Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne
August 19, 2026 updated by: Sanofi Pasteur, a Sanofi Company
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 up to 3 intramuscular injections of the Acne mRNA vaccine candidate at up to four 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:
- Two cohorts evaluating the 2-administration regimen (Cohorts A): Sentinel Cohort A and Main Cohort A.
- Two cohorts evaluating the 3-administration regimen (Cohorts B): Sentinel Cohort B and Main Cohort B.
Participants from Sentinel Cohorts A and B and from Main Cohort A will be invited to an additional 30-month follow up after completing their last planned Core Study visit to assess the long-term effects of the vaccine. Participants from Main Cohort B will be invited to another LTE study managed through a separate protocol.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 safe and 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 four different dose levels in adults aged 18 to 45 years with moderate to severe acne. The results of this FIH and proof of concept study will allow selection of the vaccine dose level to be used in Phase III pivotal efficacy trial(s) and to generate preliminary data to further select the vaccine regimen.
Study Type
Interventional
Enrollment (Estimated)
800
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Trial Transparency email recommended (Toll free for US & Canada)
- Phone Number: option 6 800-633-1610
- Email: Contact-US@sanofi.com
Study Locations
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Australian Capital Territory
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Phillip, Australian Capital Territory, Australia, 2606
- Recruiting
- Investigational Site Number : 0360001
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New South Wales
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Kotara, New South Wales, Australia, 2289
- Recruiting
- Investigational Site Number : 0360008
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Sydney, New South Wales, Australia, 2010
- Recruiting
- Investigational Site Number : 0360003
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Waitara, New South Wales, Australia, 2077
- Recruiting
- Investigational Site Number : 0360006
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Queensland
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Woolloongabba, Queensland, Australia, 4102
- Recruiting
- Investigational Site Number : 0360005
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Victoria
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Carlton, Victoria, Australia, 3053
- Recruiting
- Investigational Site Number : 0360007
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Melbourne, Victoria, Australia, 3004
- Recruiting
- Investigational Site Number : 0360002
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Melbourne, Victoria, Australia, 3124
- Recruiting
- Investigational Site Number : 0360009
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Alberta
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Edmonton, Alberta, Canada, T5J 3S9
- Recruiting
- Investigational Site Number : 1240006
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Ontario
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Barrie, Ontario, Canada, L4M 7G1
- Recruiting
- Investigational Site Number : 1240001
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Toronto, Ontario, Canada, M4E 1R7
- Recruiting
- Investigational Site Number : 1240004
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Quebec
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Montreal, Quebec, Canada, H1Y 3L1
- Recruiting
- Investigational Site Number : 1240009
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Québec, Quebec, Canada, G1W 4R4
- Recruiting
- Investigational Site Number : 1240007
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Sherbrooke, Quebec, Canada, J1G 1X9
- Recruiting
- Investigational Site Number : 1240008
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San Juan, Puerto Rico, 00909
- Recruiting
- Investigational Site Number : 6300002
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Arizona
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Scottsdale, Arizona, United States, 85260
- Recruiting
- Center for Dermatology and Plastic Surgery- Site Number : 8400111
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California
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Cerritos, California, United States, 90703
- Recruiting
- Private Practice - Dr. Francisco Badar- Site Number : 8400067
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Encino, California, United States, 91436
- Recruiting
- Encino Research Center- Site Number : 8400033
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La Mesa, California, United States, 91942
- Recruiting
- Paradigm Clinical Research Centers- Site Number : 8400064
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Lafayette, California, United States, 94549
- Recruiting
- Sunwise Clinical Research- Site Number : 8400108
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Lancaster, California, United States, 93534
- Recruiting
- Chemidox Clinical Trials- Site Number : 8400075
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Los Angeles, California, United States, 90027
- Recruiting
- Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400058
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Los Angeles, California, United States, 90057
- Recruiting
- LA Universal Research Center- Site Number : 8400059
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Los Angeles, California, United States, 91307
