Trial record 1 of 1 for:    NCT01836939
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Safety and Effectiveness of CNDO 201Trichuris Suis Ova (TSO) for the Treatment of Moderate to Severe Plaque Psoriasis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Coronado Biosciences, Inc.
Information provided by (Responsible Party):
Mark Lebwohl, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01836939
First received: March 26, 2013
Last updated: December 30, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: TSO 2500
Drug: TSO 7500
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Psoriasis Area and Severity Index (PASI) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • psoriasis severity [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    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).

  • psoriasis severity [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    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).

  • psoriasis severity [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    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).

  • Physicians Global Assessment (PGA) [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    Percentage of patients with plaque type psoriasis who experience an improvement in disease severity as defined by a PGA ≤ 1.

  • Physicians Global Assessment (PGA) [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Percentage of patients with plaque type psoriasis who experience an improvement in disease severity as defined by a PGA ≤ 1.

  • Physicians Global Assessment (PGA) [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Percentage of patients with plaque type psoriasis who experience an improvement in disease severity as defined by a PGA ≤ 1.

  • Change in Body surface area (BSA) [ Time Frame: baseline and week 12 ] [ Designated as safety issue: No ]
    Body surface area (BSA) mean and percent change from pre-treatment

  • Change in Dermatology Life Quality Index (DLQI) [ Time Frame: baseline and at week 12 ] [ Designated as safety issue: No ]
    DLQI mean (and percent) change from pre-treatment to Week 12

  • safety of TSO [ Time Frame: up to week 38 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 8
Study Start Date: March 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TSO 2500
TSO 2500: 2500 embryonated, viable TSO/15 mL/day every 2 weeks X 10 weeks
Drug: TSO 2500
TSO 2500: 2500 embryonated, viable TSO/15 mL/day every 2 weeks X 10 weeks
Active Comparator: TSO 7500
TSO 7500: 7500 embryonated, viable TSO/15 mL/day every 2 weeks X 10 weeks
Drug: TSO 7500
12 weeks of treatment with TSO 2500 ova or TSO 7500 ova given every 2 weeks (a total of 6 doses).
Other Names:
  • CNDO 201 Trichuris suis ova (TSO)
  • Trichuris suis ova
  • TSO
  • CNDO 201 Trichuris suis ova

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

    1. Psoriasis covering a body surface area (BSA) ≥ 10%, and;
    2. PGA ≥ 3, and;
    3. 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:

    1. 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
    2. Surgically sterile (have had a hysterectomy or tubal ligation or otherwise be incapable of pregnancy), or
    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, 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
    4. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01836939

Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Mark Lebwohl
Coronado Biosciences, Inc.
Investigators
Principal Investigator: Mark Lebwohl, MD Mount Sinai School of Medicine
  More Information

Publications:
Responsible Party: Mark Lebwohl, Professor & Chair, Dermatology, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01836939     History of Changes
Other Study ID Numbers: GCO 12-1881
Study First Received: March 26, 2013
Last Updated: December 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mount Sinai School of Medicine:
psoriasis, oral therapy
ova
Trichuris suis ova
TSO
CNDO 201 Trichuris suis ova

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on September 14, 2014