Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris
- Conditions
- AcneAcne Vulgaris
- Interventions
- Drug: ORG101PL - Placebo 1Drug: ORG101 - Experimental 1
- Registration Number
- NCT05131373
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
Acne vulgaris, or acne, is one of the most prevalent diseases worldwide, with skin conditions being one of the top causes of years lived with disability and non-fatal disease burden. Despite being one of the most prevalent diseases worldwide, the most widely used treatments in acne have changed little in the past 30 years. To date there is still no effective treatment that can prevent and cure this disease. The currently available acne therapies have been discovered several decades ago, and almost no progress was made in developments of novel, breakthrough treatment approaches.
The present randomized, placebo-controlled, dose escalation, Phase 1 trial (ORI-101-PAC) is intended to investigate the safety, tolerability and immunogenicity of an acne vulgaris vaccine (ORI-A-ce001) at three different dose levels in subjects aged ≥18 years suffering from moderate facial acne vulgaris who are otherwise healthy. The present study will also generate preliminary data on efficacy (inflammatory and non-inflammatory acne lesion counts, acne severity), immunogenicity and functionality of the vaccine, as well as a possible impact on skin microbiome composition. Control groups receiving placebo are included. Data from this trial will be used to inform the design of future studies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- 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
Participants are excluded from the study if any of the following criteria apply:
- 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 Investigational Medicinal Product (IMP) 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 1 ORG101PL - Placebo 1 Placebo in adjuvanted formulation will be administered in double-blind fashion in single i.m. injections Experimental 1 ORG101 - Experimental 1 C. acnes vaccine in adjuvanted formulation will be administered in double-blind fashion in 3 single increasing doses given i.m.
- Primary Outcome Measures
Name Time Method Change from the baseline in laboratory data Through study completion, an average of 9 months Clinically significant change from the baseline in laboratory data as compared to placebo
Change from the baseline in vital signs Through study completion, an average of 9 months Clinically significant change from the baseline in vital signs as compared to placebo
Incidence of solicited and unsolicited local and/or systemic adverse events (AEs) 7 days following each vaccination Number of participants with AEs as assessed by electronic diary (eDiary) and/or PI assessment, and compared to placebo
Number of participants with AEs or SAEs as assessed by physical examination Through study completion, an average of 9 months Number of participants with AEs or SAEs as assessed by physical examination, vital signs, local skin responses, as assessed by treatment arm (vaccine and placebo)
Incidence of AEs and serious adverse events (SAEs) Through study completion, an average of 9 months Incidence of AEs and SAEs
Change from the baseline in ECG Weeks 0 and 36 Clinically significant change from the baseline in electrocardiogram (ECG) as compared to placebo
Change from the baseline in physical examination Through study completion, an average of 9 months Clinically significant change from the baseline in physical examination, as compared to placebo
- Secondary Outcome Measures
Name Time Method Change in non-inflammatory lesion counts Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36 Absolute and percentage change from Baseline in the number of non-inflammatory acne lesions
Investigator's global assessment (IGA) - percentage of subjects with improvement Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36 Percentage of subjects with at least one-grade improvement in their Baseline IGA score (assessment of mild, clear or almost clear) \[scores: 0-4; 0=clear, 4=severe\]
Immunogenicity assessment Weeks 0, 4, 8, 12, 16, 24 and 36 The amount of vaccine-antigen-specific serum antibody titers (IgG), measured by ELISA, compared to placebo and compared among different treatment groups
Change in inflammatory lesion counts Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36 Absolute and percentage change from Baseline in the number of inflammatory acne lesions
Investigator's global assessment (IGA) - change from Baseline Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36 Absolute change in IGA score from Baseline \[scores: 0-4; 0=clear, 4=severe\]
Assessment of subjects' treatment acceptability Week 16 Treatment acceptability, as assessed by the pre-defined questionnaire
Trial Locations
- Locations (6)
Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB)
🇩🇪Bochum, North Rhine-Westphalia, Germany
UKSH, Campus Lübeck
🇩🇪Lübeck, Schleswig-Holstein, Germany
Universitätsklinikum Frankfurt
🇩🇪Frankfurt, Hesse, Germany
Universitäts-Hautklinik Tübingen
🇩🇪Tübingen, Baden-Wuerttemberg, Germany
Fachklinik Bad Bentheim
🇩🇪Bad Bentheim, North Rhine-Westphalia, Germany
CentroDerm
🇩🇪Wuppertal, North Rhine-Westphalia, Germany