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AcnePhase 1/2NCT06316297

Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne

A Phase 1/2 study testing Acne mRNA vaccine in people with Acne, run by Sanofi Pasteur, a Sanofi Company at 94 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 four dose levels in adult participants aged 18 to 45 years with moderate to severe acne. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Acne
What is being tested?
Acne mRNA vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
800 participants
Where
94 sitesin 4 countries
Study dates
5 Apr 2024to 30 Nov 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

94 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Trial Transparency email recommended (Toll free for US & Canada) contact

800-633-1610 ext. option 6

contact-us@sanofi.com

94 sites in 4 countries

United States79 sites, 79 recruiting

  • Michigan Institute of Research- Site Number : 8400092

    Allen Park, Michigan, 48101

    Recruiting

  • Accellacare - McFarland Clinic- Site Number : 8400045

    Ames, Iowa, 50010

    Recruiting

  • Louisiana Dermatology Associates- Site Number : 8400043

    Baton Rouge, Louisiana, 70809

    Recruiting

  • Inquest Clinical Research - Baytown - West Baker Road- Site Number : 8400115

    Baytown, Texas, 77521

    Recruiting

  • Cope Family Medicine - Ogden Clinic- Site Number : 8400112

    Bountiful, Utah, 84010

    Recruiting

  • Equity Medical - Bowling Green- Site Number : 8400093

    Bowling Green, Kentucky, 42104

    Recruiting

  • Encore Medical Research of Boynton Beach- Site Number : 8400116

    Boynton Beach, Florida, 33436

    Recruiting

  • MetroBoston Clinical Partners - Brighton- Site Number : 8400008

    Brighton, Massachusetts, 02135

    Recruiting

  • Best Skin Research - Camp Hill- Site Number : 8400017

    Camp Hill, Pennsylvania, 17011

    Recruiting

  • DFW Clinical Trials- Site Number : 8400057

    Carrollton, Texas, 75010

    Recruiting

  • Private Practice - Dr. Francisco Badar- Site Number : 8400067

    Cerritos, California, 90703

    Recruiting

  • MetroMed Clinical Trials- Site Number : 8400054

    Chicago, Illinois, 60614

    Recruiting

  • Driven Research- Site Number : 8400135

    Coral Gables, Florida, 33134

    Recruiting

  • HealthMed Clinical Center- Site Number : 8400071

    Coral Gables, Florida, 33134

    Recruiting

  • Universal Medical Research - Coral Gables- Site Number : 8400081

    Coral Gables, Florida, 33134

    Recruiting

  • Genomics Medical Research- Site Number : 8400120

    Cutler Bay, Florida, 33157

    Recruiting

  • Modern Research Associates- Site Number : 8400094

    Dallas, Texas, 75231

    Recruiting

  • Vida Clinical Studies - Dearborn Heights- Site Number : 8400074

    Dearborn Heights, Michigan, 48127

    Recruiting

  • Accel Research Sites - NeuroStudies- Site Number : 8400134

    Decatur, Georgia, 30030

    Recruiting

  • Encino Research Center- Site Number : 8400033

    Encino, California, 91436

    Recruiting

  • Direct Helpers Research Center- Site Number : 8400118

    Hialeah, Florida, 33012

    Recruiting

  • Zenith Clinical Research- Site Number : 8400127

    Hollywood, Florida, 33021

    Recruiting

  • Encore Medical Research - Hollywood- Site Number : 8400122

    Hollywood, Florida, 33024

    Recruiting

  • Universal Medical and Research Center- Site Number : 8400079

    Homestead, Florida, 33030

    Recruiting

  • Center for Clinical Studies - Houston - Binz Street- Site Number : 8400002

    Houston, Texas, 77004

    Recruiting

  • Dawes Fretzin Clinical Research- Site Number : 8400022

    Indianapolis, Indiana, 46256

    Recruiting

  • Encore Research Group-Jacksonville Center for Clinical Research- Site Number : 8400006

    Jacksonville, Florida, 32216

    Recruiting

  • Lone Star Clinical Research - Katy- Site Number : 8400049

    Katy, Texas, 77450

    Recruiting

  • Paradigm Clinical Research Centers- Site Number : 8400064

    La Mesa, California, 91942

    Recruiting

  • K2 Medical Research - The Villages - Northeast 138th Lane- Site Number : 8400063

