Overview

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

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Protalix
Criteria
Main Inclusion Criteria:

1. Have had a diagnosis of ulcerative colitis for a minimum of 3 months

2. Have active mild to moderate ulcerative colitis, as defined by a full Mayo score at
screening

3. Have adequate cardiac, renal and hepatic functions as determined by the investigator
and demonstrated by screening clinical and laboratory evaluations, and physical
examination results

4. High level of calprotectin (>100 mg/kg of stool)

Main Exclusion Criteria:

1. Have a history of colonic or rectal surgery other than hemorrhoidal surgery or
appendectomy

2. .Positive for active/ latent mycobacterium tuberculosis (TB) infection

3. .Have a history of infection requiring administration of any IV antibiotic, antiviral
or antifungal medication or any oral anti-infective agent

4. Severe ulcerative colitis

5. Ulcerative proctitis, defined as disease limited to less than 15 cm from the anal
verge

6. Use >4.8 g 5-ASA or equivalent

7. Use of corticosteroid or 5-ASA enemas, foams, or suppositories

8. Use of anti-inflammatory medications or natural remedies

9. Use oral or parenteral antibiotics

10. Use of chronic non-steroidal anti-inflammatory (NSAID) therapy

11. Use of immune suppressive agents including anti-TNF agents, Azathioprine, 6MP,
Methotrexate

12. Use of steroids

13. Have a diagnosis of: Crohn's disease; Indeterminate colitis; Microscopic colitis;
Ischemic or infectious colitis; Clostridium difficile colitis, Parasitic disease