← Back to Search

Monoclonal Antibodies

OpSCF for Eczema

Phase 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.

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

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

0 / 1Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must an individual meet to be eligible for this experiment?

"This experimental trial is in search of 48 volunteers with atopic dermatitis, aged 18 to 75."

Answered by AI

Is there an upper limit to the age of participants in this medical trial?

"This trial demands that all participants are aged between 18 and 75. Notably, 94 studies have been conducted with minors and 176 for individuals over the senior age threshold of 65 years old."

Answered by AI

Has OpSCF achieved regulatory clearance from the Food and Drug Administration?

"The safety rating of OpSCF is a 2 as, though there is some evidence to suggest its security, no prior clinical trials have been conducted which signify efficacy."

Answered by AI

Are there still opportunities to enroll in this research initiative?

"As of October 25th 2023, the trial posted on clinicaltrials.gov is no longer looking for participants; however, there are still 243 other experiments actively recruiting patients."

Answered by AI

How widely dispersed is the implementation of this clinical trial?

"Unison Clinical Trials in Sherman Oaks, Skin care Research in Boca Raton, and RM Medical Research in Miami Lakes are 3 of the 16 clinical trial sites that currently have patients enrolled."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 2a Study of Efficacy and Safety of OpSCF in Moderate to Severe Atopic Dermatitis

2023. "Phase 2a Study of Efficacy and Safety of OpSCF in Moderate to Severe Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06101823.

All > Paid Studies Seattle > Madison