NCT01836939已完成1 期
A Randomized Open-label Two-arm Pilot Study to Assess the Safety and Efficacy of Trichuris Suis Ova for the Treatment of Moderate to Severe Chronic Plaque Psoriasis. Protocol: Psoriasis IIT
Mark Lebwohl1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2013年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Psoriasis Area and Severity Index (PASI)
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of CNDO 201Trichuris suis ova (TSO) for the treatment of moderate to severe plaque psoriasis.
详细描述
The purpose of this study is to evaluate the safety and effectiveness of CNDO 201Trichuris suis ova (TSO) for the treatment of moderate to severe plaque psoriasis.
Psoriasis is driven by T-cell infiltration in the epidermis. The T-cells involved in psoriasis exhibit a Th17-like and a Th1-like cytokine secretion profile. This excess Th17/Th1 response is thought to play a critical role in the development of psoriasis, and reducing Th17/Th1 activity would be a potential way of halting the inflammatory process leading to psoriasis.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females, 18 to 75 years old.
- •Diagnosis of stable plaque type psoriasis for at least 6 months prior to baseline
- •Baseline moderate to severe psoriasis, defined as both of the following:
- •Psoriasis covering a body surface area (BSA) ≥ 10%, and;
- •PGA ≥ 3, and;
- •Must be in good health (except for psoriasis and psoriatic arthritis) as judged by the Investigator, based on medical history, physical examination, and clinical laboratories
- •In the opinion of the investigator, must be a candidate for systemic therapy or phototherapy of psoriasis
- •If a woman, before entry she must be:
- •Postmenopausal, defined as 45 years of age with amenorrhea for at least 18 months, or > 45 years of age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level > 40 IU/mL, or Surgically postmenopausal (bilateral oophorectomy), or
- •Surgically sterile (have had a hysterectomy or tubal ligation or otherwise be incapable of pregnancy), or
- •If heterosexually active, practicing a highly effective method of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method (eg, condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel), or male partner sterilization, consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials, for the duration of their participation in the study and for 2 months after receiving the last administration of any study agent, or
- •Not heterosexually active
- •Women of childbearing potential must have a negative pregnancy test (urine and serum) prior to randomization
- •Agree to avoid prolonged exposure to natural sunlight or tanning beds or phototherapy devices for the duration of the study
- •Agree to avoid any prohibited concomitant medications as detailed below for the duration of the study and for 4 weeks prior to baseline unless indication otherwise
- •Negative stool culture.
- •Patient has the ability to provide informed consent.
排除标准
- •Patients with known history of intestinal parasitic infection, even if adequately treated, in the past 5 years.
- •Patient received antibiotic, antifungal or antiparasitic medication in the last 2 weeks prior to Screening and/or would potentially require this during the study treatment period.
- •Patient with history of drug or alcohol abuse within 6 months prior to Screening.
- •Patient with evidence of poor compliance with medical advice and instruction including diet or medication.
- •Patient is unable or unwilling to swallow study medication suspension.
- •Patient with a significant medical condition which puts the patient at risk for study participation and/or for any reason is considered by the Investigator to be an unsuitable candidate to receive TSO or is potentially put at risk by study procedures.
- •Patients who has participated in another clinical trial within 30 days of Screening for this trial and/or any experimental treatment for this population.
- •White blood cell count ≤ 3,000/mm3 (≤ 3.0 x 109/L) or ≥ 14,000/mm3 (≥14 x 109/L)
- •Platelet count ≤ 100,000/μL (≤100 x 109/L)
- •Serum creatinine >2 x upper limit of normal (ULN)
- •AST (SGOT) or ALT (SGPT) > 2 x ULN
- •Total bilirubin >2 mg/dL (34 μmol/L)
- •Hemoglobin < 9 g/dL
- •Patients who are currently taking or have taken in the past 30 days, for any reason, any medication that, in the opinion of the investigator, suppressed the immune response. This may include but is not limited to systemic steroids, azathioprine, cyclosporine, FK506, mycophenolate mofetil, mycophenolic acid, etanercept, adalimumab, infliximab, ustekinumab, cimzia, or any other biologic agent targeted to any cell or cytokine in the immune system.
- •Patients who are refractory to 2 or more biological agent plaque psoriasis therapies due to lack of efficacy.
- •Patients currently taking or who have taken in the past 2 weeks, topical steroids.
- •Patients on a non-stable dose of vitamin D analog in the past 30 days.
- •Patients currently taking or who have taken in the past 30 days any medications likely to improve psoriasis and thus interfere with evaluation. This may include, in addition to the medications listed above, phototherapy, methotrexate, hydroxyurea, or acitretin.
- •Patients with a diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease) or of irritable bowel syndrome
- •Patients with HIV-1/HIV-2 antibody, hepatitis B surface antigen, hepatitis C antibody.
- •Patient received non-steroidal anti-inflammatory drugs (NSAIDS) within 2 weeks before Baseline visit for more than 3 consecutive days, except acetylsalicylic acid ≤ 350 mg/d which is allowed.
- •Women who are pregnant, intending to become pregnant, breastfeeding or planning to breastfeed during the study.
研究组 & 干预措施
TSO 2500
Active Comparator
TSO 2500: 2500 embryonated, viable TSO/15 mL/day every 2 weeks X 10 weeks
干预措施: TSO 2500 (Drug)
TSO 7500
Active Comparator
TSO 7500: 7500 embryonated, viable TSO/15 mL/day every 2 weeks X 10 weeks
干预措施: TSO 7500 (Drug)
结局指标
主要结局
Psoriasis Area and Severity Index (PASI)
时间窗: up to 12 weeks
The PASI score will be calculated within each patient at each protocol-specified time point. Changes and percent changes from pretreatment to each on-treatment time point will then be derived. Mean percent change from pre-treatment to Week 12.
次要结局
- Change in Body surface area (BSA)(baseline and week 12)
- Change in Dermatology Life Quality Index (DLQI)(baseline and at week 12)
- psoriasis severity(week 12)
- safety of TSO(up to week 38)
- Physicians Global Assessment (PGA)(week 12)
研究者
Mark Lebwohl
Professor & Chair, Dermatology
Icahn School of Medicine at Mount Sinai
研究点 (1)
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