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TSO for Plaque Psoriasis

This study has been withdrawn prior to enrollment.
(Study not conducted)
Sponsor:
Information provided by (Responsible Party):
Coronado Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT02011269
First received: December 10, 2013
Last updated: May 5, 2015
Last verified: May 2015
December 10, 2013
May 5, 2015
March 2014
January 2015   (Final data collection date for primary outcome measure)
Mean percent change in Psoriasis Area and Severity Index (PASI) score [ Time Frame: 12 weeks ]
Mean percent change in Psoriasis Area and Severity Index (PASI) score from pre-treatment at Week 0 to Week 12
Mean percent change in PASI score [ Time Frame: 12 weeks ]
Mean percent change in PASI score from pre-treatment at Week 0 to Week 12
Complete list of historical versions of study NCT02011269 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
TSO for Plaque Psoriasis
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Plaque Psoriasis
Biological: Trichuris Suis Ova
Other Name: TSO
  • 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
    Intervention: Biological: Trichuris Suis Ova
  • 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
    Intervention: Biological: Trichuris Suis Ova
  • 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.
    Intervention: Biological: Trichuris Suis Ova
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
January 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT02011269
CNDO 201-201
CNDO 201-201 ( Other Identifier: Coronado Biosciences )
No
Not Provided
Not Provided
Not Provided
Coronado Biosciences, Inc.
Coronado Biosciences, Inc.
Not Provided
Study Director: Michael Ryan Coronado Biosciences
Coronado Biosciences, Inc.
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP