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Efficacy Study of Trichuris Suis Ova to Treat Chronic Plaque Psoriasis

This study has been terminated.
(lack of efficacy)
ClinicalTrials.gov Identifier:
First Posted: September 23, 2013
Last Update Posted: September 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tufts Medical Center
September 18, 2013
September 23, 2013
September 15, 2016
July 2013
September 2014   (Final data collection date for primary outcome measure)
Physician's area and severity index (PASI) [ Time Frame: 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.
Same as current
Complete list of historical versions of study NCT01948271 on ClinicalTrials.gov Archive Site
Safety and tolerability [ Time Frame: 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).
Same as current
Not Provided
Not Provided
Efficacy Study of Trichuris Suis Ova to Treat Chronic Plaque Psoriasis
An Open-label Pilot Study to Assess the Safety and Efficacy of Trichuris Suis Ova for the Treatment of Moderate to Severe Chronic Plaque Psoriasis
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.
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.
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: Trichuris Suis Ova
During the treatment phase, study drug will be provided in a liquid form and will be administered every 2 weeks, starting with the Baseline visit, through Week 14.
Other Name: TSO 7500
Experimental: TSO 7500
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.
Intervention: Drug: Trichuris Suis Ova

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
September 2014
September 2014   (Final data collection date for primary outcome measure)

Inclusion criteria:

  1. Males or females, 18-75 years old
  2. Diagnosis of stable plaque type psoriasis for at least 6 months prior to baseline
  3. Baseline moderate to severe psoriasis, defined as:

    1. Psoriasis covering a body surface area (BSA) ≥10%;
    2. Physician's global assessment (PGA) ≥3, and;
    3. PASI ≥12
  4. Must be in good health as judged by the PI, based on medical history, physical examination, and clinical laboratories
  5. In the opinion of the PI, must be a candidate for systemic therapy or phototherapy of psoriasis
  6. If a woman, before entry she must be one of the following:

    1. Postmenopausal, defined as 45 years of age with amenorrhea for at least 18 months, or >45 years of age with amenorrhea for >6 months and a serum follicle stimulating hormone (FSH) level >40 IU/mL, or surgically postmenopausal (bilateral oophorectomy)
    2. surgically sterile (have had a hysterectomy or tubal ligation or otherwise be incapable of pregnancy)
    3. If heterosexually active, practicing a highly effective method of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method (eg, condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel), or male partner sterilization for the duration of their participation in the study and for 2 months after receiving the last administration of any study agent; or
    4. Not heterosexually active
  7. Women of childbearing potential must have a negative pregnancy test (urine and serum) prior to randomization
  8. Agree to avoid prolonged exposure to natural sunlight or tanning beds or phototherapy devices for the duration of the study
  9. Agree to avoid any prohibited concomitant medications as detailed below for the duration of the study and for 4 weeks prior to baseline
  10. Negative stool culture
  11. Subject has the ability to provide informed consent
  12. Subjects who are on inhaled or ophthalmic steroids are allowed

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Plan to Share IPD: No
Tufts Medical Center
Tufts Medical Center
Not Provided
Principal Investigator: Alice B Gottlieb, MD, PhD Tufts Medical Center, Department of Dermatology
Tufts Medical Center
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP