What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis that target inflammatory pathways include biologic agents like dupilumab and JAK inhibitors such as baricitinib and abrocitinib. Known side effects of these treatments include nasopharyngitis, headache, nausea, and acne. Dupilumab may also cause conjunctivitis and injection site reactions. JAK inhibitors have been associated with more serious adverse effects, including increased risk of infections and, in rare cases, serious cardiovascular events. Overall, while these treatments can be effective, they require careful monitoring for potential side effects.

What prior FDA approvals exist?

Several biologic agents targeting inflammatory pathways have been approved by the FDA for the treatment of atopic dermatitis. Dupilumab, an IL-4 and IL-13 inhibitor, is one such biologic that has shown efficacy in moderate-to-severe atopic dermatitis. Tralokinumab, another IL-13 inhibitor, has also been approved for similar indications. These treatments work by modulating the immune response to reduce inflammation and alleviate symptoms of atopic dermatitis.

What other types of research exist?

Promising novel alternatives to BxC-I17e for atopic dermatitis patients include LX519290, a synthetic derivative with potential anti-atopic activity, and IL-17 inhibitors such as ixekizumab, which have demonstrated efficacy in related inflammatory conditions. These treatments target key inflammatory pathways and may offer new options for managing atopic dermatitis.

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Monoclonal Antibodies

BxC-I17e for Eczema

Phase 1

Recruiting

Research Sponsored by Brexogen Inc.

Eligibility Criteria Checklist

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

Must have

Patients have documented history of moderate to severe AD, that has been present for at least 1 year

History of inadequate response to a stable regimen of TCSs or TCIs as treatment for AD

Must not have

Known history of human immunodeficiency virus (HIV) infection

Treatment with TCS, and/or TCI, within 1 week prior to the Baseline Visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 8 (single dose) or week 14 (multiple dose)

Summary

This trial is testing a new treatment called BxC-I17e in patients with moderate to severe atopic dermatitis to see if it is safe and effective.

Who is the study for?

Adults over 18 with moderate to severe atopic dermatitis (AD) for at least a year, who haven't responded well to standard creams or ointments. They must use fragrance-free moisturizers twice daily for a week before starting and be able to follow the study plan. Pregnant or breastfeeding women, those in other studies, with serious health issues, certain blood/lab abnormalities, HIV, or recent AD treatments are excluded.

What is being tested?

The trial is testing BxC-I17e's safety and effectiveness against a placebo in one-time subcutaneous injections for people with stubborn eczema. It aims to see if this new treatment can help when regular therapies don't work.

What are the potential side effects?

While specific side effects of BxC-I17e aren't listed here, common ones from similar treatments include injection site reactions, potential immune system changes leading to increased infection risk or allergic responses.

Eligibility Criteria

Inclusion Criteria

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

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I have had moderate to severe atopic dermatitis for at least 1 year.

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I have tried treatments for my skin condition without success.

Exclusion Criteria

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

Select...

I have been diagnosed with HIV.

Select...

I have used topical corticosteroids or inhibitors within the last week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 8 (single dose) or week 14 (multiple dose)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 8 (single dose) or week 14 (multiple dose)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 8 (single dose) or week 14 (multiple dose) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of treatment-emergent adverse events (TEAEs)

Secondary study objectives

Change and percent change in Body Surface Area (BSA)

Change and percent change in Dermatology Life Quality Index (DLQI)

Change and percent change in Eczema Area and Severity Index (EASI)

+9 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: BxC-I17e (Single Dose)Experimental Treatment1 Intervention

* Subcutaneous (SC) injection of 25, 50, or 100 ug BxC-I17e * Single dose on Day 1

Group II: BxC-I17e (Multiple Dose)Experimental Treatment1 Intervention

* Subcutaneous (SC) injection of 50, or 100 ug BxC-I17e * 4 doses on Day 1, 15, 29, and 43

Group III: Placebo (Single Dose)Placebo Group1 Intervention

* Subcutaneous (SC) injection of the matching placebo * Single dose on Day 1

Group IV: Placebo (Multiple Dose)Placebo Group1 Intervention

* Subcutaneous (SC) injection of the matching placebo * 4 doses on Day 1, 15, 29, and 43

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

Common treatments for Atopic Dermatitis (AD) include topical corticosteroids, calcineurin inhibitors, and biologic agents. Topical corticosteroids reduce inflammation and immune responses by inhibiting various inflammatory cytokines. Calcineurin inhibitors, such as tacrolimus and pimecrolimus, block T-cell activation, thereby reducing inflammation and immune activity. Biologic agents, like dupilumab, target specific pathways involved in the inflammatory process, such as the IL-4 and IL-13 pathways, which are crucial in the pathogenesis of AD. These treatments are essential for AD patients as they help manage symptoms, reduce flare-ups, and improve the quality of life by addressing the underlying inflammatory mechanisms.