Efficacy Study of Trichuris Suis Ova to Treat Chronic Plaque Psoriasis

NCT01948271 | Terminated Phase 1

• 1 other identifier: TSOPSO13
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Psoriasis; Trichuris suis ova; T-lymphocytes

Outcome Measures

Primary Outcomes (1)

• Physician's area and severity index (PASI)

  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.

  Screening, baseline, weeks 2, 4, 6, 8, 10, 12, 14, and 16

Secondary Outcomes (1)

• Safety and tolerability

  Screening, baseline, weeks 2, 4, 6, 8, 10, 12, 14, 16, 20, and 38

Study Arms (1)

TSO 7500

EXPERIMENTAL

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.

Drug: Trichuris Suis Ova

Interventions

Trichuris Suis Ova DRUG

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.

Also known as: TSO 7500

TSO 7500

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females, 18-75 years old
• Diagnosis of stable plaque type psoriasis for at least 6 months prior to baseline
• Baseline moderate to severe psoriasis, defined as:
• Psoriasis covering a body surface area (BSA) ≥10%;
• Physician's global assessment (PGA) ≥3, and;
• PASI ≥12
• Must be in good health as judged by the PI, based on medical history, physical examination, and clinical laboratories
• In the opinion of the PI, must be a candidate for systemic therapy or phototherapy of psoriasis
• If a woman, before entry she must be one of the following:
• 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)
• surgically sterile (have had a hysterectomy or tubal ligation or otherwise be incapable of pregnancy)
• 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
• Not heterosexually active
• Women of childbearing potential must have a negative pregnancy test (urine and serum) prior to randomization
• Agree to avoid prolonged exposure to natural sunlight or tanning beds or phototherapy devices for the duration of the study

You may not qualify if:

• 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)
• Aspartate or alanine aminotransferase \>2 x ULN
• Total bilirubin \>2 mg/dL (34 μmol/L)
• Hemoglobin \< 9 g/dL
• 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.
• Subjects who are refractory to 2 or more biological agent plaque psoriasis therapies due to lack of efficacy

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (4)

• Barrett JC, Hansoul S, Nicolae DL, Cho JH, Duerr RH, Rioux JD, Brant SR, Silverberg MS, Taylor KD, Barmada MM, Bitton A, Dassopoulos T, Datta LW, Green T, Griffiths AM, Kistner EO, Murtha MT, Regueiro MD, Rotter JI, Schumm LP, Steinhart AH, Targan SR, Xavier RJ; NIDDK IBD Genetics Consortium; Libioulle C, Sandor C, Lathrop M, Belaiche J, Dewit O, Gut I, Heath S, Laukens D, Mni M, Rutgeerts P, Van Gossum A, Zelenika D, Franchimont D, Hugot JP, de Vos M, Vermeire S, Louis E; Belgian-French IBD Consortium; Wellcome Trust Case Control Consortium; Cardon LR, Anderson CA, Drummond H, Nimmo E, Ahmad T, Prescott NJ, Onnie CM, Fisher SA, Marchini J, Ghori J, Bumpstead S, Gwilliam R, Tremelling M, Deloukas P, Mansfield J, Jewell D, Satsangi J, Mathew CG, Parkes M, Georges M, Daly MJ. Genome-wide association defines more than 30 distinct susceptibility loci for Crohn's disease. Nat Genet. 2008 Aug;40(8):955-62. doi: 10.1038/ng.175. Epub 2008 Jun 29.

  PMID: 18587394 BACKGROUND

• Baumgart DC, Sandborn WJ. Inflammatory bowel disease: clinical aspects and established and evolving therapies. Lancet. 2007 May 12;369(9573):1641-57. doi: 10.1016/S0140-6736(07)60751-X.

  PMID: 17499606 BACKGROUND

• Crohn BB, Ginzburg L, Oppenheimer GD. Regional ileitis: a pathologic and clinical entity. 1932. Mt Sinai J Med. 2000 May;67(3):263-8. No abstract available.

  PMID: 10828911 BACKGROUND

• Loftus EV Jr, Schoenfeld P, Sandborn WJ. The epidemiology and natural history of Crohn's disease in population-based patient cohorts from North America: a systematic review. Aliment Pharmacol Ther. 2002 Jan;16(1):51-60. doi: 10.1046/j.1365-2036.2002.01140.x.

  PMID: 11856078 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Alice B Gottlieb, MD, PhD

  Tufts Medical Center, Department of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: September 23, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 15, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)