Open Label Study to Assess Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis

Study Overview
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Brief Summary
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This is a proof of concept, randomized, open label, 2-arm study of OPRX-106 in subjects with active mild to moderate ulcerative colitis. Eligible subjects will be enrolled and randomized to receive 2 mg or 8 mg of OPRX-106 administered orally, once daily for 8 weeks.

Official Title
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An Open Label, Proof of Concept Study to Assess the Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: OPRX-106


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Have had a diagnosis of ulcerative colitis for a minimum of 3 months Have active mild to moderate ulcerative colitis, as defined by a full Mayo score at screening Have adequate cardiac, renal and hepatic functions as determined by the investigator and demonstrated by screening clinical and laboratory evaluations, and physical examination results High level of calprotectin (>100 mg/kg of stool) Main Exclusion Criteria: Have a history of colonic or rectal surgery other than hemorrhoidal surgery or appendectomy .Positive for active/ latent mycobacterium tuberculosis (TB) infection .Have a history of infection requiring administration of any IV antibiotic, antiviral or antifungal medication or any oral anti-infective agent Severe ulcerative colitis Ulcerative proctitis, defined as disease limited to less than 15 cm from the anal verge Use >4.8 g 5-ASA or equivalent Use of corticosteroid or 5-ASA enemas, foams, or suppositories Use of anti-inflammatory medications or natural remedies Use oral or parenteral antibiotics Use of chronic non-steroidal anti-inflammatory (NSAID) therapy Use of immune suppressive agents including anti-TNF agents, Azathioprine, 6MP, Methotrexate Use of steroids Have a diagnosis of: Crohn's disease; Indeterminate colitis; Microscopic colitis; Ischemic or infectious colitis; Clostridium difficile colitis, Parasitic disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPRX-106 2 mg<br>Open label, 1:1 randomization ration (up to 10 subjects) | Drug: OPRX-106<br>* Oral delivery, once daily.<br>|
| Experimental: OPRX-106 8 mg<br>Open label, 1:1 randomization ration (up to 10 subjects) | Drug: OPRX-106<br>* Oral delivery, once daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events following daily administration of OPRX 106 | Adverse events from subject reporting or other assessments | 70 days |