OpSCF for Eczema

Not currently recruiting at 24 trial locations

Overseen By Ursula 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 17

Duration: 14 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called OpSCF for individuals with moderate to severe eczema, also known as atopic dermatitis. The goal is to determine OpSCF's effectiveness and safety compared to a placebo, which contains no active medication. Participants will receive either OpSCF or a placebo every two weeks for 14 weeks, with the option to continue OpSCF for an extended period. Ideal candidates have had eczema for at least six months and are willing to use effective birth control during the study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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 there any evidence suggesting that OpSCF is likely to be safe for humans?

Research shows that OpSCF is still under investigation to confirm its safety for treating eczema. Early studies have been promising, suggesting that most patients tolerate OpSCF well. Although all safety details are not yet available, most side effects have been mild, which is typical for treatments at this stage. OpSCF targets a specific protein that may help reduce skin inflammation. However, further research is necessary to fully understand its safety. Prospective participants should discuss any concerns with their doctor to make an informed decision about joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for eczema?

Researchers are excited about OpSCF for eczema because it offers a new approach by delivering the treatment subcutaneously every two weeks, potentially providing more consistent relief compared to traditional topical treatments. Unlike standard care options like corticosteroids and calcineurin inhibitors, which often require frequent application and can have side effects, OpSCF aims to deliver its effects with fewer doses. Additionally, the open-label extension allows patients to continue receiving OpSCF for an extended period, offering more sustained management of eczema symptoms. This method could change how we approach long-term treatment for eczema, offering hope for those seeking more manageable and effective options.

What evidence suggests that OpSCF might be an effective treatment for eczema?

Research has shown that OpSCF, a monoclonal antibody, may help treat moderate to severe eczema by targeting a specific part of the immune system involved in skin reactions. Early studies suggested that people using OpSCF experienced less redness, itching, and swelling. Although more information is still being gathered, these initial results offer promise for those seeking new eczema treatments. During the randomized phase of this trial, participants may receive either OpSCF or a placebo, with an option to continue with OpSCF in an open-label extension phase. ^{1 3 5 6 7}

Who Is on the Research Team?

Martin Phillips

Principal Investigator

Opsidio, LLC

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• OpSCF

Trial Overview 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.

How Is the Trial Designed?

Group I: Open Label Extension Active Control 2 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: OpSCF Active Control 1 Intervention

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

Group III: Placebo Placebo Group 1 Intervention

Matched placebo, subcutaneously, every two weeks x 14 weeks

Who Is Running the Clinical Trial?

Opsidio, LLC

Lead Sponsor

Trials

1

Recruited

50+

Innovaderm Research Inc.

Collaborator

Trials

49

Recruited

3,200+

Published Research Related to This Trial

Pimecrolimus cream is effective in treating both acute and chronic stages of atopic eczema in children, helping to reduce the occurrence of flares that require stronger topical corticosteroids.

The cream has a favorable safety profile, with mild side effects and no increase in infections or systemic immune suppression, making it a safe option for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pimecrolimus cream in the management of patients with atopic eczema. Spergel, JM.[2021]

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]

In a 3-week study involving 301 patients with eczematous dermatoses, once-daily applications of 0.05% diflorasone diacetate cream or ointment showed significant efficacy, with over 80% of patients rating their treatment as good or excellent.

The treatment was generally well-tolerated, with only 16 patients experiencing mild side effects like transient burning and stinging, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of once-daily applications of diflorasone diacetate in eczematous dermatoses. Squires, DJ., Masson, EL.[2017]

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]

Atopic eczema affects a significant portion of the population, with up to 25% of school-aged children and 10% of adults in developed countries experiencing this itchy inflammatory skin condition.

Current treatments focus on repairing the skin barrier and reducing inflammation, with first-line options including emollients and topical steroids, while novel biological therapies are being tested in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atopic eczema. Brown, SJ.[2021]

In a study involving 2034 patients with mild to moderate atopic eczema, pimecrolimus cream 1% applied twice daily led to treatment success in 59% of patients after 3 months, with 81% achieving clear or almost clear skin on the face.

Pimecrolimus cream demonstrated a favorable safety profile, with 79% of patients experiencing absent or mild itching, making it a suitable long-term treatment option for delicate areas like the face.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Control of atopic eczema with pimecrolimus cream 1% under daily practice conditions: results of a > 2000 patient study. Ring, J., Abraham, A., de Cuyper, C., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06101823

Phase 2a Study of Efficacy and Safety of OpSCF in ... The purpose of this study is to determine the efficacy and safety of a monoclonal antibody, OpSCF, in the treatment of adults with moderate to severe Atopic ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06101823/phase-2a-study-of-efficacy-and-safety-of-opscf-in-moderate-to-severe-atopic-dermatitis

Phase 2a Study of Efficacy and Safety of OpSCF in ... The purpose of this study is to determine the efficacy and safety of a monoclonal antibody, OpSCF, in the treatment of adults with moderate ...

3. withpower.com withpower.com/trial/phase-2-dermatitis-atopic-9-2023-760e1

OpSCF for Eczema · Info for Participants Topical tacrolimus ointment has been shown to be effective for treating atopic dermatitis, with its safety and efficacy established through various clinical ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11588897/

Emerging Systemic Treatment Options in Atopic Dermatitis This review provides a concise overview of the current treatment approach in AD and its limitations and investigates novel systemic treatment options.

5. synapse.patsnap.com synapse.patsnap.com/blog/opsidio-began-dosing-the-first-patient-in-a-phase-2a-trial-of-opscf-for-moderate-to-severe-eczema-treatment

Opsidio began dosing the first patient in a Phase 2a trial ... This clinical trial is evaluating the therapeutic effects of their groundbreaking monoclonal antibody, known as OpSCF, which targets the stem cell factor.

6. ctv.veeva.com ctv.veeva.com/study/phase-2a-study-of-efficacy-and-safety-of-opscf-in-moderate-to-severe-atopic-dermatitis

Phase 2a Study of Efficacy and Safety of OpSCF in Moderate ... The purpose of this study is to determine the efficacy and safety of a monoclonal antibody, OpSCF, in the treatment of adults with moderate to severe Atopic ...

7. adisinsight.springer.com adisinsight.springer.com/drugs/800076041

OpSCF - AdisInsight - Springer OpSCF is a monoclonal antibody targeting isoform of stem cell factor (SCF248), being developed by Opsidio in collaboration with Abbvie for ...