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

Status: Recruiting
Location: See all (93) locations...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests as judged by the investigator

• Clinical diagnosis of moderate or severe facial acne vulgaris with Investigator's Global Assessment (IGA) score of Moderate or Severe (grade 3 or grade 4 on the 5-grade IGA scale) and ≥ 25 non-inflammatory lesions (ie, open and closed comedones) and ≥ 20 inflammatory lesions (ie, papules and pustules) and ≤ 2 nodulocystic lesions (ie, nodules and cysts)

Locations
United States
Arizona
Center for Dermatology and Plastic Surgery- Site Number : 8400111
RECRUITING
Scottsdale
California
Private Practice - Dr. Francisco Badar- Site Number : 8400067
RECRUITING
Cerritos
Encino Research Center- Site Number : 8400033
RECRUITING
Encino
Paradigm Clinical Research Centers- Site Number : 8400064
RECRUITING
La Mesa
Sunwise Clinical Research- Site Number : 8400108
RECRUITING
Lafayette
Chemidox Clinical Trials- Site Number : 8400075
RECRUITING
Lancaster
Alliance Clinical - West Hills- Site Number : 8400131
RECRUITING
Los Angeles
Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400058
RECRUITING
Los Angeles
LA Universal Research Center- Site Number : 8400059
RECRUITING
Los Angeles
Carbon Health - North Hollywood - NoHo West- Site Number : 8400076
RECRUITING
North Hollywood
Northridge Clinical Trials - Northridge- Site Number : 8400053
RECRUITING
Northridge
Profound Research - Dermatologist Medical Group of North County- Site Number : 8400099
RECRUITING
Oceanside
Cura Clinical Research - Oxnard- Site Number : 8400062
RECRUITING
Oxnard
Amicis Research Center, LLC- Site Number : 8400110
RECRUITING
Palmdale
Empire Clinical Research - Pomona- Site Number : 8400055
RECRUITING
Pomona
Peninsula Research Associates- Site Number : 8400102
RECRUITING
Rolling Hills Estates
Artemis Institute for Clinical Research, LLC- Site Number : 8400103
RECRUITING
San Diego
California Research Foundation- Site Number : 8400095
RECRUITING
San Diego
NorthBay Clinical Research- Site Number : 8400066
RECRUITING
Santa Rosa
Florida
Encore Medical Research of Boynton Beach- Site Number : 8400116
RECRUITING
Boynton Beach
Driven Research- Site Number : 8400135
RECRUITING
Coral Gables
HealthMed Clinical Center Inc.- Site Number : 8400071
RECRUITING
Coral Gables
Universal Medical Research - Coral Gables- Site Number : 8400081
RECRUITING
Coral Gables
Genomics Medical Research- Site Number : 8400120
RECRUITING
Cutler Bay
Direct Helpers Research Center- Site Number : 8400118
RECRUITING
Hialeah
Encore Medical Research - Hollywood- Site Number : 8400122
RECRUITING
Hollywood
Zenith Clinical Research- Site Number : 8400127
RECRUITING
Hollywood
Universal Medical and Research Center- Site Number : 8400079
RECRUITING
Homestead
Encore Research Group-Jacksonville Center for Clinical Research- Site Number : 8400006
RECRUITING
Jacksonville
K2 Summit Research LLC - Site Number : 8400063
RECRUITING
Lady Lake
Advanced Medical Research Institute - Miami- Site Number : 8400100
RECRUITING
Miami
Dr. Manuel J Hernandez Clinical Research and Associates, Inc.- Site Number : 8400106
RECRUITING
Miami
Health and Life Research Institute, LLC- Site Number : 8400070
RECRUITING
Miami
SouthCoast Research Center- Site Number : 8400114
RECRUITING
Miami
WellQuest Clinical- Site Number : 8400082
RECRUITING
Miami
Renstar Medical Research - Ocala - Northeast 1st Avenue- Site Number : 8400021
RECRUITING
Ocala
Leading Edge Dermatology- Site Number : 8400077
RECRUITING
Plantation
Nuline Clinical Trial Center- Site Number : 8400060
RECRUITING
Pompano Beach
D&H Tamarac Research Center- Site Number : 8400121
RECRUITING
Tamarac
CenExel FCR Tampa- Site Number : 8400130
RECRUITING
Tampa
Optimum Clinical Trial Group- Site Number : 8400125
RECRUITING
Tampa
TrueBlue Clinical Research- Site Number : 8400016
RECRUITING
Tampa
Georgia
Accel Research Sites - NeuroStudies- Site Number : 8400134
RECRUITING
Decatur
Iowa
Accellacare - McFarland Clinic- Site Number : 8400045
RECRUITING
Ames
The Iowa Clinic West Des Moines Campus- Site Number : 8400084
RECRUITING
West Des Moines
Illinois
MetroMed Clinical Trials- Site Number : 8400054
RECRUITING
Chicago
AMR Chicago- Site Number : 8400019
RECRUITING
Oak Brook
NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400031
RECRUITING
Skokie
Indiana
Dawes Fretzin Clinical Research- Site Number : 8400022
RECRUITING
