TSO for Plaque Psoriasis

Study Overview
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Brief Summary
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This is a randomized, blinded, multicenter study to assess the safety and treatment effect of 12 weeks of Trichuris suis ova in subjects diagnosed with moderate to severe chronic plaque psoriasis.

Official Title
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A Randomized, Blinded, Placebo-controlled Multicenter Study to Assess the Safety and Efficacy of Trichuris Suis Ova for the Treatment of Moderate to Severe Chronic Plaque Psoriasis

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Biological: Trichuris Suis Ova


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 Exclusion Criteria: 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, methotrexate, 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 on inhaled or ophthalmic steroids are allowed. Patients who have demonstrated a primary lack of response to any one of the following biologic agents: etanercept, adalimumab, infliximab or ustekinumab. Patients who initially responded to one of these agents but subsequently lost response (secondary lack of response) are eligible for study entry; however, secondary lack of response to more than one of these agents will exclude the patient from study entry.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 7500 TSO<br>7500 active Trichuris suis ova will be provided in a15 mL of aqueous suspension (supplied in 30 mL glass containers) administered orally, once every 2 weeks for 10 weeks | Biological: Trichuris Suis Ova<br> <br> * Other names: TSO;|
| Active Comparator: 15000 TSO<br>15000 active Trichuris suis ova will be provided in two 15 mL of aqueous suspension (supplied in 30 mL glass containers) administered orally, once every 2 weeks for 10 weeks | Biological: Trichuris Suis Ova<br> <br> * Other names: TSO;|
| Placebo Comparator: Non-active treatment<br>The TSO placebo drug product is a non-sterile, 15 mL aqueous solution containing phosphate buffer, pH 5 and 0.05% potassium sorbate as antimicrobial preservative. The TSO placebo is supplied in two 30 mL glass containers that is identical to the container/closure described above for the active drug product. | Biological: Trichuris Suis Ova<br> <br> * Other names: TSO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean percent change in Psoriasis Area and Severity Index (PASI) score | Mean percent change in Psoriasis Area and Severity Index (PASI) score from pre-treatment at Week 0 to Week 12 | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TSO, Ova, Psoriasis, plaque psoriasis, plaque-type, Coronado, Moderate to severe plaque psoriasis