- Recruiting
- Alliance Clinical - West Hills- Site Number : 8400131
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North Hollywood, California, United States, 91606
- Recruiting
- Carbon Health - North Hollywood - NoHo West- Site Number : 8400076
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Northridge, California, United States, 91325
- Recruiting
- Northridge Clinical Trials - Northridge- Site Number : 8400053
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Oceanside, California, United States, 92056
- Recruiting
- Profound Research - Dermatologist Medical Group of North County- Site Number : 8400099
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Oxnard, California, United States, 93030
- Recruiting
- Cura Clinical Research - Oxnard- Site Number : 8400062
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Palmdale, California, United States, 93551
- Recruiting
- Amicis Research Center, LLC- Site Number : 8400110
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Pomona, California, United States, 91767
- Recruiting
- Empire Clinical Research - Pomona- Site Number : 8400055
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Rolling Hills Estates, California, United States, 90274
- Recruiting
- Peninsula Research Associates- Site Number : 8400102
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San Diego, California, United States, 92123
- Recruiting
- California Research Foundation- Site Number : 8400095
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San Diego, California, United States, 92103
- Recruiting
- Artemis Institute for Clinical Research - San Diego - Washington Street- Site Number : 8400103
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Santa Rosa, California, United States, 95405
- Recruiting
- NorthBay Clinical Research- Site Number : 8400066
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Florida
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Boynton Beach, Florida, United States, 33436
- Recruiting
- Encore Medical Research of Boynton Beach- Site Number : 8400116
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Coral Gables, Florida, United States, 33134
- Recruiting
- Driven Research- Site Number : 8400135
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Coral Gables, Florida, United States, 33134
- Recruiting
- Universal Medical Research - Coral Gables- Site Number : 8400081
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Coral Gables, Florida, United States, 33134
- Recruiting
- HealthMed Clinical Center- Site Number : 8400071
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Cutler Bay, Florida, United States, 33157
- Recruiting
- Genomics Medical Research- Site Number : 8400120
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Hialeah, Florida, United States, 33012
- Recruiting
- Direct Helpers Research Center- Site Number : 8400118
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Hollywood, Florida, United States, 33021
- Recruiting
- Zenith Clinical Research- Site Number : 8400127
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Hollywood, Florida, United States, 33024
- Recruiting
- Encore Medical Research - Hollywood- Site Number : 8400122
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Homestead, Florida, United States, 33030
- Recruiting
- Universal Medical and Research Center- Site Number : 8400079
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Jacksonville, Florida, United States, 32216
- Recruiting
- Encore Research Group-Jacksonville Center for Clinical Research- Site Number : 8400006
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Lady Lake, Florida, United States, 32159
- Recruiting
- K2 Medical Research - The Villages - Northeast 138th Lane- Site Number : 8400063
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Miami, Florida, United States, 33126
- Recruiting
- Dr. Manuel J Hernandez Clinical Research and Associates, Inc.- Site Number : 8400106
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Miami, Florida, United States, 33136
- Recruiting
- SouthCoast Research Center- Site Number : 8400114
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Miami, Florida, United States, 33174
- Recruiting
- Advanced Medical Research Institute - Miami- Site Number : 8400100
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Miami, Florida, United States, 33176
- Recruiting
- WellQuest Clinical- Site Number : 8400082
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Miami, Florida, United States, 33176
- Recruiting
- Health and Life Research Institute- Site Number : 8400070
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Ocala, Florida, United States, 34470
- Recruiting
- Renstar Medical Research - Ocala - Northeast 1st Avenue- Site Number : 8400021
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Plantation, Florida, United States, 33317
- Recruiting
- Leading Edge Dermatology- Site Number : 8400077
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Pompano Beach, Florida, United States, 33060
- Recruiting
- Nuline Clinical Trial Center- Site Number : 8400060
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Tamarac, Florida, United States, 33321
- Recruiting
- D&H Tamarac Research Center- Site Number : 8400121
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Tampa, Florida, United States, 33609
- Recruiting
- TrueBlue Clinical Research- Site Number : 8400016
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Tampa, Florida, United States, 33612
- Recruiting
- Optimum Clinical Trial Group- Site Number : 8400125
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Tampa, Florida, United States, 33613
- Recruiting
