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

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

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.

Study Overview

• Status: Unknown
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: OPRX-106

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Einat Dekel, DVM; Email: Einat.Dekel@protalix.com

Study Locations

• Israel
  • Be'er-Sheva, Israel
    • Recruiting
    • Soroka University Hospital
    • Contact: Alexander Fich, MD, Prof.
  • Haifa, Israel
    • Recruiting
    • Rambam Health Care Campus
    • Contact: Mattitiahu Waterman, MD
  • Jerusalem, Israel
    • Not yet recruiting
    • Hadassah Medical Center
    • Contact: Eran Israeli, MD
  • Jerusalem, Israel
    • Not yet recruiting
    • Shaare-Zedek Medical Center
    • Contact: Eran Goldin, MD, Prof.
  • Nahariya, Israel
    • Not yet recruiting
    • Galilee Medical Center
    • Contact: Wisam Sbeit, MD
  • Rishon Lezion, Israel
    • Not yet recruiting
    • Assaf-Harofeh Medical Center
    • Contact: Haim Shirin, MD, Prof.
  • Tel-Aviv, Israel
    • Recruiting
    • Tel-Aviv Sourasky Medical Center
    • Contact: Sigal Fishman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Based on Mayo score	Baseline to day 56
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

Collaborators and Investigators

• Sponsor: Protalix
• Investigators: Study Director: Einat Dekel, DVM, Sr. Director Clinical Development

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: March 27, 2016
• First Submitted That Met QC Criteria: May 8, 2016
• First Posted (Estimate): May 11, 2016

Study Record Updates

• Last Update Posted (Estimate): September 28, 2016
• Last Update Submitted That Met QC Criteria: September 26, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: PB-106-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided