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

Acne Vulgaris Clinical Trial

— OREA  

Official title:

A Phase I, Multi-center, Double-blind, Randomized, Dose Escalating, Parallel Group, Placebo-controlled Safety, Tolerability and Immunogenicity Study of ORI-A-ce001 for the Treatment of Facial Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05131373
• Other study ID #: ORI-101-PAC
• Secondary ID: VBE00004U1111-12
• Status: Completed
• Phase: Phase 1
• Start date: September 28, 2021
• Est. completion date: November 27, 2023

Study information

• Verified date: January 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 27, 2023
• Est. primary completion date: November 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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: 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

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Drug:
• ORG101 - Experimental 1
C. acnes vaccine Injection, 25 mcg, 75 mcg, 225 mcg, 4 single i.m. injections given in monthly intervals
• ORG101PL - Placebo 1
Injection, sterile aqueous solution of aluminium hydroxide, 4 single i.m. injections given in monthly intervals

Locations

Country	Name	City	State
Germany	Fachklinik Bad Bentheim	Bad Bentheim	North Rhine-Westphalia
Germany	Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB)	Bochum	North Rhine-Westphalia
Germany	Universitätsklinikum Frankfurt	Frankfurt	Hesse
Germany	UKSH, Campus Lübeck	Lübeck	Schleswig-Holstein
Germany	Universitäts-Hautklinik Tübingen	Tübingen	Baden-Wuerttemberg
Germany	CentroDerm	Wuppertal	North Rhine-Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of solicited and unsolicited local and/or systemic adverse events (AEs)	Number of participants with AEs as assessed by electronic diary (eDiary) and/or PI assessment, and compared to placebo	7 days following each vaccination
Primary	Incidence of AEs and serious adverse events (SAEs)	Incidence of AEs and SAEs	Through study completion, an average of 9 months
Primary	Number of participants with AEs or SAEs as assessed by physical examination	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)	Through study completion, an average of 9 months
Primary	Change from the baseline in laboratory data	Clinically significant change from the baseline in laboratory data as compared to placebo	Through study completion, an average of 9 months
Primary	Change from the baseline in vital signs	Clinically significant change from the baseline in vital signs as compared to placebo	Through study completion, an average of 9 months
Primary	Change from the baseline in ECG	Clinically significant change from the baseline in electrocardiogram (ECG) as compared to placebo	Weeks 0 and 36
Primary	Change from the baseline in physical examination	Clinically significant change from the baseline in physical examination, as compared to placebo	Through study completion, an average of 9 months
Secondary	Immunogenicity assessment	The amount of vaccine-antigen-specific serum antibody titers (IgG), measured by ELISA, compared to placebo and compared among different treatment groups	Weeks 0, 4, 8, 12, 16, 24 and 36
Secondary	Change in inflammatory lesion counts	Absolute and percentage change from Baseline in the number of inflammatory acne lesions	Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36
Secondary	Change in non-inflammatory lesion counts	Absolute and percentage change from Baseline in the number of non-inflammatory acne lesions	Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36
Secondary	Investigator's global assessment (IGA) - change from Baseline	Absolute change in IGA score from Baseline [scores: 0-4; 0=clear, 4=severe]	Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36
Secondary	Investigator's global assessment (IGA) - percentage of subjects with improvement	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]	Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36
Secondary	Assessment of subjects' treatment acceptability	Treatment acceptability, as assessed by the pre-defined questionnaire	Week 16