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

Phase 2

• Conditions: Ulcerative Colitis
• Interventions: Drug: OPRX-106

• Registration Number: NCT02768974
• Lead Sponsor: Protalix

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-27
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-08
• Study First Posted: 2016-05-11
• Study Start: 2016-09
• Last Update Submitted: 2016-09-26
• Last Update Posted: 2016-09-28
• Primary Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OPRX-106 2 mg	OPRX-106	Open label, 1:1 randomization ration (up to 10 subjects)
OPRX-106 8 mg	OPRX-106	Open label, 1:1 randomization ration (up to 10 subjects)

Primary Outcome Measures

Name	Time	Method
Adverse events following daily administration of OPRX 106	70 days	Adverse events from subject reporting or other assessments

Trial Locations

Locations (7)

Soroka University Hospital; 🇮🇱 Be'er-Sheva, Israel

Rambam Health Care Campus; 🇮🇱 Haifa, Israel

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel

Galilee Medical Center; 🇮🇱 Nahariya, Israel

Assaf-Harofeh Medical Center; 🇮🇱 Rishon Lezion, Israel

Tel-Aviv Sourasky Medical Center; 🇮🇱 Tel-Aviv, Israel

Shaare-Zedek Medical Center; 🇮🇱 Jerusalem, Israel