- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01836939
Safety and Effectiveness of CNDO 201Trichuris Suis Ova (TSO) for the Treatment of Moderate to Severe Plaque Psoriasis
A Randomized Open-label Two-arm Pilot Study to Assess the Safety and Efficacy of Trichuris Suis Ova for the Treatment of Moderate to Severe Chronic Plaque Psoriasis. Protocol: Psoriasis IIT
Study Overview
Detailed Description
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.
Psoriasis is driven by T-cell infiltration in the epidermis. The T-cells involved in psoriasis exhibit a Th17-like and a Th1-like cytokine secretion profile. This excess Th17/Th1 response is thought to play a critical role in the development of psoriasis, and reducing Th17/Th1 activity would be a potential way of halting the inflammatory process leading to psoriasis.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- Agree to avoid any prohibited concomitant medications as detailed below for the duration of the study and for 4 weeks prior to baseline unless indication otherwise
- Negative stool culture.
- Patient has the ability to provide informed consent.
Exclusion Criteria:
- 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.
- Patients currently taking or who have taken in the past 2 weeks, topical steroids.
- Patients on a non-stable dose of vitamin D analog in the past 30 days.
- Patients 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.
- Patients with a diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease) or of irritable bowel syndrome
- Patients with HIV-1/HIV-2 antibody, hepatitis B surface antigen, hepatitis C antibody.
- Patient received non-steroidal anti-inflammatory drugs (NSAIDS) within 2 weeks before Baseline visit for more than 3 consecutive days, except acetylsalicylic acid ≤ 350 mg/d which is allowed.
- Women who are pregnant, intending to become pregnant, breastfeeding or planning to breastfeed during the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: TSO 2500
TSO 2500: 2500 embryonated, viable TSO/15 mL/day every 2 weeks X 10 weeks
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TSO 2500: 2500 embryonated, viable TSO/15 mL/day every 2 weeks X 10 weeks
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Active Comparator: TSO 7500
TSO 7500: 7500 embryonated, viable TSO/15 mL/day every 2 weeks X 10 weeks
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12 weeks of treatment with TSO 2500 ova or TSO 7500 ova given every 2 weeks (a total of 6 doses).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psoriasis Area and Severity Index (PASI)
Time Frame: up to 12 weeks
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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.
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up to 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
psoriasis severity
Time Frame: week 4
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Percentage of patients who experience an improvement in disease severity as defined by a 50%, 75%, and 90% reduction of psoriasis severity (PASI 50, PASI 75, and PASI 90 response, respectively).
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week 4
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psoriasis severity
Time Frame: week 8
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Percentage of patients who experience an improvement in disease severity as defined by a 50%, 75%, and 90% reduction of psoriasis severity (PASI 50, PASI 75, and PASI 90 response, respectively).
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week 8
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psoriasis severity
Time Frame: week 12
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Percentage of patients who experience an improvement in disease severity as defined by a 50%, 75%, and 90% reduction of psoriasis severity (PASI 50, PASI 75, and PASI 90 response, respectively).
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week 12
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Physicians Global Assessment (PGA)
Time Frame: week 4
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Percentage of patients with plaque type psoriasis who experience an improvement in disease severity as defined by a PGA ≤ 1.
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week 4
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Physicians Global Assessment (PGA)
Time Frame: week 8
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Percentage of patients with plaque type psoriasis who experience an improvement in disease severity as defined by a PGA ≤ 1.
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week 8
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Physicians Global Assessment (PGA)
Time Frame: week 12
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Percentage of patients with plaque type psoriasis who experience an improvement in disease severity as defined by a PGA ≤ 1.
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week 12
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Change in Body surface area (BSA)
Time Frame: baseline and week 12
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Body surface area (BSA) mean and percent change from pre-treatment
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baseline and week 12
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Change in Dermatology Life Quality Index (DLQI)
Time Frame: baseline and at week 12
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DLQI mean (and percent) change from pre-treatment to Week 12
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baseline and at week 12
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safety of TSO
Time Frame: up to week 38
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The safety and tolerability of TSO will be evaluated via the frequency and severity of adverse events, changes in physical examinations, stool cultures, clinical laboratories, and vital signs.
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up to week 38
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 12-1881
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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