TSO for Plaque Psoriasis

NCT ID: NCT02011269

Last Updated: 2015-05-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31

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.

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Trichuris Suis Ova

Intervention Type: BIOLOGICAL

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

Group Type: ACTIVE_COMPARATOR

Trichuris Suis Ova

Intervention Type: BIOLOGICAL

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.

Group Type: PLACEBO_COMPARATOR

Trichuris Suis Ova

Intervention Type: BIOLOGICAL

Interventions

Trichuris Suis Ova

Intervention Type: BIOLOGICAL

Other Intervention Names

TSO

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:

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coronado Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Ryan

Role: STUDY_DIRECTOR

Coronado Biosciences

Other Identifiers

CNDO 201-201

Identifier Type: OTHER

Identifier Source: secondary_id

CNDO 201-201

Identifier Type: -

Identifier Source: org_study_id