- CenExel FCR Tampa- Site Number : 8400130
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Georgia
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Decatur, Georgia, United States, 30030
- Recruiting
- Accel Research Sites - NeuroStudies- Site Number : 8400134
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Illinois
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Chicago, Illinois, United States, 60614
- Recruiting
- MetroMed Clinical Trials- Site Number : 8400054
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Oak Brook, Illinois, United States, 60523
- Recruiting
- AMR Chicago- Site Number : 8400019
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Skokie, Illinois, United States, 60077
- Recruiting
- NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400031
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Indiana
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Indianapolis, Indiana, United States, 46256
- Recruiting
- Dawes Fretzin Clinical Research- Site Number : 8400022
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Iowa
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Ames, Iowa, United States, 50010
- Recruiting
- Accellacare - McFarland Clinic- Site Number : 8400045
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West Des Moines, Iowa, United States, 50266
- Recruiting
- The Iowa Clinic West Des Moines Campus- Site Number : 8400084
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Kentucky
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Bowling Green, Kentucky, United States, 42104
- Recruiting
- Equity Medical - Bowling Green- Site Number : 8400093
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Louisiana
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Baton Rouge, Louisiana, United States, 70809
- Recruiting
- Louisiana Dermatology Associates- Site Number : 8400043
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Metairie, Louisiana, United States, 70006
- Recruiting
- Clinical Trials Management - Metairie- Site Number : 8400072
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New Orleans, Louisiana, United States, 70115
- Recruiting
- DelRicht Research - New Orleans 308- Site Number : 8400013
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Maryland
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Rockville, Maryland, United States, 20850
- Recruiting
- Private Practice - Dr. Lawrence J. Green- Site Number : 8400024
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Massachusetts
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Brighton, Massachusetts, United States, 02135
- Recruiting
- MetroBoston Clinical Partners - Brighton- Site Number : 8400008
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Marlborough, Massachusetts, United States, 01752
- Recruiting
- Kuchnir Dermatology & Dermatologic Surgery- Site Number : 8400096
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Michigan
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Allen Park, Michigan, United States, 48101
- Recruiting
- Michigan Institute of Research- Site Number : 8400092
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Dearborn Heights, Michigan, United States, 48127
- Recruiting
- Vida Clinical Studies - Dearborn Heights- Site Number : 8400074
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Minnesota
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Minneapolis, Minnesota, United States, 55402
- Recruiting
- Clinical Research Institute - Minneapolis- Site Number : 8400080
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Missouri
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Saint Joseph, Missouri, United States, 64506
- Recruiting
- MediSearch Clinical Trials- Site Number : 8400035
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Montana
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Missoula, Montana, United States, 59804
- Recruiting
- Boeson Research - Missoula- Site Number : 8400069
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Nevada
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Las Vegas, Nevada, United States, 89030
- Recruiting
- Las Vegas Clinical Trials- Site Number : 8400056
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North Carolina
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Wilmington, North Carolina, United States, 28403
- Recruiting
- Trial Management Associates - Wilmington - Floral Parkway- Site Number : 8400104
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
- Recruiting
- Lynn Institute of Oklahoma City- Site Number : 8400004
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Pennsylvania
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Camp Hill, Pennsylvania, United States, 17011
- Recruiting
- Best Skin Research - Camp Hill- Site Number : 8400017
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South Carolina
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Mt. Pleasant, South Carolina, United States, 29464
- Recruiting
- Delricht Research - Mt Pleasant Dermatology- Site Number : 8400047
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Tennessee
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Smyrna, Tennessee, United States, 37167
- Recruiting
- DelRicht Research - Thompson's Station- Site Number : 8400041
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Texas
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Baytown, Texas, United States, 77521
- Recruiting
- Inquest Clinical Research - Baytown - West Baker Road- Site Number : 8400115
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Carrollton, Texas, United States, 75010
- Recruiting
- DFW Clinical Trials- Site Number : 8400057
