Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

TSO for Plaque Psoriasis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Coronado Biosciences, Inc.
Information provided by (Responsible Party):
Coronado Biosciences, Inc. Identifier:
First received: December 10, 2013
Last updated: January 31, 2014
Last verified: January 2014

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.

Condition Intervention Phase
Plaque Psoriasis
Biological: Trichuris Suis Ova
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Coronado Biosciences, Inc.:

Primary Outcome Measures:
  • Mean percent change in Psoriasis Area and Severity Index (PASI) score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Mean percent change in Psoriasis Area and Severity Index (PASI) score from pre-treatment at Week 0 to Week 12

Estimated Enrollment: 25
Study Start Date: March 2014
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 7500 TSO
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
Biological: Trichuris Suis Ova
Other Name: TSO
Active Comparator: 15000 TSO
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
Biological: Trichuris Suis Ova
Other Name: TSO
Placebo Comparator: Non-active treatment
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.
Biological: Trichuris Suis Ova
Other Name: TSO


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02011269

Contact: Michael Ryan
Contact: Amy Wheeler

Sponsors and Collaborators
Coronado Biosciences, Inc.
Study Director: Michael Ryan Coronado Biosciences
  More Information

No publications provided

Responsible Party: Coronado Biosciences, Inc. Identifier: NCT02011269     History of Changes
Other Study ID Numbers: CNDO 201-201, CNDO 201-201
Study First Received: December 10, 2013
Last Updated: January 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Coronado Biosciences, Inc.:
plaque psoriasis
Moderate to severe plaque psoriasis

Additional relevant MeSH terms:
Skin Diseases
Skin Diseases, Papulosquamous processed this record on March 03, 2015