OpSCF for Eczema

Recruiting in Palo Alto (17 mi)

+22 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Opsidio, LLC

Prior Safety Data

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.

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

+1 more

Participant Groups

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.

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