An Open-label Pilot Study to Assess the Safety and Efficacy of Trichuris Suis Ova for the Treatment of Moderate to Severe Chronic Plaque Psoriasis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Physician's area and severity index (PASI)
研究概览
简要总结
The purpose of this research study is to better understand whether trichuris suis ova (TSO) ingested orally may be safe and effective in the treatment of psoriasis.
详细描述
This is an open-label study to assess the safety and efficacy of 16 weeks of treatment with 7500 trichuris suis ova (TSO 7500) given every 2 weeks (a total of 8 doses) for the treatment of moderate-to-severe, chronic, plaque-type psoriasis.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Subjects with known history of intestinal parasitic infection, even if adequately treated, in the past 5 years
- •Subject 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
- •Subject with history of drug or alcohol abuse within 6 months prior to screening
- •Subject with evidence of poor compliance with medical advice and instruction including diet or medication
- •Subject is unable or unwilling to swallow study medication suspension
- •Subject with a significant medical condition which puts the subject 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
- •Subjects 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)
- •Aspartate or alanine aminotransferase >2 x ULN
- •Total bilirubin >2 mg/dL (34 μmol/L)
- •Hemoglobin < 9 g/dL
- •Subjects 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, tacrolimus, mycophenolate mofetil, mycophenolic acid, etanercept, adalimumab, infliximab, ustekinumab, cimzia, or any other biologic agent targeted to any cell or cytokine in the immune system.
- •Subjects who are refractory to 2 or more biological agent plaque psoriasis therapies due to lack of efficacy
- •Subjects currently taking or who have taken in the past 2 weeks, topical steroids
- •Subjects on a non-stable dose of vitamin D analog in the past 30 days
- •Subjects 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
- •Subjects with a diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease) or of irritable bowel syndrome
- •Subjects with HIV-1/HIV-2 antibody, hepatitis B surface antigen, hepatitis C antibody
- •Subject received non-steroidal anti-inflammatory drugs within 2 weeks before Baseline visit for more than 3 consecutive days, except acetylsalicylic acid ≤350 mg/d which is allowed
- •Women who are intending to become pregnant or who are breastfeeding or planning to breastfeed
研究组 & 干预措施
TSO 7500
Subjects in this arm will receive doses of 7500 trichuris suis ova every two weeks, starting at the baseline visit, for a total of 8 doses.
干预措施: Trichuris Suis Ova (Drug)
结局指标
主要结局
Physician's area and severity index (PASI)
时间窗: Screening, baseline, weeks 2, 4, 6, 8, 10, 12, 14, and 16
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI produces a numeric score that can range from 0 to 72 based on the body surface area of involvement and the severity of disease (induration, erythema and scale). A PASI-50 response is defined as ≥50% improvement in PASI score from baseline; PASI-75 and PASI-90 are similarly defined.
次要结局
- Safety and tolerability(Screening, baseline, weeks 2, 4, 6, 8, 10, 12, 14, 16, 20, and 38)