NCT02768974

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Last Updated

September 28, 2016

Status Verified

May 1, 2016

Enrollment Period

5 months

First QC Date

March 27, 2016

Last Update Submit

September 26, 2016

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Adverse events following daily administration of OPRX 106

    Adverse events from subject reporting or other assessments

    70 days

Other Outcomes (5)

  • 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

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

    Baseline to day 56

  • +2 more other outcomes

Study Arms (2)

OPRX-106 2 mg

EXPERIMENTAL

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

Drug: OPRX-106

OPRX-106 8 mg

EXPERIMENTAL

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

Drug: OPRX-106

Interventions

OPRX-106DRUG

Oral delivery, once daily.

OPRX-106 2 mgOPRX-106 8 mg

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Soroka University Hospital

Beersheba, Israel

RECRUITING

Rambam Health Care Campus

Haifa, Israel

RECRUITING

Hadassah Medical Center

Jerusalem, Israel

NOT YET RECRUITING

Shaare-Zedek Medical Center

Jerusalem, Israel

NOT YET RECRUITING

Galilee Medical Center

Nahariya, Israel

NOT YET RECRUITING

Assaf-Harofeh Medical Center

Rishon LeZiyyon, Israel

NOT YET RECRUITING

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Einat Dekel, DVM

    Sr. Director Clinical Development

    STUDY DIRECTOR

Central Study Contacts

Einat Dekel, DVM

CONTACT

Einat.Dekel@protalix.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2016

First Posted

May 11, 2016

Study Start

September 1, 2016

Primary Completion

February 1, 2017

Last Updated

September 28, 2016

Record last verified: 2016-05

Locations

IL(7)