Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01953354
• Date of registration: 24/09/2013
• Prospective Registration: Yes
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis
• Scientific title: A Prospective, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study of Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis and Its Effects on Mucosal Immune State and Microbiota
• Date of first enrolment: November 2013
• Target sample size: 16
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01953354
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Bana Jabri, MD, PhD
• Affiliation: University of Chicago

• Name: Stephen Hanauer, MD
• Affiliation: Northwestern University

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subject has provided written informed consent

2. Diagnosis of UC (newly diagnosed or established patients) as determined by medical
history, endoscopic and histological confirmation with the proximal disease extent
limited to the left colon (distal to the splenic flexure), and accessible by flexible
sigmoidoscopy. Patients with left-sided disease and the presence of a periappendiceal
red patch (limited cecal inflammation) will be eligible as long as there is no
intervening evidence of colitis between the cecal base and the upper boundary of
inflammation in the left colon.

3. Mayo score >/= 4, as scored at Screen 2

4. If taking the following medications at Screen 1, subjects must meet the following
criteria:

1. Oral Corticosteroids: stable treatment for at least 4 weeks prior to Day 0 with a
maximum dose equivalent to <\=15 mg/day of prednisone

2. Immunosuppressants (azathioprine (AZA) or 6-mercaptopurine (6-MP)): treatment for
at least 12 weeks with a stable dose, not exceeding 2.5 mg/kg/day of AZA or 1.5
mg/kg/day of 6-MP, during the 4 weeks prior to Day 0

3. Aminosalicylates: stable oral doses up to 4.8 g/day for at least 4 weeks prior to
Day 0.

Exclusion Criteria:

1. Subjects whose UC is anticipated to require surgical, endoscopic, or radiologic
intervention during study participation

2. Uncontrolled GI bleeding

3. Subjects who have disease limited to the rectum (maximum disease extent of less than
15 cm)

4. Women who are pregnant, breast-feeding, or planning to become pregnant during the
study. All women of childbearing potential must have a negative serum pregnancy test
at Screen 2 prior to randomization of treatment.

5. Women of childbearing potential not using adequate birth control measures (e.g., total
abstinence, oral contraceptives, intrauterine device, barrier method with spermicide,
surgical sterilization, Depo-Provera, or hormonal implants).

6. Current or recent serious systemic disorder including clinically significant
impairment in cardiac, pulmonary, liver, renal, endocrine, hematologic, or neurologic
function, based on investigator discretion

7. Subjects currently receiving the following concomitant medications:

1. Prednisone or its equivalent at unstable doses or at doses exceeding 15 mg/day
within 4 weeks prior to Day 0

2. Local steroids such as budesonide, Colifoam, or Predsol enemas within 2 weeks
prior to Screen 2

3. Topical therapies, either mesalamine or steroids, taken within 2 weeks of Screen
2

4. Non-steroidal anti-inflammatory drugs (NSAIDs), Cyclooxygenase (COX)-2
inhibitors, or aspirin >100 mg/day within 2 weeks prior to Screen 2

5. Tumor necrosis factor (TNF)-alpha inhibitors including but not limited to
infliximab (Remicade) or adalimumab (Humira) within 12 weeks of Day 0

6. Any biological agent within 12 weeks of Day 0

7. Metronidazole within 4 weeks of Day 0

8. Receipt of any investigational agent within the 12 weeks prior to Day 0

9. Antibacterial or oral antifungal agents within 4 weeks of Screen 2

10. Interferon (IFN) therapy

11. Anticoagulants

12. Methotrexate

8. Blood transfusion within the 12 weeks prior to Day 0

9. Presence of any of the following abnormal laboratory parameters at Screen 1:

1. Hemoglobin < 10.0 g/dL

2. White Blood Count (WBC) < 4,000 or > 20,000/L (equivalent to WBC < 4 or > 20
x109/L)

3. Platelets < 100,000 or > 800,000/L (equivalent to platelets < 100 or > 800
x109/L)

4. Total bilirubin > 1.5 × Upper limit of normal (ULN)

5. Alanine transaminase (ALT) > 2 × ULN

6. Aspartate transaminase (AST) > 2 × ULN

7. Alkaline phosphatase (ALK) > 1.5 × ULN

8. Gamma-glutamyl transferase (GGT) > 1.5 × ULN

9. Creatinine > 1.5 × ULN

10. History of drug or alcohol abuse within one year prior to Day 0

11. Inability to understand the nature and requirements of the study, or to comply with
the study procedures or planned schedule of study visits

12. Evidence of infection with human immunodeficiency virus (HIV), hepatitis B, or
hepatitis C

13. Active infection with C. difficile, bacterial enteric pathogens, or pathogenic
ova/parasites

14. History of malignancy within the last 5 years, except for resected basal or squamous
cell carcinoma, treated cervical dysplasia, or treated in situ cervical cancer Grade I

15. History of colonic dysplasia

16. Any social or medical condition that, in the opinion of the investigator, would
preclude provision of informed consent, make participation in the study unsafe,
complicate interpretation of study outcome data, or otherwise interfere with achieving
the study objectives.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Intervention(s)

Biological: Placebo

Biological: Trichuris suis ova (TSO)

Primary Outcome(s)

Percentage of Participants Who Achieved a Clinical Response at Week 12 [Time Frame: Week 12]

Secondary Outcome(s)

Time to Modified Clinical Response [Time Frame: From Baseline through the day that modified clinical response is reached. Week 16 is the last visit that the modified Mayo score is assessed.]

Percent of Participants With Colonoscopic Evidence of Visible Worm [Time Frame: From Day 0 through end of follow-up, up to 36 weeks]

Percent of Participants With Increase in Concurrent Ulcerative Colitis (UC) Medications or New Rescue Medications Added [Time Frame: From Day 0 through Week 16]

Percent of Participants With a Modified Clinical Response [Time Frame: From Day 0 through time of first clinical response or end of follow-up, whichever comes first, up to 12 Weeks]

Percent of Participants With Healed Colonic Mucosa at Week 12 [Time Frame: Week 12]

Percent of Participants Who Achieved Remission at Week 12 [Time Frame: Week 12]

Percent of Participants With Increase in Diarrhea [Time Frame: From Day 0 through end of follow-up, up to 36 weeks]

Secondary ID(s)

DAIT AUC02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Autoimmunity Centers of Excellence

Coronado Biosciences, Inc.

Results

• Results available: Yes
• Date Posted: 10/02/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01953354