drugset / Trial / NCT01953354
Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis
Phase 2
Terminated
16 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Autoimmunity Centers of Excellence · collabCoronado Biosciences, Inc. · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2013-11
- Primary completion
- 2015-11
- Completion
- 2015-11
Outcome
Missed primary endpoint
Stopped (Business): “MFR's business decision to d/c TSO production -unrelated to any safety concern.”
registry analysis (superiority or other test); TSO 7500 vs Placebo; p = 1.000; Fisher Exact; NCT01953354 ↗
Publications
- Background 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trichuris suis ova (TSO) | Unknown | — | Oral |