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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01836939
• Date of registration: 26/03/2013
• Prospective Registration: No
• Primary sponsor: Mark Lebwohl
• Public title: Safety and Effectiveness of CNDO 201Trichuris Suis Ova (TSO) for the Treatment of Moderate to Severe Plaque Psoriasis
• Scientific 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
• Date of first enrolment: March 2013
• Target sample size: 8
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01836939
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Mark Lebwohl, MD
• Affiliation: Mount Sinai School of Medicine

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Psoriasis

Intervention(s)

Drug: TSO 7500

Drug: TSO 2500

Primary Outcome(s)

Psoriasis Area and Severity Index (PASI) [Time Frame: up to 12 weeks]

Secondary Outcome(s)

Change in Body surface area (BSA) [Time Frame: baseline and week 12]

Change in Dermatology Life Quality Index (DLQI) [Time Frame: baseline and at week 12]

safety of TSO [Time Frame: up to week 38]

Physicians Global Assessment (PGA) [Time Frame: week 8]

Physicians Global Assessment (PGA) [Time Frame: week 12]

psoriasis severity [Time Frame: week 4]

psoriasis severity [Time Frame: week 8]

psoriasis severity [Time Frame: week 12]

Physicians Global Assessment (PGA) [Time Frame: week 4]

Secondary ID(s)

GCO 12-1881

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Coronado Biosciences, Inc.