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NCT06316297 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne
A Phase 1 study of Acne, sponsored by Sanofi Pasteur, a Sanofi Company.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 260
- Enrollment target
- 20
- Study locations
NCT06316297: Recruiting Phase 1 study of Acne, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT06316297 is a Phase 1 study of Acne that is actively recruiting participants, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 260 participants, above the 133-participant average among 26 other Acne trials with a reported enrollment target (95% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06316297, a Phase 1 study of Acne, is actively recruiting participants, sponsored by Sanofi Pasteur, a Sanofi Company.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 260 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the trial is to evaluate the safety, efficacy and immunogenicity of up to 3 intramuscular injections of the Acne mRNA vaccine candidate at up to three dose levels in adult participants aged 18 to 45 years with moderate to severe acne. This trial will consist of a Core Study followed by an optional Long-Term Extension (LTE). The Core Study will consist of a Sentinel Cohort A paired with a Main Cohort, evaluating the safety and efficacy of the 2-administration regimen and a Sentinel Cohort B, evaluating the safety of the 3- administration regimen. The Sentinel Cohorts will assess the safety of the dose levels and regimens in a stepwise manner. If the participants consent to the LTE, they will be followed up for an additional 30 months after the last planned visit in the Core Study, to assess the long-term effects of the vaccine.
Primary Outcome
Presence of unsolicited systemic adverse events (AEs) reported
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Acne mRNA vaccine
Study Locations (20)
California
- Private Practice - Dr. Francisco Badar- Site Number : 8400067 - Cerritos
- Encino Research Center- Site Number : 8400033 - Encino
- Paradigm Clinical Research Centers- Site Number : 8400064 - La Mesa
- Sunwise Clinical Research- Site Number : 8400108 - Lafayette
- Chemidox Clinical Trials- Site Number : 8400075 - Lancaster
- Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400058 - Los Angeles
- LA Universal Research Center- Site Number : 8400059 - Los Angeles
- Alliance Clinical - West Hills- Site Number : 8400131 - Los Angeles
- Carbon Health - North Hollywood - NoHo West- Site Number : 8400076 - North Hollywood
- Northridge Clinical Trials - Northridge- Site Number : 8400053 - Northridge
- Profound Research - Dermatologist Medical Group of North County- Site Number : 8400099 - Oceanside
- Cura Clinical Research - Oxnard- Site Number : 8400062 - Oxnard
- Amicis Research Center, LLC- Site Number : 8400110 - Palmdale
- Empire Clinical Research - Pomona- Site Number : 8400055 - Pomona
- Peninsula Research Associates- Site Number : 8400102 - Rolling Hills Estates
- Artemis Institute for Clinical Research, LLC- Site Number : 8400103 - San Diego
- California Research Foundation- Site Number : 8400095 - San Diego
- NorthBay Clinical Research- Site Number : 8400066 - Santa Rosa
Arizona
- Center for Dermatology and Plastic Surgery- Site Number : 8400111 - Scottsdale
Florida
- Encore Medical Research of Boynton Beach- Site Number : 8400116 - Boynton Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2024-04-05 |
| Est. Completion | 2028-08-31 |
| Phase | Phase 1 |
What NCT06316297 shows while recruiting
NCT06316297 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 26 other Acne trials with a reported enrollment target (95% higher).
The record links to 1 condition, with Acne appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06316297 names 20 study sites across 3 states, led by California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT06316297 about?
NCT06316297 is a clinical study titled "Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne". The purpose of the trial is to evaluate the safety, efficacy and immunogenicity of up to 3 intramuscular injections of the Acne mRNA vaccine candidate at up to three dose levels in adult participants aged 18 to 45 years with moderate to severe acne. This trial will consist of a Core Study followed ...
What is the current status of trial NCT06316297?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 260 participants. The study started on 2024-04-05. Estimated completion is 2028-08-31.
What conditions does trial NCT06316297 study?
This clinical trial studies the following conditions: Acne.
What interventions are being tested in trial NCT06316297?
The interventions under investigation include: Placebo (OTHER), Acne mRNA vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT06316297?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06316297 being conducted?
This trial has 20 study locations across Arizona, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acne
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06316297's enrollment target sits among peer trials
260 4th of 26 higher than 23 of 26 other Acne trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acne trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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