Safety, Tolerability, Efficacy Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative Colitis
Status:
Completed
Trial end date:
2015-06-20
Target enrollment:
Participant gender:
Summary
PUR 0110 is a 100% natural novel investigational medicinal product that has been demonstrated
in several in vitro and in vivo pharmacology studies to have potent anti-inflammatory,
anti-oxidative and immunomodulatory effects. This exploratory Phase 2a study is a
first-in-patient study to evaluate the safety, tolerability, biomarker effect and efficacy of
PUR 0110 rectal enema in patients with active mild-to-moderate distal ulcerative colitis
(UC).
The study is a multicenter, randomized, double-blind, parallel-group, dose-ranging,
placebo-controlled study. To be eligible for inclusion into the study, patients must either
be newly diagnosed or have on-going active mild-to-moderate distal ulcerative colitis of at
least 3 months duration confirmed in either case by flexible sigmoidoscopy and biopsy at the
Screening Visit. In addition, patients must have a modified Mayo score of ≥5 to ≤10 including
a sigmoidoscopy inflammation grade and rectal bleeding scores of ≥2 each. Eligible patients
will be randomly assigned to receive either PUR 0110 250 mg, 500 mg or 1000 mg or placebo
rectal enema in a 1:1:1:1 ratio. Patients will self-administer the assigned study medication
intrarectally once-daily at bedtime (10:00 p.m +/- 1 hour) for 2 weeks.
Patients will be evaluated for safety by adverse events, clinical laboratory tests, vital
signs, physical examination, electrocardiogram (ECG), and concomitant medications. Efficacy
evaluations will include the modified Mayo score, patient-defined response and remission,
Investigator Assessment of Ulcerative Colitis Symptom Score, Inflammatory Bowel Disease
Questionnaire (IBDQ), and biomarkers of inflammation, apoptosis and total cell death, lipid
peroxidation and in vivo oxidative stress, and antioxidant defense mechanisms in plasma,
serum, urine, feces and biopsy tissue. Patients will have a flexible sigmoidoscopy and biopsy
12 hours after the last dose of study medication.