Oral OKT3 for the Treatment of Active Ulcerative Colitis

• Status: Completed
• Trial end date: 2013-05-02
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety and efficacy of orally delivered short-term OKT3 in participants with active ulcerative colitis.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Muromonab-CD3; Omeprazole

Criteria

1.1 Inclusion Criteria

• Ability to provide informed consent

• Age between 18 and 65 years

• Confirmed diagnosis of UC for at least 3 months with the extent defined within the previous year

• Moderate to severe UC as defined by a Mayo score of 6-12

• Concomitant medications: Can be on 5-amino salicylate (5-ASA) medications and stable doses (same dose > 4 weeks) of oral steroids

• Concomitant medications cannot include Infliximab, Adalimumab, Certolizumab or Natalizumab for 4 weeks; rectal steroids, 6-mercaptopurine (6-MP), Azathioprine, Tacrolimus, Methotrexate, Thalidomide, Cellcept for 4 weeks; Theophylline, sulfonylureas, non-steroidal anti-inflammatory drug (NSAIDs) or aspirin for 10 days

• Negative serum pregnancy test within 2 weeks prior to receiving the first dose of study drug in female participants of child-bearing potential

• Female participants of child-bearing potential must be willing to use birth control during the study and for 4 weeks following the last dose of study drug.

1.2 Exclusion Criteria

• Crohn's disease or indeterminate colitis

• Mayo score of <6 (mild UC)

• Hospitalized or exhibiting signs of toxicity (abdominal distension, severe abdominal tenderness, fever, nausea, vomiting, or tachycardia)

• A history of colorectal cancer or colorectal dysplasia

• Pregnant or breastfeeding females or females wishing to become pregnant within the next 6 months or unwilling to use birth control

• Serum creatinine ≥ 2.0 milligrams per deciliter (mg/dL)

• Alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), or direct bilirubin >1.5x normal: elevated indirect bilirubin related to likely Gilbert's disease permissible

• Use of any of the following medications: Azathioprine, 6-MP, Methotrexate, Mycophenolate Mofetil, Tacrolimus, Cyclosporine, Thalidomide, Adalimumab, Infliximab, Certolizumab, Natalizumab, rectal steroids. Theophylline, sulfonylureas, NSAIDs or aspirin within 10 days of study enrollment

• Psychiatric illness or substance abuse that would interfere with ability to comply with protocol requirements or give informed consent

• Surgery within the last 3 months

• Prior gastrointestinal surgery

• Clinically significant infectious, immune mediated or malignant disease

• Receiving an elemental diet or parenteral nutrition

• History of coagulopathy

• Human immunodeficiency virus (HIV) positive

• Hepatitis B surface antigen (HBsAg) positive

• Active cytomegalovirus (CMV)

• Anemia: hemoglobin (Hb) < 8 grams/deciliter (g/dL). If the subject has known significant cardiac disease, subjects with Hb < 10.5 g/dL will be excluded.

• Thrombocytopenia (platelets < 100,000 per microliter [100K/mcL])

• Lymphopenia (absolute lymphocyte count <0.7)

• Immunoglobulin G (IgG) anti-cardiolipin antibody positive >16 International Units (IU)

• Prior exposure to OKT3

• Positive quantiferon gold, tuberculosis (TB) spot test, or purified protein derivative (PPD) test

• Known sensitivity to any ingredients in the study drug

• Anti-mouse antibody titer >1:1000

• Any known autoimmune disease except for ulcerative colitis

• Allergy or hypersensitivity to Omeprazole

• Participated in another clinical trial within 30 days of screening for this trial