NCT01474798已完成2 期
A Phase II Open Label Study of the Safety, Pharmacokinetics, and Efficacy of a True Human Anti-Inflammatory Therapeutic Antibody (RA-18C3) in Subjects With Moderate to Severe Acne Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 3
- 主要终点
- Safety and tolerability
研究概览
简要总结
This is a 91-day phase II, open label trial of the true human monoclonal antibody RA-18C3 in subjects with moderate to severe acne vulgaris. Ten (10) subjects will receive RA-18C3 via subcutaneous injection. Subjects will receive injections at Days 0, 21, and 42 for a total of 3 injections. Study drug will be administered under close observation in a facility equipped to handle medical emergencies. Subjects will not be discharged from the facility until at least 1 hour following the injection or 1 hour after their vital signs have stabilized. Safety will be assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and the recording of adverse clinical events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to moderately severe inflammatory acne vulgaris:
- •Investigator's Global Assessment grade of ≥ 3 and,
- •≥ 15 inflammatory lesions (no more than 6 nodules) and,
- •≥ 15 non-inflammatory lesions
- •Four week washout period for topical and oral antibiotic treatment
- •Four week washout period for topical retinoids
- •Negative pregnancy test at screening and at specified time points throughout the trial. For subjects with reproductive potential, a willingness to utilize contraception during the study and including 3 months after study completion. Sexually active men must use an accepted method of contraception during the study and including 3 months after study completion.
- •Subjects weighing ≥ 27 kg
- •Signed and dated Institutional Review Board (IRB) approved informed consent before any protocol-specific screening procedures are performed
排除标准
- •A diagnosis of Acne conglobata, acne fulminans, secondary acne, severe nodulocystic acne requiring treatment with isotretinoin, or other dermatologic conditions requiring interfering phototherapy, topical, or systemic treatment.
- •Treatment with any biologicals or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
- •Men with facial hair that would interfere with assessments
- •History of uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 3 months), ongoing congestive heart failure, and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
- •Hemoglobin <10.0 g/dL, or WBC <3.0 x 103/mm3, or platelet count <125 x 103/mm3, or creatinine > 1.5mg/dL, or AST/ALT >2 x ULN, or alkaline phosphatase >2 x ULN
- •Known HIV antibody, hepatitis B surface antigen and/or hepatitis C antibody.
- •History of malignancy within 5 years prior to study entry other than carcinoma in situ of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin.
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
- •History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA)
- •Infectious disease:
- •CRP >30 mg/L, fever, or infection requiring treatment with antibiotics within 3 weeks prior to Screening
- •Immunodeficiency
- •Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding
- •Receipt of a live (attenuated) vaccine within 1 month prior to Screening
- •Major surgery within 28 days prior to Day 0
- •Participation in an investigational drug or device trial within 30 days prior to Screening
研究组 & 干预措施
RA-18C3
Experimental
干预措施: RA-18C3 (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: 100 days
Incidence and type of adverse clinical events
次要结局
- Facial acne lesion count(56 days)
- Investigator's Global Assessment (IGA) score(56 days)
- Reduction in total acne lesion count, inflammatory and non-inflammatory lesion counts(56 days)
- RA-18C3 pharmacokinetics(70 days)
研究者
研究点 (3)
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