Clinical trial NCT02768974: Open Label Study to Assess Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: Protalix
Sponsor class: INDUSTRY
First posted: 2016-05-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Adverse events following daily administration of OPRX 106
timeFrame: 70 days
Secondary outcomes:
Other outcomes:
measure: OPRX-106 individual plasma levels following single and multiple dose administrations
timeFrame: 56 days
measure: Clinical response or clinical remission from baseline to end of OPRX 106 treatment
timeFrame: Baseline to day 56
measure: Histopathological improvement (Geboes scale) from baseline to end of OPRX treatment
timeFrame: Baseline to day 56
measure: Improvement from baseline to end of OPRX 106 treatment in hs-CRP levels
timeFrame: Baseline to day 56
measure: Improvement from baseline to end of OPRX 106 treatment in fecal calprotectin levels
timeFrame: Baseline to day 56
Locations:
city: Be'er-Sheva
country: Israel
facility: Soroka University Hospital
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Jerusalem
country: Israel
facility: Shaare-Zedek Medical Center
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Rishon Lezion
country: Israel
facility: Assaf-Harofeh Medical Center
city: Tel-Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
Study officials:
affiliation: Sr. Director Clinical Development
name: Einat Dekel, DVM
role: STUDY_DIRECTOR
References: