Trial Outcomes & Findings for Oral OKT3 for the Treatment of Active Ulcerative Colitis (NCT NCT01287195)

Last Updated: 2019-02-11

Results Overview

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

6 participants

Primary outcome timeframe

From baseline to Week 10

Results posted on

2019-02-11

Participant Flow

Participant milestones

Participant milestones
Measure	Oral OKT3 Participants with ulcerative colitis received 1 milligram (mg) Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
Overall Study STARTED	6
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Oral OKT3 Participants with ulcerative colitis received 1 milligram (mg) Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Oral OKT3 for the Treatment of Active Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral OKT3 n=6 Participants Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
Age, Continuous	39.5 years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline to Week 10

Population: All participants enrolled in the study.

Outcome measures

Outcome measures
Measure	Oral OKT3 n=6 Participants Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
Number of Participants With Adverse Events	3 Participants

PRIMARY outcome

Timeframe: From baseline to Week 10

Population: All participants enrolled in the study.

Serum samples were obtained to measure anti-drug antibodies during the study.

Outcome measures

Outcome measures
Measure	Oral OKT3 n=6 Participants Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
Number of Participants With Anti-Drug Antibodies	0 Participants

PRIMARY outcome

Timeframe: Baseline, Week 5

Population: All participants enrolled in the study for whom data were available at both time points.

Peripheral blood mononuclear cells were (PBMCs) were isolated from blood samples taken from each participant at baseline and Week 5. PBMCs were stained with a panel of fluorochrome-conjugated antibodies against multiple surface and intracellular biomarkers, including Cluster of Differentiation (CD) 3, CD4, CD8, Forkhead box P3 protein (FOXP3) and latency-associated peptide (LAP). The percentage of T cells positive for each of these biomarkers was determined by fluorescence activated cell sorting (FACS) and the mean percentage of positive T cells for each biomarker for all analyzed participants is reported.