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TSO for Plaque Psoriasis

Primary Purpose

Plaque Psoriasis

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Trichuris Suis Ova
Sponsored by
Coronado Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring TSO, Ova, Psoriasis, plaque psoriasis, plaque-type, Coronado, Moderate to severe plaque psoriasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    7500 TSO

    15000 TSO

    Non-active treatment

    Arm Description

    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

    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

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    December 10, 2013
    Last Updated
    May 5, 2015
    Sponsor
    Coronado Biosciences, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02011269
    Brief Title
    TSO for Plaque Psoriasis
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study not conducted
    Study Start Date
    March 2014 (undefined)
    Primary Completion Date
    January 2015 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Coronado Biosciences, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Plaque Psoriasis
    Keywords
    TSO, Ova, Psoriasis, plaque psoriasis, plaque-type, Coronado, Moderate to severe plaque psoriasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    7500 TSO
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    15000 TSO
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Non-active treatment
    Arm Type
    Placebo Comparator
    Arm Description
    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 Type
    Biological
    Intervention Name(s)
    Trichuris Suis Ova
    Other Intervention Name(s)
    TSO
    Primary Outcome Measure Information:
    Title
    Mean percent change in Psoriasis Area and Severity Index (PASI) score
    Description
    Mean percent change in Psoriasis Area and Severity Index (PASI) score from pre-treatment at Week 0 to Week 12
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: Psoriasis covering a body surface area (BSA) ≥ 10%, and; PGA ≥ 3, and; 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Ryan
    Organizational Affiliation
    Coronado Biosciences
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    TSO for Plaque Psoriasis

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