Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris

• Status: Recruiting
• Trial end date: 2023-02-13
• Target enrollment: 0
• Participant gender: All

Summary

This trial investigates the safety and tolerability of three different doses and two types of administration routes of a C. acnes vaccine (ORI-A-ce001) in subjects with acne vulgaris.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Origimm Biotechnology GmbH

Criteria

Inclusion Criteria:

• Male or female subject aged ≥18 years at the time of informed consent signature

• Female subjects of childbearing potential must have a negative serum or urine pregnancy test at Screening and before vaccination and must be willing to practice a highly effective method of contraception during the study

• Subject with a clinical diagnosis of moderate facial acne vulgaris (grade 3 on a 5-grade IGA scale) at Baseline Visit

• Subject must have a maximum of 40 non-inflammatory acne lesions (open and closed comedones) and between a minimum of 20 and a maximum of 70 inflammatory acne lesions (papules and pustules) and a maximum of 1 nodulocystic lesion (nodules and cysts) on the face (e.g., forehead, nose, cheeks, chin, upper lip) at Baseline Visit

• Negative Covid test at Baseline Visit

Exclusion Criteria:

• Subject who is pregnant, lactating or is planning a pregnancy during the study period

• Subject who has active nodulocystic acne, acne conglobata, acne fulminans, secondary acne or other forms of acne

• Subject who has more than one facial nodules/cysts (where nodule/cyst is defined as an inflammatory lesion greater than or equal to 0.5 cm in size with or without cystic changes)

• Subject who has any skin pathology or condition that, in the Investigator's opinion, could interfere with the evaluation of the IMP (Investigational Medicinal Product) or requires use of interfering topical, systemic, or surgical therapy

• Subject with excessive facial hair, facial skin disorders, skin reactions that may interfere with the study assessments in the Investigator's opinion or skin infection

• History of Guillain-Barré-Syndrome

• Subject who has used any acne-affecting treatment without an appropriate washout period

• Subject who receives active or passive vaccination within 30 days prior to Baseline Visit Initiation or change of hormonal contraceptive use within 12 weeks prior to Screening Visit