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

Opsidio

Status and phase: Active, not recruiting; Phase 2

Conditions: Atopic Dermatitis

Treatments: Biological: OpSCF; Biological: Placebo; Biological: OpSCF (Open Label Extension)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06101823

OpSCF-201

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has clinically confirmed diagnosis of active AD
• Subject has at least a 6-month history of AD
• Subject is willing to use effective birth control

Exclusion criteria

• Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
• Subject has any clinically significant medical condition that would put the subject at undue risk or interfere with interpretation of study results.
• Subject has used dupilumab within 26 weeks prior to Day 1
• Subject has used tralokinumab within 12 weeks prior to Day 1

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 3 patient groups, including a placebo group

OpSCF

Active Comparator group

Description:

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

Treatment:

Biological: OpSCF

Placebo

Placebo Comparator group

Description:

Matched placebo, subcutaneously, every two weeks x 14 weeks

Treatment:

Biological: Placebo

Open Label Extension

Active Comparator group

Description:

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.

Treatment:

Biological: OpSCF (Open Label Extension)

Biological: OpSCF