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

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT06101823

Run by

Opsidio, LLC

People needed

48

Starts

2023-10-25

Expected to finish

2025-06-01

Last updated by the study team

2024-05-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cahaba Dermatology & Skin Health Center — Birmingham, Alabama, United States
• First OC Dermatology Research — Fountain Valley, California, United States
• Axon Clinical Research — Inglewood, California, United States
• University Clinical Trials — San Diego, California, United States
• Unison Clinical Trials — Sherman Oaks, California, United States
• Skin Care Research — Boca Raton, Florida, United States
• Skin Research of South Florida — Miami, Florida, United States
• RM Medical Research — Miami Lakes, Florida, United States
• Advanced Clinical Research Institute — Tampa, Florida, United States
• Arlington Dermatology — Rolling Meadows, Illinois, United States
• Options Research Group — West Lafayette, Indiana, United States
• DS Research of Kentucky — Louisville, Kentucky, United States
• Oakland Hills Dermatology P.C — Auburn Hills, Michigan, United States
• Saginaw Bay Dermatology — Bay City, Michigan, United States
• Skin Cancer and Dermatology Institute — Reno, Nevada, United States
• Forest Hills Dermatology Group — Kew Gardens, New York, United States
• Rodgers Dermatology — Frisco, Texas, United States
• Dermatology Of Seattle — Bellevue, Washington, United States
• Oshawa Clinic Dermatology Trials — Oshawa, Ontario, Canada
• Research Toronto — Toronto, Ontario, Canada
• Innovaderm Research Inc — Montreal, Quebec, Canada
• Centre de Recherche Saint-Louis — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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