TSO for Plaque Psoriasis

Plaque Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02011269
• Other study ID #: CNDO 201-201
• Secondary ID: CNDO 201-201
• Status: Withdrawn
• Phase: Phase 2
• First received: December 10, 2013
• Last updated: May 5, 2015
• Start date: March 2014

Study information

• Verified date: May 2015
• Source: Coronado Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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:

1. Psoriasis covering a body surface area (BSA) = 10%, and;

2. PGA = 3, and;

3. 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Biological:
• Trichuris Suis Ova

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Coronado Biosciences, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No