    Lady Lake, Florida, 32159

    Recruiting

  • Sunwise Clinical Research- Site Number : 8400108

    Lafayette, California, 94549

    Recruiting

  • Chemidox Clinical Trials- Site Number : 8400075

    Lancaster, California, 93534

    Recruiting

  • Las Vegas Clinical Trials- Site Number : 8400056

    Las Vegas, Nevada, 89030

    Recruiting

  • Alpine Research Association- Site Number : 8400050

    Layton, Utah, 84041

    Recruiting

  • Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400058

    Los Angeles, California, 90027

    Recruiting

  • LA Universal Research Center- Site Number : 8400059

    Los Angeles, California, 90057

    Recruiting

  • Alliance Clinical - West Hills- Site Number : 8400131

    Los Angeles, California, 91307

    Recruiting

  • The Education & Research Foundation- Site Number : 8400036

    Lynchburg, Virginia, 24501

    Recruiting

  • Kuchnir Dermatology & Dermatologic Surgery- Site Number : 8400096

    Marlborough, Massachusetts, 01752

    Recruiting

  • Clinical Trials Management - Metairie- Site Number : 8400072

    Metairie, Louisiana, 70006

    Recruiting

  • Dr. Manuel J Hernandez Clinical Research and Associates, Inc.- Site Number : 8400106

    Miami, Florida, 33126

    Recruiting

  • SouthCoast Research Center- Site Number : 8400114

    Miami, Florida, 33136

    Recruiting

  • Advanced Medical Research Institute - Miami- Site Number : 8400100

    Miami, Florida, 33174

    Recruiting

  • Health and Life Research Institute- Site Number : 8400070

    Miami, Florida, 33176

    Recruiting

  • WellQuest Clinical- Site Number : 8400082

    Miami, Florida, 33176

    Recruiting

  • Clinical Research Institute - Minneapolis- Site Number : 8400080

    Minneapolis, Minnesota, 55402

    Recruiting

  • Boeson Research - Missoula- Site Number : 8400069

    Missoula, Montana, 59804

    Recruiting

  • Delricht Research - Mt Pleasant Dermatology- Site Number : 8400047

    Mt. Pleasant, South Carolina, 29464

    Recruiting

  • DelRicht Research - New Orleans 308- Site Number : 8400013

    New Orleans, Louisiana, 70115

    Recruiting

  • Carbon Health - North Hollywood - NoHo West- Site Number : 8400076

    North Hollywood, California, 91606

    Recruiting

  • Northridge Clinical Trials - Northridge- Site Number : 8400053

    Northridge, California, 91325

    Recruiting

  • AMR Chicago- Site Number : 8400019

    Oak Brook, Illinois, 60523

    Recruiting

  • Renstar Medical Research - Ocala - Northeast 1st Avenue- Site Number : 8400021

    Ocala, Florida, 34470

    Recruiting

  • Profound Research - Dermatologist Medical Group of North County- Site Number : 8400099

    Oceanside, California, 92056

    Recruiting

  • Lynn Institute of Oklahoma City- Site Number : 8400004

    Oklahoma City, Oklahoma, 73112

    Recruiting

  • Cura Clinical Research - Oxnard- Site Number : 8400062

    Oxnard, California, 93030

    Recruiting

  • Amicis Research Center, LLC- Site Number : 8400110

    Palmdale, California, 93551

    Recruiting

  • Leading Edge Dermatology- Site Number : 8400077

    Plantation, Florida, 33317

    Recruiting

  • Empire Clinical Research - Pomona- Site Number : 8400055

    Pomona, California, 91767

    Recruiting

  • Nuline Clinical Trial Center- Site Number : 8400060

    Pompano Beach, Florida, 33060

    Recruiting

  • DelRicht Research - Lockhart Matter Dermatology & Aesthetic Center- Site Number : 8400046

    Prosper, Texas, 75078

    Recruiting

  • Private Practice - Dr. Lawrence J. Green- Site Number : 8400024

    Rockville, Maryland, 20850

    Recruiting

  • Peninsula Research Associates- Site Number : 8400102

    Rolling Hills Estates, California, 90274

    Recruiting

  • MediSearch Clinical Trials- Site Number : 8400035

    Saint Joseph, Missouri, 64506

    Recruiting

  • CenExel JRB - Salth Lake City- Site Number : 8400128

    Salt Lake City, Utah, 84107

    Recruiting

  • Artemis Institute for Clinical Research - San Diego - Washington Street- Site Number : 8400103

