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Acne mRNA vaccine

Phase 1

Acne | Monoclonal antibody | Dermatology |Sanofi|Last Updated: May 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment920
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07013747Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild AcnePHASE1 RECRUITING 120 — — Jul 3, 2025Jun 19, 2029Sep 5, 20254 United States
NCT06316297Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe AcnePHASE1 RECRUITING 800 — — Apr 5, 2024Nov 30, 2028May 5, 202693 United States, Australia +1
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Study Endpoints
Primary Endpoints
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited systemic adverse events (AEs)
In 30 minutes after each administration
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with solicited injection site and systemic reactions
Up to 7 days after each administration

pre-listed in the participant diary \[PDi\] and in the case report form \[CRF\]

Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited AEs reported
Up to 28 days after each administration
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with medically attended adverse events (MAAEs)
Up to 6 months after each administration
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with AEs of special interest (AESIs)
Up to 6 months after each administration
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with serious AEs (SAEs)
Up to 6 months after each administration

Presence of all SAEs

Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with out-of-range biological test results
Through 7 days after administration (Day 08)

Presence of out-of-range biological test results (including shift from baseline values)

Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of inflammatory acne lesions on face
At 2 months post last administration
Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of non-inflammatory acne lesions on face
At 2 months post last administration
Long-Term Extension - Sentinel and Main Cohort Arm 1 and 2: Number of participants with serious adverse events (SAEs) and adverse events of special interest (AESIs)
Up to 38 months after first administration

Presence of all SAEs and AESIs

Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited systemic AEs
30 minutes after each administration

Presence of unsolicited systemic adverse events (AEs) reported

Core Study - Sentinel Cohorts A and B: Number of participants with solicited injection site and systemic reactions
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 \[CRF\])

Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited AEs
Up to 28 days after each administration
Core Study - Sentinel Cohorts A and B: Number of participants with MAAEs
Up to 6 months after each administration

Presence of medically attended adverse events (MAAEs)

Core Study - Sentinel Cohorts A and B: Number of participants with SAEs
Up to 6 months after each administration

Presence of all serious adverse events (SAEs)

Core Study - Sentinel Cohorts A and B: Number of participants with AESIs
Up to 6 months after each administration

Presence of AEs of special interest (AESIs)

Core Study - Sentinel Cohorts A and B: Number of participants with out-of-range biological test results (including shift from baseline values)
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
At 2 months post last administration
Core Study - Main Cohort A: Percentage change from baseline (Day 1) in the number of non-inflammatory acne lesions on face
At 2 months post last administration
Core Study - Main Cohort B: Percentage change from baseline (Day 1) in the total number of acne lesions on face at
At 2 months post last administration
Long-Term Extension - Sentinel Cohorts A, B and Main Cohort: Number of participants with SAEs and AESIs
Up to 38 or 40 months after first administration

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

Secondary Endpoints
Core Study - Sentinel and Main Cohort Arm 1 and 2: Vaccine-antigen-specific serum antibody titers
From baseline (Day 01) to 6 months post last administration
Core Study - Main Cohort Arm 1 and 2: Absolute change from baseline (Day 01) in the number of inflammatory acne lesions on face
At 1 month post first administration to 6 months post last administration
Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of inflammatory acne lesions on face
At 1 month post first administration to 6 months post last administration
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Sentinel Cohort Arm 1EXPERIMENTALParticipants will receive 2 Acne mRNA Vaccine injections
Sentinel Cohort Arm 2PLACEBO_COMPARATORParticipants will receive 2 Placebo injections
Main Cohort Arm 1EXPERIMENTALParticipants will receive 2 Acne mRNA Vaccine injections
Main Cohort Arm 2PLACEBO_COMPARATORParticipants will receive 2 Placebo injections
Sentinel Cohort A - ExperimentalEXPERIMENTALTwo administrations of the Acne mRNA vaccine will be injected in three increasing doses
Sentinel Cohort A - PlaceboPLACEBO_COMPARATORTwo administrations of placebo will be injected
Sentinel Cohort B - ExperimentalEXPERIMENTALThree administrations of the Acne mRNA vaccine will be injected in two increasing doses
Sentinel Cohort B - PlaceboPLACEBO_COMPARATORThree administrations of placebo will be injected
Main Cohort A - ExperimentalEXPERIMENTALTwo administrations of the Acne mRNA vaccine will be injected in three increasing doses
Main Cohort A - PlaceboPLACEBO_COMPARATORTwo administrations of placebo will be injected
Main Cohort B - ExperimentalEXPERIMENTALThree administrations of the Acne mRNA vaccine will be injected in two increasing doses
Main Cohort B - PlaceboPLACEBO_COMPARATORThree administrations of placebo will be injected
Interventions
NameTypeDescription
Acne mRNA vaccineBIOLOGICALPharmaceutical form: suspension for injection Route of administration: intramuscular
PlaceboOTHERPharmaceutical form: liquid solution for injection Route of administration: intramuscular
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersNo
Study Sites4

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 mild facial acne vulgaris with: * IGA score of mild (grade 2 on the 5-grade I...

Countries:United StatesAustraliaCanada
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Competitive Landscape -Acne 12 trials
CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV1PHASE3Undisclosed
Biofrontera, Inc.BFRI1PHASE21h Incubation Photodynamic therapy, 3h Incubation Photodynamic therapy
Sanofi SA Sponsored ADRSNY3PHASE1Acne mRNA vaccine
Hoth Therapeutics, Inc.HOTH1PHASE2HT-001 2%, HT-001 1%, HT-001 0.5%
Sagimet Biosciences Inc. Class ASGMT1PHASE1TVB-3567
Bausch Health Companies Inc.BHC1 — clindamycin , adapalene and benzoyl peroxide
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06316297Enrollment: 260 → 800
LOWMay 26, 2026NCT07013747primaryCompletionDate: changed
LOWMay 24, 2026NCT06316297studyFirstPostDate: changed
LOWMay 24, 2026NCT07013747studyFirstPostDate: changed