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

NCT ID: NCT05131373

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-28
• Study Completion Date: 2023-11-27

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.

Conditions

Acne Vulgaris; Acne

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental 1

C. acnes vaccine in adjuvanted formulation will be administered in double-blind fashion in 3 single increasing doses given i.m.

Group Type: EXPERIMENTAL

ORG101 - Experimental 1

Intervention Type: DRUG

C. acnes vaccine Injection, 25 mcg, 75 mcg, 225 mcg, 4 single i.m. injections given in monthly intervals

Placebo 1

Placebo in adjuvanted formulation will be administered in double-blind fashion in single i.m. injections

Group Type: PLACEBO_COMPARATOR

ORG101PL - Placebo 1

Intervention Type: DRUG

Injection, sterile aqueous solution of aluminium hydroxide, 4 single i.m. injections given in monthly intervals

Interventions

ORG101 - Experimental 1

C. acnes vaccine Injection, 25 mcg, 75 mcg, 225 mcg, 4 single i.m. injections given in monthly intervals

Intervention Type: DRUG

ORG101PL - Placebo 1

Injection, sterile aqueous solution of aluminium hydroxide, 4 single i.m. injections given in monthly intervals

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Universitäts-Hautklinik Tübingen

Tübingen, Baden-Wurttemberg, Germany

Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse, Germany

Fachklinik Bad Bentheim

Bad Bentheim, North Rhine-Westphalia, Germany

Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB)

Bochum, North Rhine-Westphalia, Germany

CentroDerm

Wuppertal, North Rhine-Westphalia, Germany

UKSH, Campus Lübeck

Lübeck, Schleswig-Holstein, Germany

Countries

Germany

Other Identifiers

VBE00004

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1294-8125

Identifier Type: REGISTRY

Identifier Source: secondary_id

ORI-101-PAC

Identifier Type: -

Identifier Source: org_study_id