    San Diego, California, 92103

    Recruiting

  • California Research Foundation- Site Number : 8400095

    San Diego, California, 92123

    Recruiting

  • NorthBay Clinical Research- Site Number : 8400066

    Santa Rosa, California, 95405

    Recruiting

  • Center for Dermatology and Plastic Surgery- Site Number : 8400111

    Scottsdale, Arizona, 85260

    Recruiting

  • Seattle Clinical Research Center- Site Number : 8400038

    Seattle, Washington, 98104

    Recruiting

  • NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400031

    Skokie, Illinois, 60077

    Recruiting

  • DelRicht Research - Thompson's Station- Site Number : 8400041

    Smyrna, Tennessee, 37167

    Recruiting

  • Springville Dermatology - Springville- Site Number : 8400113

    Springville, Utah, 84663

    Recruiting

  • D&H Tamarac Research Center- Site Number : 8400121

    Tamarac, Florida, 33321

    Recruiting

  • TrueBlue Clinical Research- Site Number : 8400016

    Tampa, Florida, 33609

    Recruiting

  • Optimum Clinical Trial Group- Site Number : 8400125

    Tampa, Florida, 33612

    Recruiting

  • CenExel FCR Tampa- Site Number : 8400130

    Tampa, Florida, 33613

    Recruiting

  • The Iowa Clinic West Des Moines Campus- Site Number : 8400084

    West Des Moines, Iowa, 50266

    Recruiting

  • Trial Management Associates - Wilmington - Floral Parkway- Site Number : 8400104

    Wilmington, North Carolina, 28403

    Recruiting

Other trials in United States

Australia8 sites, 8 recruiting

  • Investigational Site Number : 0360007

    Carlton, Victoria, 3053

    Recruiting

  • Investigational Site Number : 0360008

    Kotara, New South Wales, 2289

    Recruiting

  • Investigational Site Number : 0360002

    Melbourne, Victoria, 3004

    Recruiting

  • Investigational Site Number : 0360009

    Melbourne, Victoria, 3124

    Recruiting

  • Investigational Site Number : 0360001

    Phillip, Australian Capital Territory, 2606

    Recruiting

  • Investigational Site Number : 0360003

    Sydney, New South Wales, 2010

    Recruiting

  • Investigational Site Number : 0360006

    Waitara, New South Wales, 2077

    Recruiting

  • Investigational Site Number : 0360005

    Woolloongabba, Queensland, 4102

    Recruiting

Other trials in Australia

Canada6 sites, 6 recruiting

  • Investigational Site Number : 1240001

    Barrie, Ontario, L4M 7G1

    Recruiting

  • Investigational Site Number : 1240006

    Edmonton, Alberta, T5J 3S9

    Recruiting

  • Investigational Site Number : 1240009

    Montreal, Quebec, H1Y 3L1

    Recruiting

  • Investigational Site Number : 1240007

    Québec, Quebec, G1W 4R4

    Recruiting

  • Investigational Site Number : 1240008

    Sherbrooke, Quebec, J1G 1X9

    Recruiting

  • Investigational Site Number : 1240004

    Toronto, Ontario, M4E 1R7

    Recruiting

Other trials in Canada

Puerto Rico1 site, 1 recruiting

  • Investigational Site Number : 6300002

    San Juan, 00909

    Recruiting

Other trials in Puerto Rico

About this study

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 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).

Read more

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.

Read the 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.

Conditions
Acne
Being tested
Acne mRNA vaccine, Placebo
Medical subject headings
Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acne mRNA vaccineBiological

    Pharmaceutical form: Liquid suspension for injection Route of administration: intramuscular

  • PlaceboOther

    Pharmaceutical form: Liquid solution for injection Route of administration: intramuscular

Study groups in NCT06316297
Study groupRoleWhat they receive
Sentinel Cohort A - ExperimentalExperimentalTwo administrations of the Acne mRNA vaccine will be injected in three increasing doses
Receives: Biological: Acne mRNA vaccine
Sentinel Cohort A - PlaceboPlacebo comparatorTwo administrations of placebo will be injected
Receives: Other: Placebo
Sentinel Cohort B - ExperimentalExperimentalThree administrations of the Acne mRNA vaccine will be injected in two increasing doses
Receives: Biological: Acne mRNA vaccine
Sentinel Cohort B - PlaceboPlacebo comparatorThree administrations of placebo will be injected
Receives: Other: Placebo
Main Cohort A - ExperimentalExperimentalTwo administrations of the Acne mRNA vaccine will be injected in three increasing doses
Receives: Biological: Acne mRNA vaccine
Main Cohort A - PlaceboPlacebo comparatorTwo administrations of placebo will be injected
Receives: Other: Placebo
Main Cohort B - ExperimentalExperimentalThree administrations of the Acne mRNA vaccine will be injected in two increasing doses
Receives: Biological: Acne mRNA vaccine
Main Cohort B - PlaceboPlacebo comparatorThree administrations of placebo will be injected
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited systemic AEs

