Acne Clinical Trial
Official title:
A Phase I/II, Randomized, Placebo-controlled, Multi-arm, Dose-finding Study to Evaluate the Safety, Efficacy and Immunogenicity of an Acne mRNA Vaccine Candidate in Adults With Moderate to Severe Acne 18 to 45 Years of Age
The purpose of the trial is to evaluate the safety, efficacy and immunogenicity of one or two intramuscular injections of the Acne mRNA vaccine candidate at three dose levels in adult participants aged 18 to 45 years with moderate to severe acne in the US.
Acne vulgaris (acne) is a highly prevalent inflammatory skin disease, especially in adolescents and young adults. Acne is estimated to affect 231 million people worldwide, therefore being one of the most prevalent diseases globally. Acne is also one of the top causes of years lived with disability and nonfatal disease burden. Despite being one of the most prevalent diseases worldwide, the mainstays of acne treatment have remained largely unchanged over the past 30 years. To date there is still no effective treatment that can prevent and cure this disease. The aim of this first-in-human (FIH), Phase I/II trial is to evaluate the safety, efficacy and immunogenicity of the Acne mRNA vaccine candidate at three different dose levels in adults aged 18 to 45 years with moderate to severe acne. The study is designed to assess the safety profile and efficacy (also long-term) of the vaccine candidate, select the dose for the further clinical development steps and to describe the immunogenicity profile of the vaccine. ;
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