Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis

NCT01953354 | Terminated Phase 2 Results DMC

• 1 other identifier: DAIT AUC02
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Colitis, Ulcerative

Keywords

Ulcerative colitis (UC); Inflammatory Bowel Disease (IBD); Trichuris suis ova (TSO)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved a Clinical Response at Week 12

  Clinical response is defined as a reduction in the Mayo score of at least 3 points and at least a 30% reduction from Baseline, along with either a decrease from Baseline in the rectal bleeding subscore of more than 1 point or a rectal bleeding subscore of 0 or 1.

  Week 12

Secondary Outcomes (7)

• Percent of Participants Who Achieved Remission at Week 12

  Week 12

• Percent of Participants With Healed Colonic Mucosa at Week 12

  Week 12

• Percent of Participants With a Modified Clinical Response

  From Day 0 through time of first clinical response or end of follow-up, whichever comes first, up to 12 Weeks

• Time to Modified Clinical Response

  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

  From Day 0 through end of follow-up, up to 36 weeks

Study Arms (2)

Trichuris suis ova (TSO)

EXPERIMENTAL

Six doses of TSO orally over a ten-week period

Biological: Trichuris suis ova (TSO)

Placebo

PLACEBO COMPARATOR

Six doses of TSO placebo orally over a ten-week period

Biological: Placebo

Interventions

Trichuris suis ova (TSO) BIOLOGICAL

Six doses of TSO orally over a ten-week period (e.g., every 2 weeks x 10 weeks for a total of 6 total doses)

Also known as: T. suis ova, 7500 Trichuris suis ova (7500 TSO ), CNDO 201

Trichuris suis ova (TSO)

Placebo BIOLOGICAL

Six doses of TSO placebo orally over a ten-week period (e.g., every 2 weeks x 10 weeks for a total of 6 total doses)

Also known as: Trichuris suis ova (TSO) placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has provided written informed consent
• 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.
• Mayo score \>/= 4, as scored at Screen 2
• If taking the following medications at Screen 1, subjects must meet the following criteria:
• Oral Corticosteroids: stable treatment for at least 4 weeks prior to Day 0 with a maximum dose equivalent to \<\\=15 mg/day of prednisone
• 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
• Aminosalicylates: stable oral doses up to 4.8 g/day for at least 4 weeks prior to Day 0.

You may not qualify if:

• Subjects whose UC is anticipated to require surgical, endoscopic, or radiologic intervention during study participation
• Uncontrolled GI bleeding
• Subjects who have disease limited to the rectum (maximum disease extent of less than 15 cm)
• 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.
• 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).
• Current or recent serious systemic disorder including clinically significant impairment in cardiac, pulmonary, liver, renal, endocrine, hematologic, or neurologic function, based on investigator discretion
• Subjects currently receiving the following concomitant medications:
• Prednisone or its equivalent at unstable doses or at doses exceeding 15 mg/day within 4 weeks prior to Day 0
• Local steroids such as budesonide, Colifoam, or Predsol enemas within 2 weeks prior to Screen 2
• Topical therapies, either mesalamine or steroids, taken within 2 weeks of Screen 2
• Non-steroidal anti-inflammatory drugs (NSAIDs), Cyclooxygenase (COX)-2 inhibitors, or aspirin \>100 mg/day within 2 weeks prior to Screen 2
• Tumor necrosis factor (TNF)-alpha inhibitors including but not limited to infliximab (Remicade) or adalimumab (Humira) within 12 weeks of Day 0
• Any biological agent within 12 weeks of Day 0
• Metronidazole within 4 weeks of Day 0
• Receipt of any investigational agent within the 12 weeks prior to Day 0

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Coronado Biosciences, Inc.: collaborator
• Autoimmunity Centers of Excellence: collaborator

Study Sites (17)

Stanford University School of Medicine

Palo Alto, California, 94305, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Iowa Hospital

Iowa City, Iowa, 52242, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Drexel University

Philadelphia, Pennsylvania, 19103, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University

Nashville, Tennessee, 37212, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Related Publications (3)

• Summers RW, Elliott DE, Qadir K, Urban JF Jr, Thompson R, Weinstock JV. Trichuris suis seems to be safe and possibly effective in the treatment of inflammatory bowel disease. Am J Gastroenterol. 2003 Sep;98(9):2034-41. doi: 10.1111/j.1572-0241.2003.07660.x.

  PMID: 14499784 BACKGROUND

• Moreels TG, Pelckmans PA. Gastrointestinal parasites: potential therapy for refractory inflammatory bowel diseases. Inflamm Bowel Dis. 2005 Feb;11(2):178-84. doi: 10.1097/00054725-200502000-00012.

  PMID: 15677912 BACKGROUND

• Baumgart DC, Carding SR. Inflammatory bowel disease: cause and immunobiology. Lancet. 2007 May 12;369(9573):1627-40. doi: 10.1016/S0140-6736(07)60750-8.

  PMID: 17499605 BACKGROUND

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID) website

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Limitations and Caveats

Recruitment was slower than anticipated. The study was ultimately terminated when the manufacturer decided to discontinue study product production.

Results Point of Contact

• Title: Director, Clinical Research Operations Program
• Organization: DAIT/NIAID

DAITClinicalTrialsGov@niaid.nih.gov

301-594-7669

Study Officials

• Stephen Hanauer, MD

  Northwestern University

  STUDY CHAIR

• Bana Jabri, MD, PhD

  University of Chicago

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: October 1, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 17, 2017
• Results First Posted: February 10, 2017

Record last verified: 2017-02

Locations

US (17)