2

Waitlist Available

Research Sponsored by Q32 Bio Inc.

Eligibility Criteria Checklist

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

Must have

Age ≥18 years, inclusive, at time of informed consent, with chronic AD (duration of disease ≥3 years) diagnosed by the Eichenfield revised criteria of Hanifin and Rajka

Moderate to severe disease activity at baseline and screening defined as: BSA affected ≥10%, EASI Score ≥12, Investigators Global Score (IGA) ≥3

Must not have

Other concomitant skin conditions that would interfere with evaluations of the effect of study medication on atopic dermatitis

A positive QuantiFERON®TB Gold test at Screening or history of tuberculosis (TB)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Summary

This trial is testing a new drug called ADX-914 in adults with moderate to severe Atopic Dermatitis. The drug is given as an injection over a period of a few months. It aims to reduce skin inflammation and improve skin condition.

Who is the study for?

Adults over 18 with chronic Atopic Dermatitis for at least 3 years, showing moderate to severe symptoms despite previous treatments. Excluded are those with recent serious infections, other skin conditions, participation in another trial within the last month or so, exposure to live vaccines recently or during the study, TB history, pregnant or breastfeeding women, known allergies to study treatments and those with certain autoimmune diseases.

What is being tested?

The trial is testing ADX-914 against a placebo in adults with moderate to severe Atopic Dermatitis. It's a phase IIa study where participants don't know if they're getting the real medicine or a dummy pill (double-blind), and neither do the doctors (placebo-controlled).

What are the potential side effects?

While specific side effects of ADX-914 aren't listed here, common side effects for dermatitis treatments include skin irritation or burning sensation at application site, itching, redness and possible infection due to weakened skin barrier.

Eligibility Criteria

Inclusion Criteria

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

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I am over 18 and have had chronic AD for 3+ years, diagnosed by a specific criteria.

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My skin condition affects more than 10% of my body and is moderate to severe.

Exclusion Criteria

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

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I do not have skin conditions that could affect study results.

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I have tested positive for TB or have a history of it.

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I might need additional therapy within the next month.

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I have a serious illness that might affect my participation in the study.

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My weight is over 120 kg or under 50 kg for men and 45 kg for women.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Part A and B: Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score at Week 14 for ADX-914 vs placebo

Secondary study objectives

Incidence of adverse events

Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score

Mean percentage change from baseline in Scoring Atopic Dermatitis (SCORAD) score

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ADX-914Experimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ADX-914

2020

Completed Phase 1

~50

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

The most common treatments for Atopic Dermatitis (AD) include topical corticosteroids, calcineurin inhibitors (like tacrolimus and pimecrolimus), and biologics such as dupilumab. Topical corticosteroids reduce inflammation by suppressing the immune response in the skin. Calcineurin inhibitors also modulate the immune system by inhibiting T-cell activation, which reduces inflammation and immune-mediated skin damage. Dupilumab, a monoclonal antibody, targets the interleukin-4 receptor alpha, thereby inhibiting the signaling pathways of IL-4 and IL-13, which are key drivers of the inflammatory response in AD. These treatments are crucial for AD patients as they help manage chronic inflammation, reduce symptoms like itching and redness, and improve overall skin health, thereby enhancing the quality of life.