drugset / Trial / NCT06101823

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

NCT06101823 ↗

Phase 2 Unknown 48 enrolled Opsidio, LLC Innovaderm Research Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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 Dermatitis (Eczema). OpSCF will be compared to a placebo. OpSCF or placebo will be administered every 2 weeks for 14 weeks, and the efficacy will be assessed two weeks later. After that, subjects may choose to enter an Open Label Extension phase in which all subjects will receive OpSCF every 4 weeks for 40 additional weeks.

Timeline

Start
2023-10-25
Primary completion
2024-10
Completion
2025-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator OpSCF Monoclonal antibody 600 mg Subcutaneous

Indications