Clinical trial NCT01948271: Efficacy Study of Trichuris Suis Ova to Treat Chronic Plaque Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Psoriasis
Keywords: Psoriasis
Trichuris suis ova
T-lymphocytes
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2013-09-23
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physician's area and severity index (PASI)
timeFrame: Screening, baseline, weeks 2, 4, 6, 8, 10, 12, 14, and 16
Secondary outcomes:
measure: Safety and tolerability
timeFrame: Screening, baseline, weeks 2, 4, 6, 8, 10, 12, 14, 16, 20, and 38
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center, Department of Dermatology
name: Alice B Gottlieb, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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