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

NCT05131373 | Completed Phase 1 DMC

• 3 other identifiers: ORI-101-PACVBE00004U1111-1294-8125
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 6

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

Keywords

acne vulgaris; C. acnes; vaccine; dose escalation; first in human; FIH; skin microbiome; placebo

Outcome Measures

Primary Outcomes (7)

• 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

• Incidence of AEs and serious adverse events (SAEs)

  Incidence of AEs and SAEs

  Through study completion, an average of 9 months

• 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

• 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

• 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

• Change from the baseline in ECG

  Clinically significant change from the baseline in electrocardiogram (ECG) as compared to placebo

  Weeks 0 and 36

• 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 Outcomes (6)

• Immunogenicity assessment

  Weeks 0, 4, 8, 12, 16, 24 and 36

• Change in inflammatory lesion counts

  Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36

• Change in non-inflammatory lesion counts

  Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36

• Investigator's global assessment (IGA) - change from Baseline

  Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36

• Investigator's global assessment (IGA) - percentage of subjects with improvement

  Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36

Study Arms (2)

Experimental 1

EXPERIMENTAL

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

Drug: ORG101 - Experimental 1

Placebo 1

PLACEBO COMPARATOR

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

Drug: ORG101PL - Placebo 1

Interventions

ORG101 - Experimental 1 DRUG

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

Experimental 1

ORG101PL - Placebo 1 DRUG

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

Placebo 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (6)

Universitäts-Hautklinik Tübingen

Tübingen, Baden-Wurttemberg, 72074, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Fachklinik Bad Bentheim

Bad Bentheim, North Rhine-Westphalia, 48455, Germany

Location

Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB)

Bochum, North Rhine-Westphalia, 44791, Germany

Location

CentroDerm

Wuppertal, North Rhine-Westphalia, 42287, Germany

Location

UKSH, Campus Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: November 23, 2021
• Study Start: September 28, 2021
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

DE (6)