TSO for Plaque Psoriasis

Phase 2

Withdrawn

• Conditions: Plaque Psoriasis
• Interventions: Biological: Trichuris Suis Ova

• Registration Number: NCT02011269
• Lead Sponsor: Coronado Biosciences, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-12
• Study First Posted: 2013-12-13
• Study Start: 2014-03
• Primary Completion: 2015-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-05
• Last Update Posted: 2015-05-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
15000 TSO	Trichuris Suis Ova	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
Non-active treatment	Trichuris Suis Ova	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.
7500 TSO	Trichuris Suis Ova	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

Primary Outcome Measures

Name	Time	Method
Mean percent change in Psoriasis Area and Severity Index (PASI) score	12 weeks	Mean percent change in Psoriasis Area and Severity Index (PASI) score from pre-treatment at Week 0 to Week 12