Safety and Effectiveness of CNDO 201Trichuris Suis Ova (TSO) for the Treatment of Moderate to Severe Plaque Psoriasis

NCT01836939 | Completed Phase 1

• 1 other identifier: GCO 12-1881
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of CNDO 201Trichuris suis ova (TSO) for the treatment of moderate to severe plaque psoriasis.

Conditions

Psoriasis

Keywords

psoriasis, oral therapy; ova; Trichuris suis ova; TSO; CNDO 201 Trichuris suis ova

Outcome Measures

Primary Outcomes (1)

• Psoriasis Area and Severity Index (PASI)

  The PASI score will be calculated within each patient at each protocol-specified time point. Changes and percent changes from pretreatment to each on-treatment time point will then be derived. Mean percent change from pre-treatment to Week 12.

  up to 12 weeks

Secondary Outcomes (9)

• psoriasis severity

  week 4

• psoriasis severity

  week 8

• psoriasis severity

  week 12

• Physicians Global Assessment (PGA)

  week 4

• Physicians Global Assessment (PGA)

  week 8

Study Arms (2)

TSO 2500

ACTIVE COMPARATOR

TSO 2500: 2500 embryonated, viable TSO/15 mL/day every 2 weeks X 10 weeks

Drug: TSO 2500

TSO 7500

ACTIVE COMPARATOR

TSO 7500: 7500 embryonated, viable TSO/15 mL/day every 2 weeks X 10 weeks

Drug: TSO 7500

Interventions

TSO 2500 DRUG

TSO 2500: 2500 embryonated, viable TSO/15 mL/day every 2 weeks X 10 weeks

TSO 2500

TSO 7500 DRUG

12 weeks of treatment with TSO 2500 ova or TSO 7500 ova given every 2 weeks (a total of 6 doses).

Also known as: CNDO 201 Trichuris suis ova (TSO), Trichuris suis ova, TSO, CNDO 201 Trichuris suis ova

TSO 7500

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females, 18 to 75 years old.
• Diagnosis of stable plaque type psoriasis for at least 6 months prior to baseline
• Baseline moderate to severe psoriasis, defined as both of the following:
• Psoriasis covering a body surface area (BSA) ≥ 10%, and;
• PGA ≥ 3, and;
• PASI ≥ 12
• Must be in good health (except for psoriasis and psoriatic arthritis) as judged by the Investigator, based on medical history, physical examination, and clinical laboratories
• In the opinion of the investigator, must be a candidate for systemic therapy or phototherapy of psoriasis
• If a woman, before entry she must be:
• Postmenopausal, defined as 45 years of age with amenorrhea for at least 18 months, or \> 45 years of age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level \> 40 IU/mL, or Surgically postmenopausal (bilateral oophorectomy), or
• Surgically sterile (have had a hysterectomy or tubal ligation or otherwise be incapable of pregnancy), or
• 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, consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials, 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:

• Patients with known history of intestinal parasitic infection, even if adequately treated, in the past 5 years.
• Patient 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.
• Patient with history of drug or alcohol abuse within 6 months prior to Screening.
• Patient with evidence of poor compliance with medical advice and instruction including diet or medication.
• Patient is unable or unwilling to swallow study medication suspension.
• Patient with a significant medical condition which puts the patient 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.
• Patients 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)
• AST (SGOT) or ALT (SGPT) \> 2 x ULN
• Total bilirubin \>2 mg/dL (34 μmol/L)
• Hemoglobin \< 9 g/dL
• Patients 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, FK506, mycophenolate mofetil, mycophenolic acid, etanercept, adalimumab, infliximab, ustekinumab, cimzia, or any other biologic agent targeted to any cell or cytokine in the immune system.
• Patients who are refractory to 2 or more biological agent plaque psoriasis therapies due to lack of efficacy.

Sponsors & Collaborators

• Mark Lebwohl: lead
• Coronado Biosciences, Inc.: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, 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

• Mark Lebwohl, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor & Chair, Dermatology

Study Record Dates

• First Submitted: March 26, 2013
• First Posted: April 22, 2013
• Study Start: March 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

US (1)