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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 6
- 主要终点
- Change from the baseline in laboratory data
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental 1
C. acnes vaccine in adjuvanted formulation will be administered in double-blind fashion in 3 single increasing doses given i.m.
干预措施: ORG101 - Experimental 1 (Drug)
Placebo 1
Placebo in adjuvanted formulation will be administered in double-blind fashion in single i.m. injections
干预措施: ORG101PL - Placebo 1 (Drug)
结局指标
主要结局
Change from the baseline in laboratory data
时间窗: Through study completion, an average of 9 months
Clinically significant change from the baseline in laboratory data as compared to placebo
Change from the baseline in vital signs
时间窗: Through study completion, an average of 9 months
Clinically significant change from the baseline in vital signs as compared to placebo
Incidence of solicited and unsolicited local and/or systemic adverse events (AEs)
时间窗: 7 days following each vaccination
Number of participants with AEs as assessed by electronic diary (eDiary) and/or PI assessment, and compared to placebo
Number of participants with AEs or SAEs as assessed by physical examination
时间窗: 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)
Incidence of AEs and serious adverse events (SAEs)
时间窗: Through study completion, an average of 9 months
Incidence of AEs and SAEs
Change from the baseline in ECG
时间窗: Weeks 0 and 36
Clinically significant change from the baseline in electrocardiogram (ECG) as compared to placebo
Change from the baseline in physical examination
时间窗: Through study completion, an average of 9 months
Clinically significant change from the baseline in physical examination, as compared to placebo
次要结局
- Change in non-inflammatory lesion counts(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)
- 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)
- Investigator's global assessment (IGA) - change from Baseline(Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36)
- Assessment of subjects' treatment acceptability(Week 16)