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Dallas, Texas, United States, 75231
- Recruiting
- Modern Research Associates- Site Number : 8400094
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Houston, Texas, United States, 77004
- Recruiting
- Center for Clinical Studies - Houston - Binz Street- Site Number : 8400002
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Katy, Texas, United States, 77450
- Recruiting
- Lone Star Clinical Research - Katy- Site Number : 8400049
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Prosper, Texas, United States, 75078
- Recruiting
- DelRicht Research - Lockhart Matter Dermatology & Aesthetic Center- Site Number : 8400046
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Utah
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Bountiful, Utah, United States, 84010
- Recruiting
- Cope Family Medicine - Ogden Clinic- Site Number : 8400112
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Layton, Utah, United States, 84041
- Recruiting
- Alpine Research Association- Site Number : 8400050
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Salt Lake City, Utah, United States, 84107
- Recruiting
- CenExel JRB - Salth Lake City- Site Number : 8400128
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Springville, Utah, United States, 84663
- Recruiting
- Springville Dermatology - Springville- Site Number : 8400113
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Virginia
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Lynchburg, Virginia, United States, 24501
- Recruiting
- The Education & Research Foundation- Site Number : 8400036
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Washington
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Seattle, Washington, United States, 98104
- Recruiting
- Seattle Clinical Research Center- Site Number : 8400038
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within 6 months prior to the first study intervention administration; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Known systemic hypersensitivity to any of the study intervention components; history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA coronavirus disease 2019 (COVID-19) vaccine
- Active nodulocystic acne, acne conglobate, acne fulminans, secondary acne (eg, chloracne, drug-induced acne) or other forms of acne (eg, acne mechanica)
- Use of any acne-affecting treatment without an appropriate washout period
- Receipt of any vaccine (other than the study vaccine) in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine (other than the study vaccine) in the 4 weeks following any study intervention administration
- Previous vaccination against C. acnes with an investigational vaccine
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Self-reported or documented seropositivity for human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sentinel Cohort A - Experimental
Two administrations of the Acne mRNA vaccine will be injected in three increasing doses
|
Pharmaceutical form: Liquid suspension for injection Route of administration: intramuscular
|
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Placebo Comparator: Sentinel Cohort A - Placebo
Two administrations of placebo will be injected
|
Pharmaceutical form: Liquid solution for injection Route of administration: intramuscular
|
|
Experimental: Sentinel Cohort B - Experimental
Three administrations of the Acne mRNA vaccine will be injected in two increasing doses
|
Pharmaceutical form: Liquid suspension for injection Route of administration: intramuscular
|
|
Placebo Comparator: Sentinel Cohort B - Placebo
Three administrations of placebo will be injected
|
Pharmaceutical form: Liquid solution for injection Route of administration: intramuscular
|
|
Experimental: Main Cohort A - Experimental
Two administrations of the Acne mRNA vaccine will be injected in three increasing doses
|
Pharmaceutical form: Liquid suspension for injection Route of administration: intramuscular
|
|
Placebo Comparator: Main Cohort A - Placebo
Two administrations of placebo will be injected
|
Pharmaceutical form: Liquid solution for injection Route of administration: intramuscular
|
|
Experimental: Main Cohort B - Experimental
Three administrations of the Acne mRNA vaccine will be injected in two increasing doses
|
Pharmaceutical form: Liquid suspension for injection Route of administration: intramuscular
|
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Placebo Comparator: Main Cohort B - Placebo
Three administrations of placebo will be injected
|
Pharmaceutical form: Liquid solution for injection Route of administration: intramuscular
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited systemic AEs
Time Frame: 30 minutes after each administration
|
Presence of unsolicited systemic adverse events (AEs) reported
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30 minutes after each administration
|
|
Core Study - Sentinel Cohorts A and B: Number of participants with solicited injection site and systemic reactions
Time Frame: Up to 7 days after each administration
|
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant diary [PDi] and in the case report form [CRF])
|
Up to 7 days after each administration
|
|
Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited AEs
Time Frame: Up to 28 days after each administration
|
Up to 28 days after each administration
|
|
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Core Study - Sentinel Cohorts A and B: Number of participants with MAAEs
Time Frame: Up to 6 months after each administration
|
Presence of medically attended adverse events (MAAEs)
|
Up to 6 months after each administration
