Phase 2 N=6 Treatment

Oral OKT3 for the Treatment of Active Ulcerative Colitis

Ulcerative Colitis

Bottom Line

View on ClinicalTrials.gov: NCT01287195 ↗

Enrolled (actual)

Serious AEs

33.3%

Results posted

Jun 2017

Primary outcome: Primary: Number of Participants With Adverse Events — 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Oral OKT3 (Drug); Omeprazole (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Brigham and Women's Hospital
Primary completion: May 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events	3	—
PRIMARY Number of Participants With Anti-Drug Antibodies	—	—
PRIMARY Percentage of Biomarker-positive Immune Cells	38; 30; 59; 75; 31; 24	—
PRIMARY T Cell Proliferation of PBMCs in Cell Culture	27470; 49617; 46575; 20993	—
PRIMARY Cytokine Production by PBMCs in Cell Culture	4935; 11521; 10178; 2832; 69; 114	—
SECONDARY Mayo Score	8.8; 7.5	—
SECONDARY Simple Clinical Colitis Activity Index (SCCAI) Score	7.7; 6	—
SECONDARY Score in Histologic Evaluation of Flexible Sigmoidoscopy	2.2; 1.75	—

Summary

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

Eligibility 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 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) 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01287195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.