NCT01836939

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Mark Lebwohl · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	TSO 2500	TSO 2500: 2500 embryonated, viable TSO/15 mL/day every 2 weeks X 10 weeks
DRUG	TSO 7500	12 weeks of treatment with TSO 2500 ova or TSO 7500 ova given every 2 weeks (a total of 6 doses).

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-04-22
• Last updated: 2015-01-14

Locations

1 site across 1 country: United States