Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06316297
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-03-12
Brief Title:
Study to Evaluate Safety Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase III 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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 III 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
The aim of this first-in-human FIH Phase III 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1295-3154 | REGISTRY | ICTRP | None |