Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
Collaborator:
Coronado Biosciences, Inc.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01953354
First received: September 24, 2013
Last updated: September 18, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to evaluate the safety and effectiveness of trichuris suis ova (TSO) in ulcerative colitis (UC). We will look at how TSO affects the body's immune response and if there are related changes in participants' UC.

The cause of UC is not well understood. It is believed to be caused from an abnormal immune response to the normal bacteria that live in the gut (intestines and colon). This response acts as an "attack" on the healthy tissue of the bowel by a person's own immune cells which leads to disease.

It is well known that autoimmune diseases such as IBD, asthma, diabetes, and multiple sclerosis are more common in industrialized, well-developed countries with better sanitation and hygiene, as in the United States. These "cleaner" environments reduce exposure to germs and parasites naturally found in the environment. This reduced exposure may trigger responses in the body that make people more prone to diseases such as UC. People in non-industrialized countries and the tropics, where parasites are common, rarely develop these diseases. This observation has led researchers to want to better understand the relationship between the lack of natural bacteria in the gut and the onset of autoimmune diseases like as UC.


Condition Intervention Phase
Colitis, Ulcerative
Biological: Trichuris suis ova (TSO)
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Percentage of Subjects who Achieve a Clinical Response [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
    Clinical response will be defined as a reduction in Mayo score of ≥ 3 and ≥ 30% reduction from baseline, along with either a decrease from baseline in rectal bleeding sub-score of > 1 point or absolute rectal bleeding score of 0 or 1.


Secondary Outcome Measures:
  • Percentage of Subjects in Each Study Arm Achieving Remission [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
    Percentage of subjects in each study arm who achieve a remission at Week 12, where remission is defined as Mayo score of ≤ 1 with absence of rectal bleeding and endoscopy score of 0 or 1.

  • Percentage of Subjects in Each Study Arm with Healed Colonic Tissue [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
    Percentage of subjects in each study arm with healed colonic mucosa at Week 12, where healed colonic mucosa is defined as a Mayo endoscopy score of 0 or 1.

  • Time to Reach a Modified Clinical Response [ Time Frame: Up to 12 Weeks ] [ Designated as safety issue: Yes ]
    Time to reach a modified clinical response, where modified clinical response is defined as a reduction in the modified Mayo score of ≥ 2 from baseline (i.e., minus the endoscopy component).

  • Percentage of Subjects Each Study Arm with Colonoscopic Evidence of a Visible Worm (luminal or attached) [ Time Frame: Baseline to Week 36 ] [ Designated as safety issue: No ]
  • Percentage of Subjects Each Study Arm with Increase in Diarrhea [ Time Frame: Baseline to Week 36 ] [ Designated as safety issue: Yes ]
    The percentage of subjects experiencing an increase in diarrhea, as measured by the Mayo Score's Stool Frequency score.

  • Percentage of Subjects in Each Study Arm Requiring Increased Medications to Treat UC [ Time Frame: Baseline to Week 36 ] [ Designated as safety issue: Yes ]
    Percentage of subjects who require dose-escalation of concurrent medications or need rescue medications to treat UC.


Estimated Enrollment: 120
Study Start Date: November 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TSO 7500 Biological: Trichuris suis ova (TSO)
TSO 7500: 7500 embryonated, viable TSO every 2 weeks x 10 weeks (6 total doses)
Other Name: T. suis ova
Placebo Comparator: Placebo Biological: Placebo
15 mL aqueous solution

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. 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. 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.
  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: NCT01953354

