← Back to Search

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
Awards & highlights

Summary

This trial will test a new antibody to see if it helps adults with eczema. Subjects will get it every 2 weeks for 14 weeks, then may choose to get it every 4 weeks for 40 weeks.

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.Check my eligibility
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.See study design
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
Select...
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:
Select...
I have used dupilumab within the last 6 months.
Select...
I have used tralokinumab within the last 12 weeks.
Select...
I am currently breastfeeding, pregnant, or planning to become pregnant during the study.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent change in Eczema Area and Severity Index (EASI) score from baseline at Week 16
Secondary outcome measures
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 outcome measures
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

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.

Find a Location

Who is running the clinical trial?

Opsidio, LLCLead Sponsor
Innovaderm Research Inc.OTHER
48 Previous Clinical Trials
3,168 Total Patients Enrolled
Martin PhillipsStudy DirectorOpsidio, LLC
~9 spots leftby Oct 2024