TSO for Plaque Psoriasis

NCT02011269 | Withdrawn Phase 2

• 1 other identifier: CNDO 201-201
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

TSO; Ova; Psoriasis; plaque psoriasis; plaque-type; Coronado; Moderate to severe plaque psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Study Arms (3)

7500 TSO

ACTIVE COMPARATOR

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

15000 TSO

ACTIVE COMPARATOR

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

Non-active treatment

PLACEBO COMPARATOR

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

Interventions

Trichuris Suis Ova BIOLOGICAL

Also known as: TSO

15000 TSO; 7500 TSO; Non-active treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coronado Biosciences, Inc.: lead

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Michael Ryan

  Coronado Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 13, 2013
• Study Start: March 1, 2014
• Primary Completion: January 1, 2015
• Last Updated: May 6, 2015

Record last verified: 2015-05