Clinical trial NCT06316297: Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Acne
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-03-18
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential and parallel design
Primary purpose: TREATMENT

Brief 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.

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 three 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.

Eligibility criteria: 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 (eg, polyethylene glycol \[PEG\], polysorbate); 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.

Primary outcomes:
measure: Sentinel Cohort A and B: Number of participants with unsolicited systemic AEs
timeFrame: 30 minutes after each administration
measure: Sentinel Cohort A and B: Number of participants with solicited injection site and systemic reactions
timeFrame: Up to 7 days after each administration
measure: Sentinel Cohort A and B: Number of participants with unsolicited AEs
timeFrame: Up to 28 days after each administration
measure: Sentinel Cohort A and B: Number of participants with MAAEs
timeFrame: Up to 6 months after each administration
measure: Sentinel Cohort A and B: Number of participants with SAEs
timeFrame: Up to 6 months after each administration
measure: Sentinel Cohort A and B: Number of participants with related SAEs, fatal SAEs and AESIs
timeFrame: Up to 6 months after each administration
measure: Sentinel Cohort A and B: Number of participants with out-of-range biological test results (including shift from baseline values)
timeFrame: Up to 7 days after each administration
measure: Main Cohort: Percentage change from baseline in the number of inflammatory acne lesions on face
timeFrame: At 2 months post last administration
measure: Main Cohort: Percentage change from baseline in the number of non-inflammatory acne lesions on face
timeFrame: At 2 months post last administration
Secondary outcomes:
measure: Sentinel Cohort A, B and Main Cohort: Vaccine-antigen-specific serum antibody titers
timeFrame: From baseline to 6 months post last administration
measure: Main Cohort: Absolute change from baseline in the number of inflammatory acne lesions on face
timeFrame: From 1 month post first administration until 6 months post last administration
measure: Main Cohort: Percentage change from baseline in the number of inflammatory acne lesions on face
timeFrame: From 1 month post first administration until 6 months post last administration
measure: Main Cohort: Absolute change from baseline in the number of non-inflammatory acne lesions on face
timeFrame: From 1 month post first administration until 6 months post last administration
measure: Main Cohort: Percentage change from baseline in the number of non-inflammatory acne lesions on face
timeFrame: From 1 month post first administration until 6 months post last administration
measure: Main Cohort: Absolute change from baseline in IGA score
timeFrame: From 1 month post first administration until 6 months post last administration
measure: Main Cohort - Number of participants with unsolicited systemic AEs
timeFrame: 30 minutes after each administration
measure: Main Cohort - Number of participants with solicited injection site and systemic reactions
timeFrame: Up to 7 days after each administration
measure: Main Cohort - Number of participants with unsolicited AEs
timeFrame: Up to 28 days after each administration
measure: Main Cohort - Number of participants with MAAEs
timeFrame: Up to 6 months after each administration
measure: Main Cohort - Number of participants with SAEs
timeFrame: Up to 6 months after each administration
measure: Main Cohort - Number of participants with related SAEs, fatal SAEs and AESIs
timeFrame: Up to approximately 38 months
measure: Main Cohort - Number of participants with out-of-range biological test results (including shift from baseline values)
timeFrame: Up to 7 days after each administration
Other outcomes:
Locations:
city: Cerritos
country: United States
facility: Core Healthcare Group- Site Number : 8400067
state: California
city: Encino
country: United States
facility: Encino Research Center- Site Number : 8400033
state: California
city: Coral Gables
country: United States
facility: Universal Medical Research-Coral Gables Office- Site Number : 8400081
state: Florida
city: Jacksonville
country: United States
facility: Encore Research Group-Jacksonville Center for Clinical Research- Site Number : 8400006
state: Florida
city: Tampa
country: United States
facility: TrueBlue Clinical Research- Site Number : 8400016
state: Florida
city: Oak Brook
country: United States
facility: AMR - Chicago- Site Number : 8400019
state: Illinois
city: Ames
country: United States
facility: Accellacare - McFarland Clinic- Site Number : 8400045
state: Iowa
city: Baton Rouge
country: United States
facility: Louisiana Dermatology Associates- Site Number : 8400043
state: Louisiana
city: New Orleans
country: United States
facility: DelRicht Research - New Orleans 308- Site Number : 8400013
state: Louisiana
city: Needham
country: United States
facility: Metro Boston Clinical Partners- Site Number : 8400008
state: Massachusetts
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials- Site Number : 8400035
state: Missouri
city: Oklahoma City
country: United States
facility: Lynn Institute of Oklahoma City- Site Number : 8400004
state: Oklahoma
city: Camp Hill
country: United States
facility: Vial Health - DermDox Dermatology- Site Number : 8400017
state: Pennsylvania
city: Charleston
country: United States
facility: DelRicht Research at MT. Pleasant Dermatology- Site Number : 8400047
state: South Carolina
city: Smyrna
country: United States
facility: DelRicht Research at Harpeth Valley Dermatology- Site Number : 8400041
state: Tennessee
city: Houston
country: United States
facility: Center for Clinical Studies - Houston - Binz Street- Site Number : 8400002
state: Texas
city: Prosper
country: United States
facility: Lockhart Matter Dermatology- Site Number : 8400046
state: Texas
city: Forest
country: United States
facility: The Education & Research Foundation- Site Number : 8400036
state: Virginia
Study officials:
References: