Oral OKT3 for the Treatment of Active Ulcerative Colitis
This study will assess the safety and efficacy of orally delivered short-term OKT3 in patients with active ulcerative colitis.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Oral Anti-CD3 for the Treatment of Active Ulcerative Colitis|
- Oral OKT3 for the treatment of active ulcerative colitis. [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]adverse drug reaction
- Oral OKT3 for the Treatment of Active Ulcerative Colitis [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]immunologic assays
- Oral OKT3 for the Treatment of Active Ulcerative Colitis [ Time Frame: 5 weeks, 10 weeks ] [ Designated as safety issue: No ]Improvement in Mayo Score, Simple colitis activity index
- Oral OKT3 for the Treatment of Active Ulcerative Colitis [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]Improvement in histologic evaluation at flexible sigmoidoscopy
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Oral OKT3
Subjects will receive 1 mg or 2 mg OKT3 daily for 30 days given with Omeprazole 20 mg daily.
Drug: Oral OKT3
1 mg or 2 mg Oral OKT3 will be given orally to patients for 30 days with Omeprazole 20 mg daily.
Ulcerative colitis (UC) is a chronic disease of unknown etiology characterized by infiltration of inflammatory cells into the intestinal tract. OKT3 is an approved drug for intravenous use in the treatment of solid-organ transplantation. However, intravenous dosing has been limited by significant toxicities. Data from animal models suggest that anti-CD3 administered via the oral route is effective at treating a variety of autoimmune diseases. No side effects were observed in a recent phase I study of healthy subjects receiving oral anti-CD3 mAb.
The objectives of the current study are to assess the safety, immunologic effects and efficacy of short-term oral administration of OKT3 in patients with active ulcerative colitis . OKT3 will be delivered orally as a 1 mg or 2 mg dose with Omeprazole 20 mg daily for 30 consecutive days in an open-label pilot trial. Thirty two subjects will be screened for a targeted completion of 16 enrolled patients. The subjects will be evaluated at baseline, day 1, day 2, week 1, week 3, as well as after completion of therapy at week 5 and 10 after the initiation of treatment. Lab tests will be performed at screening, baseline, day 2, week 1, week 3, week 5 and week 10. Clinical data will be collected at all study visits and via diary entries throughout the study period. A flexible sigmoidoscopy will be done at baseline and at week 5. Stool studies will be performed at screening to rule out infection.
To be eligible for this study, subjects must be between the ages of 18 and 65 years and have a history of moderately to severely active UC as defined by a Mayo score of 6 to 12. They may not be taking concurrent biologic or immunomodulator therapy for UC.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287195
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Scott Snapper, MD, PhD||Brigham and Women's Hospital|