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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02011269

Enrollment

Registered

2013-12-13

Start date

2014-03-31

Completion date

Unknown

Last updated

2015-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis

Keywords

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

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.

Interventions

BIOLOGICALTrichuris Suis Ova

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Mean percent change in Psoriasis Area and Severity Index (PASI) score	12 weeks	Mean percent change in Psoriasis Area and Severity Index (PASI) score from pre-treatment at Week 0 to Week 12

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026