Efficacy Study of Trichuris Suis Ova to Treat Chronic Plaque Psoriasis

Phase 1

Terminated

• Conditions: Psoriasis
• Interventions: Drug: Trichuris Suis Ova

• Registration Number: NCT01948271
• Lead Sponsor: Tufts Medical Center

Brief Summary

The purpose of this research study is to better understand whether trichuris suis ova (TSO) ingested orally may be safe and effective in the treatment of psoriasis.

Detailed Description

This is an open-label study to assess the safety and efficacy of 16 weeks of treatment with 7500 trichuris suis ova (TSO 7500) given every 2 weeks (a total of 8 doses) for the treatment of moderate-to-severe, chronic, plaque-type psoriasis.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-09-18
• Study First Submitted QC: 2013-09-18
• Study First Posted: 2013-09-23
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-14
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

1. Subjects with known history of intestinal parasitic infection, even if adequately treated, in the past 5 years
2. Subject received antibiotic, antifungal or antiparasitic medication in the last 2 weeks prior to Screening and/or would potentially require this during the study treatment period
3. Subject with history of drug or alcohol abuse within 6 months prior to screening
4. Subject with evidence of poor compliance with medical advice and instruction including diet or medication
5. Subject is unable or unwilling to swallow study medication suspension
6. Subject with a significant medical condition which puts the subject at risk for study participation and/or for any reason is considered by the Investigator to be an unsuitable candidate to receive TSO or is potentially put at risk by study procedures
7. Subjects who has participated in another clinical trial within 30 days of screening for this trial and/or any experimental treatment for this population
8. White blood cell count ≤3,000/mm3 (≤3.0 x 109/L) or ≥14,000/mm3 (≥14 x 109/L)
9. Platelet count ≤ 100,000/μL (≤100 x 109/L)
10. Serum creatinine >2 x upper limit of normal (ULN)
11. Aspartate or alanine aminotransferase >2 x ULN
12. Total bilirubin >2 mg/dL (34 μmol/L)
13. Hemoglobin < 9 g/dL
14. Subjects 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, cyclosporine, tacrolimus, mycophenolate mofetil, mycophenolic acid, etanercept, adalimumab, infliximab, ustekinumab, cimzia, or any other biologic agent targeted to any cell or cytokine in the immune system.
15. Subjects who are refractory to 2 or more biological agent plaque psoriasis therapies due to lack of efficacy
16. Subjects currently taking or who have taken in the past 2 weeks, topical steroids
17. Subjects on a non-stable dose of vitamin D analog in the past 30 days
18. Subjects currently taking or who have taken in the past 30 days any medications likely to improve psoriasis and thus interfere with evaluation. This may include, in addition to the medications listed above, phototherapy, methotrexate, hydroxyurea, or acitretin
19. Subjects with a diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease) or of irritable bowel syndrome
20. Subjects with HIV-1/HIV-2 antibody, hepatitis B surface antigen, hepatitis C antibody
21. Subject received non-steroidal anti-inflammatory drugs within 2 weeks before Baseline visit for more than 3 consecutive days, except acetylsalicylic acid ≤350 mg/d which is allowed
22. Women who are intending to become pregnant or who are breastfeeding or planning to breastfeed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TSO 7500	Trichuris Suis Ova	Subjects in this arm will receive doses of 7500 trichuris suis ova every two weeks, starting at the baseline visit, for a total of 8 doses.

Primary Outcome Measures

Name	Time	Method
Physician's area and severity index (PASI)	Screening, baseline, weeks 2, 4, 6, 8, 10, 12, 14, and 16	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI produces a numeric score that can range from 0 to 72 based on the body surface area of involvement and the severity of disease (induration, erythema and scale). A PASI-50 response is defined as ≥50% improvement in PASI score from baseline; PASI-75 and PASI-90 are similarly defined.

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability	Screening, baseline, weeks 2, 4, 6, 8, 10, 12, 14, 16, 20, and 38	Evaluated via the frequency and severity of adverse events, changes in physical examinations, stool studies (ova and parasites, culture, clostridium difficile toxin, and blood), clinical laboratories (liver function tests, creatine phosphokinase, complete metabolic profile, complete blood count), and vital signs (blood pressure, pulse and temperature).

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States