Ulcerative Colitis
Conditions
Brief 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.
Interventions
DRUGOPRX-106
Oral delivery, once daily.
Sponsors
Protalix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events following daily administration of OPRX 106 | 70 days | Adverse events from subject reporting or other assessments |
Other
| Measure | Time frame | Description |
|---|---|---|
| OPRX-106 individual plasma levels following single and multiple dose administrations | 56 days | — |
| Clinical response or clinical remission from baseline to end of OPRX 106 treatment | Baseline to day 56 | Based on Mayo score |
| Histopathological improvement (Geboes scale) from baseline to end of OPRX treatment | Baseline to day 56 | — |
| Improvement from baseline to end of OPRX 106 treatment in hs-CRP levels | Baseline to day 56 | — |
| Improvement from baseline to end of OPRX 106 treatment in fecal calprotectin levels | Baseline to day 56 | — |
Countries
Israel
Contacts
Primary ContactEinat Dekel, DVM
Outcome results
None listed