NCT06101823

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

A Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of OpSCF in the Treatment of Adult Subjects With Moderate to Severe Atopic Dermatitis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Opsidio, LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
BIOLOGICAL	OpSCF	Monoclonal Antibody
BIOLOGICAL	Placebo	Formulation buffer without active agent
BIOLOGICAL	OpSCF (Open Label Extension)	Subjects may continue on an Open Label Extension after completing the 16-week randomized portion of the study

Timeline

• Start date: 2023-10-25
• Primary completion: 2024-10-01
• Completion: 2025-06-01
• First posted: 2023-10-26
• Last updated: 2024-05-07

Locations

22 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study