    Presence of unsolicited systemic adverse events (AEs) reported

    Measured: 30 minutes after each administration

  2. Core Study - Sentinel Cohorts A and B: Number of participants with solicited injection site and systemic reactions

    Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant diary [PDi] and in the case report form [CRF])

    Measured: Up to 7 days after each administration

  3. Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited AEs

    Measured: Up to 28 days after each administration

  4. Core Study - Sentinel Cohorts A and B: Number of participants with MAAEs

    Presence of medically attended adverse events (MAAEs)

    Measured: Up to 6 months after each administration

  5. Core Study - Sentinel Cohorts A and B: Number of participants with SAEs

    Presence of all serious adverse events (SAEs)

    Measured: Up to 6 months after each administration

  6. Core Study - Sentinel Cohorts A and B: Number of participants with AESIs

    Presence of AEs of special interest (AESIs)

    Measured: Up to 6 months after each administration

  7. Core Study - Sentinel Cohorts A and B: Number of participants with out-of-range biological test results (including shift from baseline values)

    Measured: Through 7 days after administration (Day 8)

  8. Core Study - Main Cohort A: Percentage change from baseline (Day 1) in the number of inflammatory acne lesions on face

    Measured: At 2 months post last administration

  9. Core Study - Main Cohort A: Percentage change from baseline (Day 1) in the number of non-inflammatory acne lesions on face

    Measured: At 2 months post last administration

  10. Core Study - Main Cohort B: Percentage change from baseline (Day 1) in the total number of acne lesions on face at

    Measured: At 2 months post last administration

  11. Long-Term Extension - Sentinel Cohorts A, B and Main Cohort: Number of participants with SAEs and AESIs

    Presence of all serious adverse events (SAEs) and adverse events of special interest (AESIs)

    Measured: Up to 38 or 40 months after first administration

Secondary outcomes (12)

  1. Core Study - Sentinel Cohorts A, B and Main Cohorts A and B: Assessment of accine-antigen-specific serum antibody titers

    Measured: From baseline (Day 1) to 6 months post last administration

  2. Core Study - Main Cohort B: Absolute change from baseline (Day 1) in the total number of inflammatory acne lesions on face

    Measured: At 1 month post first administration until 9 months post last administration

  3. Core Study - Main Cohorts A and B: Percentage change from baseline (Day 1) in the number of inflammatory acne lesions on face

    Measured: At 1 month post first administration until 6 or 9 months post last administration

  4. Core Study - Main Cohorts A and B: Absolute change from baseline (Day 1) in the number of non-inflammatory acne lesions on face

    Measured: At 1 month post first administration until 6 or 9 months post last administration

  5. Core Study - Main Cohorts A and B: Absolute change from baseline in IGA score

    Measured: At 1 month post first administration until 6 or 9 months post last administration

  6. Core Study - Main Cohorts A and B: Number of participants with unsolicited systemic AEs

    Presence of unsolicited systemic adverse events (AEs) reported

    Measured: 30 minutes after each administration

  7. Core Study - Main Cohorts A and B: Number of participants with solicited injection site and systemic reactions

    Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant diary [PDi] and in the case report form [CRF])

    Measured: Up to 7 days after each administration

  8. Core Study - Main Cohorts A and B: Number of participants with unsolicited AEs

    Measured: Up to 28 days after each administration

  9. Core Study - Main Cohorts A and B: Number of participants with MAAEs

    Presence of medically attended adverse events (MAAEs)

    Measured: Up to 6 or 9 months after each administration

  10. Core Study - Main Cohorts A and B: Number of participants with SAEs

    Presence of all serious adverse events (SAEs)

    Measured: Up to 6 or 9 months after each administration

  11. Core Study - Main Cohorts A and B: Number of participants with AESIs

    Presence of AEs of special interest (AESIs)

    Measured: Up to 6 or 9 months after each administration

  12. Core Study - Main Cohorts A and B: Number of participants with out-of-range biological test results (including shift from baseline values)

    Measured: Up to 7 days after each administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2024
  2. Study start5 Apr 2024
  3. Primary completion30 Nov 2028 (estimated)
  4. Study completion30 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06316297
Sponsor's protocol ID
VBE00001
Other IDs
U1111-1295-3154, 2025-521740-38, 2025
Status last verified
Aug 2026
First submitted
12 Mar 2024
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Acne mRNA vaccine in people with Acne, run by Sanofi Pasteur, a Sanofi Company at 94 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States, Australia, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, contact-us@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited systemic AEs (time frame: 30 minutes after each administration). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06316297.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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