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

Primary Purpose

Ulcerative Colitis

Status

Unknown status

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

OPRX-106

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

Have had a diagnosis of ulcerative colitis for a minimum of 3 months
Have active mild to moderate ulcerative colitis, as defined by a full Mayo score at screening
Have adequate cardiac, renal and hepatic functions as determined by the investigator and demonstrated by screening clinical and laboratory evaluations, and physical examination results
High level of calprotectin (>100 mg/kg of stool)

Main Exclusion Criteria:

Have a history of colonic or rectal surgery other than hemorrhoidal surgery or appendectomy
.Positive for active/ latent mycobacterium tuberculosis (TB) infection
.Have a history of infection requiring administration of any IV antibiotic, antiviral or antifungal medication or any oral anti-infective agent
Severe ulcerative colitis
Ulcerative proctitis, defined as disease limited to less than 15 cm from the anal verge
Use >4.8 g 5-ASA or equivalent
Use of corticosteroid or 5-ASA enemas, foams, or suppositories
Use of anti-inflammatory medications or natural remedies
Use oral or parenteral antibiotics
Use of chronic non-steroidal anti-inflammatory (NSAID) therapy
Use of immune suppressive agents including anti-TNF agents, Azathioprine, 6MP, Methotrexate
Use of steroids
Have a diagnosis of: Crohn's disease; Indeterminate colitis; Microscopic colitis; Ischemic or infectious colitis; Clostridium difficile colitis, Parasitic disease

Sites / Locations

Soroka University HospitalRecruiting
Rambam Health Care CampusRecruiting
Hadassah Medical Center
Shaare-Zedek Medical Center
Galilee Medical Center
Assaf-Harofeh Medical Center
Tel-Aviv Sourasky Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

OPRX-106 2 mg

OPRX-106 8 mg

Arm Description

Open label, 1:1 randomization ration (up to 10 subjects)

Outcomes

Primary Outcome Measures

Adverse events following daily administration of OPRX 106

Adverse events from subject reporting or other assessments

Secondary Outcome Measures

Full Information

NCT ID

NCT02768974

First Posted

March 27, 2016

Last Updated

September 26, 2016

Sponsor

Protalix

1. Study Identification

Unique Protocol Identification Number

NCT02768974

Brief Title

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

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Unknown status

Study Start Date

September 2016 (undefined)

Primary Completion Date

February 2017 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Protalix

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

OPRX-106 2 mg

Arm Type

Experimental

Arm Description

Open label, 1:1 randomization ration (up to 10 subjects)

Arm Title

OPRX-106 8 mg

Arm Type

Experimental

Arm Description

Open label, 1:1 randomization ration (up to 10 subjects)

Intervention Type

Drug

Intervention Name(s)

OPRX-106

Intervention Description

Oral delivery, once daily.

Primary Outcome Measure Information:

Title

Adverse events following daily administration of OPRX 106

Description

Adverse events from subject reporting or other assessments

Time Frame

70 days

Other Pre-specified Outcome Measures:

Title

OPRX-106 individual plasma levels following single and multiple dose administrations

Time Frame

56 days

Title

Clinical response or clinical remission from baseline to end of OPRX 106 treatment

Description

Based on Mayo score

Time Frame

Baseline to day 56

Title

Histopathological improvement (Geboes scale) from baseline to end of OPRX treatment

Time Frame

Baseline to day 56

Title

Improvement from baseline to end of OPRX 106 treatment in hs-CRP levels

Time Frame

Baseline to day 56

Title

Improvement from baseline to end of OPRX 106 treatment in fecal calprotectin levels

Time Frame

Baseline to day 56

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Main Inclusion Criteria: Have had a diagnosis of ulcerative colitis for a minimum of 3 months Have active mild to moderate ulcerative colitis, as defined by a full Mayo score at screening Have adequate cardiac, renal and hepatic functions as determined by the investigator and demonstrated by screening clinical and laboratory evaluations, and physical examination results High level of calprotectin (>100 mg/kg of stool) Main Exclusion Criteria: Have a history of colonic or rectal surgery other than hemorrhoidal surgery or appendectomy .Positive for active/ latent mycobacterium tuberculosis (TB) infection .Have a history of infection requiring administration of any IV antibiotic, antiviral or antifungal medication or any oral anti-infective agent Severe ulcerative colitis Ulcerative proctitis, defined as disease limited to less than 15 cm from the anal verge Use >4.8 g 5-ASA or equivalent Use of corticosteroid or 5-ASA enemas, foams, or suppositories Use of anti-inflammatory medications or natural remedies Use oral or parenteral antibiotics Use of chronic non-steroidal anti-inflammatory (NSAID) therapy Use of immune suppressive agents including anti-TNF agents, Azathioprine, 6MP, Methotrexate Use of steroids Have a diagnosis of: Crohn's disease; Indeterminate colitis; Microscopic colitis; Ischemic or infectious colitis; Clostridium difficile colitis, Parasitic disease

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Einat Dekel, DVM

Einat.Dekel@protalix.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Einat Dekel, DVM

Organizational Affiliation

Sr. Director Clinical Development

Official's Role

Study Director

Facility Information:

Facility Name

Soroka University Hospital

City

Be'er-Sheva

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexander Fich, MD, Prof.

Facility Name

Rambam Health Care Campus

City

Haifa

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mattitiahu Waterman, MD

Facility Name

Hadassah Medical Center

City

Jerusalem

Country

Israel

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eran Israeli, MD

Facility Name

Shaare-Zedek Medical Center

City

Jerusalem

Country

Israel

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eran Goldin, MD, Prof.

Facility Name

Galilee Medical Center

City

Nahariya

Country

Israel

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wisam Sbeit, MD

Facility Name

Assaf-Harofeh Medical Center

City

Rishon Lezion

Country

Israel

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Haim Shirin, MD, Prof.

Facility Name

Tel-Aviv Sourasky Medical Center

City

Tel-Aviv

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sigal Fishman, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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