A clinical trial is being conducted to test the effects of a potential new treatment in patients with ulcerative colitis. Study participants will be given capsules containing either ORE1001 or a matching placebo capsule and will take the medicine by mouth for six weeks. Study participants will be asked to visit clinic sites where they will be asked questions about their ulcerative colitis. Small samples of blood will be be drawn at study visits to monitor the participant's health and a tiny sample of tissue will be taken in an endoscopy at two times to determine whether the disease is getting better or worse.
This is a Phase Ib/IIa prospective, multicenter, double blind, randomized, placebo controlled, clinical study to evaluate the safety, tolerability and pilot therapeutic activity of ORE1001, administered as capsules by mouth, for 6 weeks in subjects with Ulcerative Colitis. Eligible subjects will be randomly assigned to either ORE1001 or placebo, respectively. Sigmoidoscopies with biopsies will be performed at the first treatment visit and week 6. Subjects will be instructed to self-administer the study drug on an outpatient basis and will be scheduled to return for clinical evaluation on weeks 2, 4, 6 and between Weeks 10-12.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Robarts Research Institute
London, Ontario, Canada
RECRUITINGDr, Bhatnagar's Clinic
Ahmedabad, Gujarat, India
RECRUITINGVikram Jyoth Centre for Advanced Gastroenterology
Mysore, Karnataka, India
RECRUITINGSt. John's Medical College Hospital
Bangalore, Karnatka, India
RECRUITINGGut-n-HEPA Care
Indore, Madhya Pradesh, India
RECRUITINGAmol Gastroenterology Hospital
Indore, Madhya Pradesh, India
RECRUITINGB.Y.L. Nair Hospital
Bombay, Maharashtra, India
RECRUITINGThe safety and tolerability of ORE1001 in subjects with ulcerative colitis as demonstrated by the frequency and severity of adverse events
Time frame: 6 Week
Change in the modified Baron Score from Baseline to Week 6
Time frame: 6 Week
Change in the Ulcerative Colitis Clinical Score from Baseline
Time frame: 6 Week
Change in the partial Mayo Score fom baseline
Time frame: 6 week
Calprotectin concentrations
Time frame: 6 week
Riley Acute Inflammation Scale (histology)
Time frame: 6 week
Clinical remission
Time frame: Week 6
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