|
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Core Study - Sentinel Cohorts A and B: Number of participants with SAEs
Time Frame: Up to 6 months after each administration
|
Presence of all serious adverse events (SAEs)
|
Up to 6 months after each administration
|
|
Core Study - Sentinel Cohorts A and B: Number of participants with AESIs
Time Frame: Up to 6 months after each administration
|
Presence of AEs of special interest (AESIs)
|
Up to 6 months after each administration
|
|
Core Study - Sentinel Cohorts A and B: Number of participants with out-of-range biological test results (including shift from baseline values)
Time Frame: Through 7 days after administration (Day 8)
|
Through 7 days after administration (Day 8)
|
|
|
Core Study - Main Cohort A: Percentage change from baseline (Day 1) in the number of inflammatory acne lesions on face
Time Frame: At 2 months post last administration
|
At 2 months post last administration
|
|
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Core Study - Main Cohort A: Percentage change from baseline (Day 1) in the number of non-inflammatory acne lesions on face
Time Frame: At 2 months post last administration
|
At 2 months post last administration
|
|
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Core Study - Main Cohort B: Percentage change from baseline (Day 1) in the total number of acne lesions on face at
Time Frame: At 2 months post last administration
|
At 2 months post last administration
|
|
|
Long-Term Extension - Sentinel Cohorts A, B and Main Cohort: Number of participants with SAEs and AESIs
Time Frame: Up to 38 or 40 months after first administration
|
Presence of all serious adverse events (SAEs) and adverse events of special interest (AESIs)
|
Up to 38 or 40 months after first administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Core Study - Sentinel Cohorts A, B and Main Cohorts A and B: Assessment of accine-antigen-specific serum antibody titers
Time Frame: From baseline (Day 1) to 6 months post last administration
|
From baseline (Day 1) to 6 months post last administration
|
|
|
Core Study - Main Cohort B: Absolute change from baseline (Day 1) in the total number of inflammatory acne lesions on face
Time Frame: At 1 month post first administration until 9 months post last administration
|
At 1 month post first administration until 9 months post last administration
|
|
|
Core Study - Main Cohorts A and B: Percentage change from baseline (Day 1) in the number of inflammatory acne lesions on face
Time Frame: At 1 month post first administration until 6 or 9 months post last administration
|
At 1 month post first administration until 6 or 9 months post last administration
|
|
|
Core Study - Main Cohorts A and B: Absolute change from baseline (Day 1) in the number of non-inflammatory acne lesions on face
Time Frame: At 1 month post first administration until 6 or 9 months post last administration
|
At 1 month post first administration until 6 or 9 months post last administration
|
|
|
Core Study - Main Cohorts A and B: Absolute change from baseline in IGA score
Time Frame: At 1 month post first administration until 6 or 9 months post last administration
|
At 1 month post first administration until 6 or 9 months post last administration
|
|
|
Core Study - Main Cohorts A and B: Number of participants with unsolicited systemic AEs
Time Frame: 30 minutes after each administration
|
Presence of unsolicited systemic adverse events (AEs) reported
|
30 minutes after each administration
|
|
Core Study - Main Cohorts A and B: Number of participants with solicited injection site and systemic reactions
Time Frame: Up to 7 days after each administration
|
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant diary [PDi] and in the case report form [CRF])
|
Up to 7 days after each administration
|
|
Core Study - Main Cohorts A and B: Number of participants with unsolicited AEs
Time Frame: Up to 28 days after each administration
|
Up to 28 days after each administration
|
|
|
Core Study - Main Cohorts A and B: Number of participants with MAAEs
Time Frame: Up to 6 or 9 months after each administration
|
Presence of medically attended adverse events (MAAEs)
|
Up to 6 or 9 months after each administration
|
|
Core Study - Main Cohorts A and B: Number of participants with SAEs
Time Frame: Up to 6 or 9 months after each administration
|
Presence of all serious adverse events (SAEs)
|
Up to 6 or 9 months after each administration
|
|
Core Study - Main Cohorts A and B: Number of participants with AESIs
Time Frame: Up to 6 or 9 months after each administration
|
Presence of AEs of special interest (AESIs)
|
Up to 6 or 9 months after each administration
|
|
Core Study - Main Cohorts A and B: Number of participants with out-of-range biological test results (including shift from baseline values)
Time Frame: Up to 7 days after each administration
|
Up to 7 days after each administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 5, 2024
Primary Completion (Estimated)
November 30, 2028
Study Completion (Estimated)
November 30, 2028
Study Registration Dates
First Submitted
March 12, 2024
First Submitted That Met QC Criteria
March 12, 2024
First Posted (Actual)
March 18, 2024
Study Record Updates
Last Update Posted (Actual)
August 21, 2026
Last Update Submitted That Met QC Criteria
August 19, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VBE00001
- 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- U1111-1295-3154 (Registry Identifier: ICTRP)
- 2025-521740-38 (Registry Identifier: CTIS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications.
Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.