Contacts
Contact: Rose Arrieta, RN 312-695-5878

Locations
United States, California
Stanford University School of Medicine Recruiting
Palo Alto, California, United States, 94305
Contact: Narinder Bolaria    650-736-7081    nbolaria@stanford.edu   
Principal Investigator: Shamita B Shah, MD         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06510
Contact: Elizabeth Ruggiero    203-785-7573    elizabeth.ruggiero@yale.edu   
Principal Investigator: Ioannis (Yanni) Oikonomou, MD         
United States, Florida
University of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Reldy Riveron    305-243-6403    rriveron@med.miami.edu   
Contact: Diana Morillo       DMorillo@med.miami.edu   
Principal Investigator: Maria T. Abreu, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States
Contact: Theresa Catalano    773-834-8489    tshumard@medicine.bsd.uchicago.edu   
Principal Investigator: Joel Pekow, MD         
Northwestern University Feinberg School of Medicine Recruiting
Chicago, Illinois, United States
Contact: Rose Arrieta    312-695-5878    rarrieta@northwestern.edu   
Principal Investigator: Stephen Hanauer, MD         
United States, Iowa
University of Iowa Hospital Recruiting
Iowa City, Iowa, United States, 52242
Contact: Robin Thompson    319-356-3747    robin-thompson@uiowa.edu   
Contact: Betty Musgrave    319-353-7723    betty-musgrave@uiowa.edu   
Principal Investigator: Steven Polyak         
United States, Maryland
University of Maryland Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Guru Jambaulikar    410-706-3397    gjambaulikar@medicine.umaryland.edu   
Principal Investigator: Raymond Cross, MD         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Veronika Testa, BSN, RN, CCRC    617-636-2379    vtesta@tuftsmedicalcenter.org   
Principal Investigator: Harmony Allison, M.D., M.S., M.P.H.         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Denise Dahle    507-284-0535    Dahle.Denise2@Mayo.edu   
Contact: Jan U. Burnes, RN    507-266-4339    burnes.jan@mayo.edu   
Principal Investigator: Edward Loftus, Jr., MD         
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Fatiha Chabouni    212-746-5109    fac2005@med.cornell.edu   
Principal Investigator: Ellen Scherl, MD         
United States, North Carolina
Duke University Medical Center Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Stacey Smith    919-668-9870    stacey.d.smith@duke.edu   
Contact: Loranda Ross    919-681-2941    loranda.ross@duke.edu   
Principal Investigator: Jane Onken, MD, MHS         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Elaine Queener, LPN    216-444-5202    queenee@ccf.org   
Principal Investigator: Bo Shen, MD         
United States, Pennsylvania
Drexel University Not yet recruiting
Philadelphia, Pennsylvania, United States, 19103
Contact: Daryl Spruill    215-255-7877    Daryl.Spruill@DrexelMed.edu   
Principal Investigator: Neilanjan Nandi, MD         
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kim Goldby-Reffner, RN,BS,CCRC    412-648-9173    goldbyreffnerka@upmc.edu   
Principal Investigator: Jason M Swoger, MD, MPh         
United States, Tennessee
Vanderbilt University Not yet recruiting
Nashville, Tennessee, United States, 37212
Contact: Eric Howard    615-322-7403    eric.f.howard@vanderbilt.edu   
Principal Investigator: David A. Schwartz, MD         
United States, Texas
Baylor College of Medicine Not yet recruiting
Houston, Texas, United States, 77030
Contact: Guillermina Cruz    713-798-8220    Guillermina.cruz@bcm.edu   
Principal Investigator: Jason K. Hou, MD         
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Jody Mooney    206-341-1452    jody.mooney@vmmc.org   
Principal Investigator: Michael Chiorean, MD         
Sponsors and Collaborators
Coronado Biosciences, Inc.
Investigators
Study Chair: Stephen Hanauer, MD Northwestern University
Study Chair: Bana Jabri, MD, PhD University of Chicago
  More Information

No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01953354     History of Changes
Other Study ID Numbers: DAIT AUC02
Study First Received: September 24, 2013
Last Updated: September 18, 2014
Health Authority: United States: Food and Drug Administration
United States: National Institutes of Health

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Ulcerative colitis
UC
Inflammatory Bowel Disease
IBD
TSO
T. suis
Trichuris suis ova

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014