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Completed

NCT Number: NCT05131373

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

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.

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Key information

Conditions

Acne Vulgaris Acne Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Universitäts-Hautklinik Tübingen, Tübingen, Baden-Wurttemberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ORG101 - Experimental 1

Drug

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

ORG101PL - Placebo 1

Drug

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

Primary outcomes

  1. Incidence of solicited and unsolicited local and/or systemic adverse events (AEs)

    Time frame: 7 days following each vaccination

    Number of participants with AEs as assessed by electronic diary (eDiary) and/or PI assessment, and compared to placebo

  2. Incidence of AEs and serious adverse events (SAEs)

    Time frame: Through study completion, an average of 9 months

    Incidence of AEs and SAEs

  3. Number of participants with AEs or SAEs as assessed by physical examination

    Time frame: 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)

  4. Change from the baseline in laboratory data

    Time frame: Through study completion, an average of 9 months

    Clinically significant change from the baseline in laboratory data as compared to placebo

  5. Change from the baseline in vital signs

    Time frame: Through study completion, an average of 9 months

    Clinically significant change from the baseline in vital signs as compared to placebo

  6. Change from the baseline in ECG

    Time frame: Weeks 0 and 36

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

  7. Change from the baseline in physical examination

    Time frame: Through study completion, an average of 9 months

    Clinically significant change from the baseline in physical examination, as compared to placebo

Secondary outcomes

  1. Immunogenicity assessment

    Time frame: 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

  2. Change in inflammatory lesion counts

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

    Absolute and percentage change from Baseline in the number of inflammatory acne lesions

  3. Change in non-inflammatory lesion counts

    Time frame: 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

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

    Time frame: 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]

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

    Time frame: 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]

  6. Assessment of subjects' treatment acceptability

    Time frame: Week 16

    Treatment acceptability, as assessed by the pre-defined questionnaire

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study 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

Acronym: OREA

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 23, 2021
Registry last updated
Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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