Apply to Trial

Compensation: Varies

Number of Visits: 17

Duration: 14 weeks

48 Participants Needed

OpSCF for Eczema

Recruiting at 22 trial locations

Overseen ByUrsula Cholewa, MA MBA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Opsidio, LLC

Must not be taking: Dupilumab, Tralokinumab

Disqualifiers: Pregnancy, Breastfeeding, Significant medical condition, others

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used dupilumab within 26 weeks or tralokinumab within 12 weeks before starting the trial.

Is OpSCF safe for use in humans?

Tacrolimus ointment, which may be similar to OpSCF, has been studied for safety in treating eczema. Common side effects include skin burning, itching, flu-like symptoms, and headaches, but these are usually mild and temporary. There is a 'black box' warning due to potential long-term risks, but short-term use is generally considered safe.¹ ² ³ ⁴ ⁵

How does the drug OpSCF differ from other treatments for eczema?

OpSCF is unique because it may offer a novel approach to treating eczema, potentially differing in its mechanism of action or formulation compared to standard treatments like topical steroids and calcineurin inhibitors, which focus on reducing inflammation and maintaining the skin barrier.⁶ ⁷ ⁸ ⁹ ¹⁰

Research Team

Martin Phillips

Principal Investigator

Opsidio, LLC

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with active Alzheimer's disease.

You have been diagnosed with atopic dermatitis for at least 6 months.

Subject is willing to use effective birth control

Exclusion Criteria

I have used dupilumab within the last 6 months.

I have used tralokinumab within the last 12 weeks.

Subject has any clinically significant medical condition that would put the subject at undue risk or interfere with interpretation of study results

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

OpSCF or placebo is administered every 2 weeks for 14 weeks

14 weeks

7 visits (in-person)

Follow-up

Efficacy is assessed two weeks after the treatment phase

2 weeks

1 visit (in-person)

Open-label extension

Participants may opt into continuation of treatment with OpSCF every 4 weeks for up to 36 weeks

36 weeks

9 visits (in-person)

Treatment Details

Interventions

OpSCF

Trial OverviewThe 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.

Participant Groups

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Opsidio, LLC

Lead Sponsor

Trials

Recruited

50+

Innovaderm Research Inc.

Collaborator

Trials

Recruited

3,200+

Findings from Research

In two studies involving 631 adults with moderate to severe atopic dermatitis, tacrolimus ointment (0.03% or 0.1%) was found to be effective, significantly outperforming the vehicle in all measured efficacy parameters over 12 weeks.

While some patients experienced mild adverse events like skin burning and pruritus, these were generally brief and resolved quickly; importantly, tacrolimus ointment was deemed safe, with no significant laboratory changes and low systemic absorption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part II, safety.Soter, NA., Fleischer, AB., Webster, GF., et al.[2022]

Topical corticosteroids (TCS) used for atopic eczema showed no significant increased risk of skin thinning in short-term studies, indicating they are generally safe for use in both adults and children.

While TCS may have a higher relative risk of skin thinning compared to topical calcineurin inhibitors, the overall long-term safety data is limited, suggesting that intermittent use of TCS is safe but requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of topical corticosteroids in atopic eczema: an umbrella review.Axon, E., Chalmers, JR., Santer, M., et al.[2023]

Topical tacrolimus ointment has been shown to be effective for treating atopic dermatitis, with its safety and efficacy established through various clinical trials lasting up to 12 weeks and comparative studies with topical steroids.

Long-term safety studies extending up to 4 years provide additional reassurance about the use of tacrolimus ointment, addressing clinicians' concerns regarding its prolonged use in patients with atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of tacrolimus ointment: a clinical review.Beck, LA.[2013]