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

NCT06101823 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-05-07

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Innovaderm Research Inc.

    collaborator OTHER

  • Opsidio, LLC

    lead INDUSTRY

Principal Investigators

  • Martin Phillips · Opsidio, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-25
Primary Completion
2024-10-31
Completion
2025-06-30
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06101823 on ClinicalTrials.gov