Clinical trial NCT06101823: Phase 2a Study of Efficacy and Safety of OpSCF in Moderate to Severe Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Eczema
Monoclonal Antibody
Lead sponsor: Opsidio, LLC
Sponsor class: INDUSTRY
Collaborators: name: Innovaderm Research Inc.
First posted: 2023-10-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo controlled
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent change in Eczema Area and Severity Index (EASI) score from baseline at Week 16
timeFrame: 16 weeks
Secondary outcomes:
measure: Incidence of AEs and SAEs
timeFrame: Through study completion, approximately 1 year including the open label extension phase
measure: Proportion of subjects achieving at least a 2-grade reduction from baseline to clear (0) or almost clear (1) in vIGA-AD
timeFrame: 16 weeks
measure: Change and percent change from baseline in weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS)
timeFrame: 16 weeks
Other outcomes:
measure: Change from baseline in blood biomarkers and IgE at Weeks 4, 8, 12, and 16
timeFrame: 16 weeks
measure: Change from baseline in skin biomarkers collected using skin biopsies at Weeks 4 and 16 (optional for consenting subjects)
timeFrame: 16 weeks
measure: Change from baseline in skin biomarkers collected using tape strips at Weeks 4 and 16 (optional for consenting subjects)
timeFrame: 16 weeks
Locations:
city: Birmingham
country: United States
facility: Cahaba Dermatology & Skin Health Center
state: Alabama
city: Fountain Valley
country: United States
facility: First OC Dermatology Research
state: California
city: Inglewood
country: United States
facility: Axon Clinical Research
state: California
city: San Diego
country: United States
facility: University Clinical Trials
state: California
city: Sherman Oaks
country: United States
facility: Unison Clinical Trials
state: California
city: Boca Raton
country: United States
facility: Skin Care Research
state: Florida
city: Miami Lakes
country: United States
facility: RM Medical Research
state: Florida
city: Miami
country: United States
facility: Skin Research of South Florida
state: Florida
city: Tampa
country: United States
facility: Advanced Clinical Research Institute
state: Florida
city: Rolling Meadows
country: United States
facility: Arlington Dermatology
state: Illinois
city: West Lafayette
country: United States
facility: Options Research Group
state: Indiana
city: Louisville
country: United States
facility: DS Research of Kentucky
state: Kentucky
city: Auburn Hills
country: United States
facility: Oakland Hills Dermatology P.C
state: Michigan
city: Bay City
country: United States
facility: Saginaw Bay Dermatology
state: Michigan
city: Reno
country: United States
facility: Skin Cancer and Dermatology Institute
state: Nevada
city: Kew Gardens
country: United States
facility: Forest Hills Dermatology Group
state: New York
city: Frisco
country: United States
facility: Rodgers Dermatology
state: Texas
city: Bellevue
country: United States
facility: Dermatology Of Seattle
state: Washington
city: Oshawa
country: Canada
facility: Oshawa Clinic Dermatology Trials
state: Ontario
city: Toronto
country: Canada
facility: Research Toronto
state: Ontario
city: Montréal
country: Canada
facility: Innovaderm Research Inc
state: Quebec
city: Québec City
country: Canada
facility: Centre de Recherche Saint-Louis
state: Quebec
Study officials:
affiliation: Opsidio, LLC
name: Martin Phillips
role: STUDY_DIRECTOR
References: