Safety and Effectiveness of CNDO 201Trichuris Suis Ova (TSO) for the Treatment of Moderate to Severe Plaque Psoriasis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: TSO 2500
* Drug: TSO 7500


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; PASI ≥ 12 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TSO 2500<br>TSO 2500: 2500 embryonated, viable TSO/15 mL/day every 2 weeks X 10 weeks | Drug: TSO 2500<br>* TSO 2500: 2500 embryonated, viable TSO/15 mL/day every 2 weeks X 10 weeks<br>|
| Active Comparator: TSO 7500<br>TSO 7500: 7500 embryonated, viable TSO/15 mL/day every 2 weeks X 10 weeks | Drug: TSO 7500<br>* 12 weeks of treatment with TSO 2500 ova or TSO 7500 ova given every 2 weeks (a total of 6 doses).<br>* Other names: CNDO 201 Trichuris suis ova;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area and Severity Index (PASI) | 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. | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psoriasis severity | Percentage of patients who experience an improvement in disease severity as defined by a 50%, 75%, and 90% reduction of psoriasis severity (PASI 50, PASI 75, and PASI 90 response, respectively). | week 4 | 
| psoriasis severity | Percentage of patients who experience an improvement in disease severity as defined by a 50%, 75%, and 90% reduction of psoriasis severity (PASI 50, PASI 75, and PASI 90 response, respectively). | week 8 | 
| psoriasis severity | Percentage of patients who experience an improvement in disease severity as defined by a 50%, 75%, and 90% reduction of psoriasis severity (PASI 50, PASI 75, and PASI 90 response, respectively). | week 12 | 
| Physicians Global Assessment (PGA) | Percentage of patients with plaque type psoriasis who experience an improvement in disease severity as defined by a PGA ≤ 1. | week 4 | 
| Physicians Global Assessment (PGA) | Percentage of patients with plaque type psoriasis who experience an improvement in disease severity as defined by a PGA ≤ 1. | week 8 | 
| Physicians Global Assessment (PGA) | Percentage of patients with plaque type psoriasis who experience an improvement in disease severity as defined by a PGA ≤ 1. | week 12 | 
| Change in Body surface area (BSA) | Body surface area (BSA) mean and percent change from pre-treatment | baseline and week 12 | 
| Change in Dermatology Life Quality Index (DLQI) | DLQI mean (and percent) change from pre-treatment to Week 12 | baseline and at week 12 | 
| safety of TSO | The safety and tolerability of TSO will be evaluated via the frequency and severity of adverse events, changes in physical examinations, stool cultures, clinical laboratories, and vital signs. | up to week 38 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis, oral therapy, ova, Trichuris suis ova, TSO, CNDO 201 Trichuris suis ova