CompletedPhase 1

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

Germany38 participantsStarted 2021-09-28

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

What they're measuring

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

Timeframe: 7 days following each vaccination

Incidence of AEs and serious adverse events (SAEs)

Timeframe: Through study completion, an average of 9 months

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

Timeframe: Through study completion, an average of 9 months

Change from the baseline in laboratory data

Timeframe: Through study completion, an average of 9 months

Change from the baseline in vital signs

Timeframe: Through study completion, an average of 9 months

Change from the baseline in ECG

Timeframe: Weeks 0 and 36

Change from the baseline in physical examination

Timeframe: Through study completion, an average of 9 months

Trial details

NCT IDNCT05131373

SponsorSanofi Pasteur, a Sanofi Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-27

View on ClinicalTrials.gov More Acne Vulgaris trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 7 days following each vaccination

Incidence of AEs and serious adverse events (SAEs)

Timeframe: Through study completion, an average of 9 months

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

Timeframe: Through study completion, an average of 9 months

Change from the baseline in laboratory data

Timeframe: Through study completion, an average of 9 months

Change from the baseline in vital signs

Timeframe: Through study completion, an average of 9 months

Change from the baseline in ECG

Timeframe: Weeks 0 and 36

Change from the baseline in physical examination

Timeframe: Through study completion, an average of 9 months