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

Condition studied

Acne

Investigational medicinal product(s)

Every trial of Acne mRNA vaccine across our registers →

Eligibility

Primary endpoint

Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited systemic AEs, Core Study - Sentinel Cohorts A and B: Number of participants with solicited injection site and systemic reactions, Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited AEs, Core Study - Sentinel Cohorts A and B: Number of participants with MAAEs, Core Study - Sentinel Cohorts A and B: Number of patients with SAEs, Core Study - Sentinel Cohorts A and B: Number of participants with AESIs, Core Study - Sentinel Cohorts A and B: Number of participants with out-of-range biological test results (including shift from baseline values), Core Study - Main Cohort A: Percentage change from baseline (Day 1) in the number of inflammatory acne lesions on face, Core Study - Main Cohort A: Percentage change from baseline (Day 1) in the number of non-inflammatory acne lesions on face, Core Study – Main Cohort B: Percentage change from baseline (Day 1) in the total number of acne lesions on face at, Long-Term Extension – Sentinel Cohorts A, B and Main Cohort: Number of participants with SAEs and AESIs

Endpoint detail

Core Study - Sentinel Cohorts A, B and Main Cohorts A and B: Assessment of vaccine-antigen-specific serum antibody titers, Core Study - Main Cohort A and B: Absolute and percentage change from baseline (Day 1) in the total number of acne lesions on face, Core Study - Main Cohorts A and B: Absolute and percentage change from baseline (Day 1) in the number of inflammatory acne lesions on face, Core Study - Main Cohorts A and B: Absolute change from baseline (Day 1) in the number of non-inflammatory acne lesions on face, Core Study - Main Cohorts: Absolute change from baseline in IGA score, Core Study - Main Cohorts A and B: Number of participants with unsolicited systemic AEs, Core Study - Main Cohorts A and B: Number of participants with solicited injection site and systemic reactions, Core Study - Main Cohorts A and B: Number of participants with unsolicited AEs, Core Study - Main Cohorts A and B: Number of participants with MAAEs, Core Study - Main Cohorts A and B: Number of participants with SAEs, Core Study - Main Cohorts A and B: Number of participants with AESIs, Cores Study - Main Cohorts A and B: Number of participants with out-of-range biological test results (including shift from baseline values)