What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis that target immune pathways, such as monoclonal antibodies like dupilumab, often have side effects including injection site reactions, conjunctivitis, blepharitis, and oral herpes. Other immune-modulating treatments, like JAK inhibitors, may cause nasopharyngitis, headache, and an increased risk of infections. These side effects are generally mild to moderate in severity.

What prior FDA approvals exist?

Dupilumab, a monoclonal antibody that inhibits IL-4 and IL-13 signaling, has been approved by the FDA for the treatment of moderate-to-severe atopic dermatitis. Other similar treatments include tralokinumab, which targets IL-13, and JAK inhibitors like abrocitinib and upadacitinib, which modulate immune pathways. These therapies represent a new generation of targeted treatments for atopic dermatitis, focusing on specific immune pathways involved in the disease.

What other types of research exist?

Promising alternatives to OpSCF for Atopic Dermatitis patients include Dupilumab, which targets the IL-4 receptor alpha subunit and has shown effectiveness and safety in real-life studies, and KHK4083, an anti-OX40 monoclonal antibody that demonstrated continued improvement in EASI and IGA scores with an acceptable safety profile. Additionally, Tralokinumab, which neutralizes IL-13, has shown sustained efficacy when combined with topical corticosteroids in clinical trials.

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Monoclonal Antibodies

OpSCF for Eczema

Phase 2

Waitlist Available

Research Sponsored by Opsidio, LLC

Eligibility Criteria Checklist

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

Must have

Subject has clinically confirmed diagnosis of active AD

Be older than 18 years old

Must not have

Subject has used dupilumab within 26 weeks prior to Day 1

Subject has used tralokinumab within 12 weeks prior to Day 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, approximately 1 year including the open label extension phase

Summary

This trial is testing a new medicine called OpSCF for adults with moderate to severe eczema. OpSCF works by blocking proteins that cause skin inflammation. The study will evaluate if OpSCF is effective and safe.

Who is the study for?

Adults with a confirmed diagnosis of moderate to severe Atopic Dermatitis (Eczema) for at least 6 months can join. They must be willing to use effective birth control. Those who are pregnant, breastfeeding, planning pregnancy during the study, or have used certain medications like dupilumab and tralokinumab recently cannot participate.

What is being tested?

The trial is testing OpSCF, a monoclonal antibody against a placebo in adults with Eczema. Participants will receive injections every two weeks for 14 weeks and then may enter an extension phase receiving OpSCF every four weeks for another 40 weeks.

What are the potential side effects?

While specific side effects of OpSCF aren't listed here, monoclonal antibodies can cause reactions at the injection site, fever, chills, nausea, fatigue, headache and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with active Alzheimer's disease.

Exclusion Criteria

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

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I have used dupilumab within the last 6 months.

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I have used tralokinumab within the last 12 weeks.

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I am currently breastfeeding, pregnant, or planning to become pregnant during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, approximately 1 year including the open label extension phase

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, approximately 1 year including the open label extension phase

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 1 year including the open label extension phase for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percent change in Eczema Area and Severity Index (EASI) score from baseline at Week 16

Secondary study objectives

Change and percent change from baseline in weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS)

Incidence of AEs and SAEs

Proportion of subjects achieving at least a 2-grade reduction from baseline to clear (0) or almost clear (1) in vIGA-AD

Other study objectives

Change from baseline in blood biomarkers and IgE at Weeks 4, 8, 12, and 16

Change from baseline in skin biomarkers collected using skin biopsies at Weeks 4 and 16 (optional for consenting subjects)

Change from baseline in skin biomarkers collected using tape strips at Weeks 4 and 16 (optional for consenting subjects)

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Open Label ExtensionActive Control2 Interventions

Subjects may choose to continue in an Open Label Extension (OLE) phase if they complete the randomized phase. All subjects regardless of treatment assignment in the randomized phase will receive OpSCF, 600 mg every 4 weeks for up to 36 weeks.

Group II: OpSCFActive Control1 Intervention

OpSCF, 600 mg, subcutaneously, every two weeks x 14 weeks

Group III: PlaceboPlacebo Group1 Intervention

Matched placebo, subcutaneously, every two weeks x 14 weeks

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) often target the immune pathways involved in the inflammatory response. Monoclonal antibodies, such as those being studied in the OpSCF trial, work by specifically targeting and neutralizing cytokines or their receptors that play a key role in the pathogenesis of AD. For example, dupilumab targets the IL-4 and IL-13 pathways, which are crucial in the inflammatory process of AD. By inhibiting these pathways, these treatments reduce inflammation, alleviate symptoms, and improve skin barrier function. This is particularly important for AD patients as it directly addresses the underlying immune dysregulation, leading to more effective and sustained symptom control compared to traditional therapies.

Phase 2, randomized, double-blind, placebo-controlled, 4-week study to evaluate the safety and efficacy of OPA- 15406 (difamilast), a new topical selective phosphodiesterase type-4 inhibitor, in Japanese pediatric patients aged 2-14 years with atopic dermatitis.The skin as an immune organ: Tolerance versus effector responses and applications to food allergy and hypersensitivity reactions.