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| ID | Type | Description | Link |
|---|---|---|---|
| CNDO 201-201 | Other Identifier | Coronado Biosciences |
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Study not conducted
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7500 TSO | Active Comparator | 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 |
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| 15000 TSO | Active Comparator | 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 |
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| Non-active treatment | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trichuris Suis Ova | Biological |
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| 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 |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Ryan | Coronado Biosciences | Study Director |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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