What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis, particularly biologic agents like dupilumab, can cause side effects such as injection site reactions, conjunctivitis, and nasopharyngitis. Nemolizumab, targeting IL-31, may lead to mild adverse events including exacerbation of atopic dermatitis. JAK inhibitors often result in nasopharyngitis and headache. While these treatments are generally safe, they require monitoring for specific adverse effects.

What prior FDA approvals exist?

The FDA has approved several biologic agents for the treatment of atopic dermatitis, focusing on targeting specific pathways involved in the disease. Dupilumab, an IL-4 and IL-13 inhibitor, is a notable example, showing efficacy in moderate-to-severe cases. Other treatments include JAK inhibitors like baricitinib and upadacitinib, which modulate the JAK-STAT pathway to reduce inflammation. Additionally, nemolizumab, an anti-IL-31 antibody, has shown promise in controlling pruritus associated with atopic dermatitis. These treatments highlight the trend towards targeted biologic therapies in managing atopic dermatitis.

What other types of research exist?

Promising novel alternatives to BSI-045B for atopic dermatitis patients include Dupilumab, an IL-4 receptor alpha antagonist, and Janus kinase (JAK) inhibitors such as Upadacitinib and Abrocitinib. These agents have demonstrated significant efficacy and safety in recent clinical trials for moderate to severe AD.

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Monoclonal Antibodies

BSI-045B + Dupilumab for Eczema (ADAMANT Trial)

Phase 2

Recruiting

Led By James Appel, MD

Research Sponsored by Biosion, Inc.

Eligibility Criteria Checklist

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

Must have

A male patient who is non-sterilized and sexually active with a female partner of childbearing potential, and female patient of childbearing potential who is sexually active with a non-sterilized male partner agrees to use highly effective contraception from the time of signing the ICF throughout the duration of the study and for 90 days (~5 half lives) after the last dose of study drug.

The patient is aged 18 to 65 years, inclusive at the time of consent. Patients of any gender are eligible.

Must not have

The patient has a history of a clinically significant infection within 4 weeks prior to Screening.

The patient is compulsorily detained for a medical or psychiatric illness.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 37

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called BSI-045B, either alone or with another drug called dupilumab, in patients with moderate to severe atopic dermatitis. Dupilumab is a treatment option newly licensed for adolescents with moderate to severe atopic dermatitis (AD). The treatment involves regular injections, aiming to reduce inflammation and skin symptoms.

Who is the study for?

Adults aged 18-65 with moderate to severe atopic dermatitis (AD) can join this trial. They must have an Eczema Area and Severity Index (EASI) score of ≥12, affected body surface area (BSA) ≥10%, and an Investigator's Global Assessment (IGA) score of ≥3. Participants should agree to use effective contraception if applicable. Those on stable dupilumab therapy but still with active AD may also qualify for add-on therapy cohorts.

What is being tested?

The study tests BSI-045B as a solo treatment or alongside dupilumab in people with AD. It has four groups: two will receive different doses of BSI-045B alone, and two will get these doses plus ongoing dupilumab treatment. The drug is given weekly for three weeks, then every other week up to Week 24.

What are the potential side effects?

Possible side effects include reactions at the injection site, general discomfort, potential immune system responses leading to inflammation or allergic reactions, fatigue, and issues related to skin conditions worsening.

Eligibility Criteria

Inclusion Criteria

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

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I agree to use effective birth control during and 90 days after the study.

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I am between 18 and 65 years old.

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At least 10% of my skin is affected by my condition.

Exclusion Criteria

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

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I have had a serious infection within the last month.

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I am currently detained for medical or psychiatric reasons.

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I do not plan to use any prohibited medications or undergo prohibited procedures during the study.

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I have difficulty with needle insertions due to poor vein access.

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I have not donated or lost more than 450 mL of blood, nor had a transfusion in the last 90 days.

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My recent blood tests show abnormal liver, kidney, or blood cell levels.

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I have not had major surgery or dental work in the last 8 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 37

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 37

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 37 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 patients with EASI75 (Eczema Area and Severity Index 75) at Week 12

Safety profile of study treatment

Secondary study objectives

Immunogenicity

PD/biomarkers

Pharmacokinetic parameters

Other study objectives

Exploratory endpoint, EASI reduction at week 12

Exploratory endpoint, EASI reduction at week 24

Exploratory endpoint, IGA improvement

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: 480 mg Monotherapy CohortExperimental Treatment1 Intervention

BSI-045B 480 mg SC QW × 3 weeks, then BSI-045B 480 mg SC Q2W through Week 24

Group II: 480 mg Add-on Therapy CohortExperimental Treatment2 Interventions

BSI-045B 480 mg SC QW × 3 weeks, then BSI-045B 480 mg SC Q2W through Week 24; to be administered concomitantly with steady-state dupilumab

Group III: 300 mg Monotherapy CohortExperimental Treatment1 Intervention

BSI-045B 300 mg SC QW × 3 weeks, then BSI-045B 300 mg SC Q2W through Week 24

Group IV: 300 mg Add-on Therapy CohortExperimental Treatment2 Interventions

BSI-045B 300 mg SC QW × 3 weeks, then BSI-045B 300 mg SC Q2W through Week 24; to be administered concomitantly with steady-state dupilumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BSI-045B

2021

Completed Phase 1

~60

Dupilumab

2017

Completed Phase 4

~11960

0 / 10Eligibility 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 biologic agents, topical corticosteroids, calcineurin inhibitors, and JAK inhibitors. Biologic agents like dupilumab and potentially BSI-045B target specific immune pathways, such as IL-4 and IL-13, reducing inflammation and pruritus. Topical corticosteroids suppress the overall immune response, decreasing inflammation and itching. Calcineurin inhibitors, like tacrolimus, inhibit T-cell activation, reducing immune-mediated skin inflammation. JAK inhibitors block the Janus kinase pathway, which is involved in the inflammatory process. These treatments are crucial for AD patients as they address the underlying immune dysregulation, providing relief from chronic symptoms and improving quality of life.

[The role of emollients in atopic dermatitis in children].