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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Icahn School of Medicine at Mount Sinai
New York, New York, United States
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.
Time frame: up to 12 weeks
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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: week 8
Physicians Global Assessment (PGA)
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Percentage of patients with plaque type psoriasis who experience an improvement in disease severity as defined by a PGA ≤ 1.
Time frame: week 12
Change in Body surface area (BSA)
Body surface area (BSA) mean and percent change from pre-treatment
Time frame: baseline and week 12
Change in Dermatology Life Quality Index (DLQI)
DLQI mean (and percent) change from pre-treatment to Week 12
Time frame: 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.
Time frame: up to week 38