Indianapolis
Kentucky
Equity Medical - Bowling Green- Site Number : 8400093
RECRUITING
Bowling Green
Louisiana
Louisiana Dermatology Associates- Site Number : 8400043
RECRUITING
Baton Rouge
Clinical Trials Management - Metairie- Site Number : 8400072
RECRUITING
Metairie
DelRicht Research - New Orleans 308- Site Number : 8400013
RECRUITING
New Orleans
Massachusetts
MetroBoston Clinical Partners - Brighton- Site Number : 8400008
RECRUITING
Brighton
Kuchnir Dermatology & Dermatologic Surgery- Site Number : 8400096
RECRUITING
Marlborough
Maryland
Private Practice - Dr. Lawrence J. Green- Site Number : 8400024
RECRUITING
Rockville
Michigan
Michigan Institute of Research- Site Number : 8400092
RECRUITING
Allen Park
Vida Clinical Studies - Dearborn Heights- Site Number : 8400074
RECRUITING
Dearborn Heights
Minnesota
Clinical Research Institute - Minneapolis- Site Number : 8400080
RECRUITING
Minneapolis
Missouri
MediSearch Clinical Trials- Site Number : 8400035
RECRUITING
Saint Joseph
Montana
Boeson Research - Missoula- Site Number : 8400069
RECRUITING
Missoula
North Carolina
Trial Management Associates - Wilmington - Floral Parkway- Site Number : 8400104
RECRUITING
Wilmington
Nevada
Las Vegas Clinical Trials- Site Number : 8400056
RECRUITING
Las Vegas
Oklahoma
Lynn Institute of Oklahoma City- Site Number : 8400004
RECRUITING
Oklahoma City
Pennsylvania
Best Skin Research - Camp Hill- Site Number : 8400017
RECRUITING
Camp Hill
South Carolina
Delricht Research - Mt Pleasant Dermatology- Site Number : 8400047
RECRUITING
Mt. Pleasant
Tennessee
DelRicht Research - Thompson's Station- Site Number : 8400041
RECRUITING
Smyrna
Texas
Inquest Clinical Research - Baytown - West Baker Road- Site Number : 8400115
RECRUITING
Baytown
DFW Clinical Trials- Site Number : 8400057
RECRUITING
Carrollton
Modern Research Associates- Site Number : 8400094
RECRUITING
Dallas
Center for Clinical Studies - Houston - Binz Street- Site Number : 8400002
RECRUITING
Houston
Lone Star Clinical Research - Katy- Site Number : 8400049
RECRUITING
Katy
DelRicht Research - Lockhart Matter Dermatology & Aesthetic Center- Site Number : 8400046
RECRUITING
Prosper
Utah
Cope Family Medicine - Ogden Clinic- Site Number : 8400112
RECRUITING
Bountiful
Alpine Research Association- Site Number : 8400050
RECRUITING
Layton
CenExel JRB - Salth Lake City- Site Number : 8400128
RECRUITING
Salt Lake City
Springville Dermatology - Springville- Site Number : 8400113
RECRUITING
Springville
Virginia
The Education & Research Foundation- Site Number : 8400036
RECRUITING
Lynchburg
Washington
Seattle Clinical Research Center- Site Number : 8400038
RECRUITING
Seattle
Other Locations
Australia
Investigational Site Number : 0360007
RECRUITING
Carlton
Investigational Site Number : 0360008
RECRUITING
Kotara
Investigational Site Number : 0360002
RECRUITING
Melbourne
Investigational Site Number : 0360009
RECRUITING
Melbourne
Investigational Site Number : 0360001
RECRUITING
Phillip
Investigational Site Number : 0360003
RECRUITING
Sydney
Investigational Site Number : 0360006
RECRUITING
Waitara
Investigational Site Number : 0360005
RECRUITING
Woolloongabba
Canada
Investigational Site Number : 1240001
RECRUITING
Barrie
Investigational Site Number : 1240006
RECRUITING
Edmonton
Investigational Site Number : 1240009
RECRUITING
Montreal
Investigational Site Number : 1240007
RECRUITING
Québec
Investigational Site Number : 1240008
RECRUITING
Sherbrooke
Investigational Site Number : 1240004
RECRUITING
Toronto
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2024-04-05
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 260
Treatments
Experimental: Sentinel Cohort A - Experimental
Two administrations of the Acne mRNA vaccine will be injected in three increasing doses
Placebo_comparator: Sentinel Cohort A - Placebo
Two administrations of placebo will be injected
Experimental: Sentinel Cohort B - Experimental
Three administrations of the Acne mRNA vaccine will be injected in two increasing doses
Placebo_comparator: Sentinel Cohort B - Placebo
Three administrations of placebo will be injected
Experimental: Main Cohort - Experimental
Two administrations of the Acne mRNA vaccine will be injected in three increasing doses
Placebo_comparator: Main Cohort - Placebo
Two administrations of placebo will be injected
Related Therapeutic Areas
Sponsors
Leads: Sanofi Pasteur, a Sanofi Company

This content was sourced from clinicaltrials.gov