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
Overview
- Phase
- Phase 1
- Intervention
- Trichuris Suis Ova
- Conditions
- Psoriasis
- Sponsor
- Tufts Medical Center
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Physician's area and severity index (PASI)
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Subjects with known history of intestinal parasitic infection, even if adequately treated, in the past 5 years
- •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
- •Subject with history of drug or alcohol abuse within 6 months prior to screening
- •Subject with evidence of poor compliance with medical advice and instruction including diet or medication
- •Subject is unable or unwilling to swallow study medication suspension
- •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
- •Subjects who has participated in another clinical trial within 30 days of screening for this trial and/or any experimental treatment for this population
- •White blood cell count ≤3,000/mm3 (≤3.0 x 109/L) or ≥14,000/mm3 (≥14 x 109/L)
- •Platelet count ≤ 100,000/μL (≤100 x 109/L)
- •Serum creatinine \>2 x upper limit of normal (ULN)
Arms & Interventions
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: Trichuris Suis Ova
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Safety and tolerability(Screening, baseline, weeks 2, 4, 6, 8, 10, 12, 14, 16, 20, and 38)