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Status unknownNCT02768974Updated Sep 28, 2016

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

A Phase 2 interventional study of OPRX-106 in Ulcerative Colitis, sponsored by Protalix. Status unknown at 7 sites in Israel. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-09-28.

Sponsored by Protalix · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ulcerative Colitis
03

In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 771 interventional studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

Protalix is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    OPRX-106 2 mg

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

    Drug: OPRX-106

  • Experimental
    OPRX-106 8 mg

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

    Drug: OPRX-106

Interventions

  • DrugOPRX-106

    Oral delivery, once daily.

06

What researchers measure

Primary outcomes

  1. Adverse events following daily administration of OPRX 106

    Adverse events from subject reporting or other assessments

    Time frame: 70 days

Other outcomes

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

    Time frame: 56 days

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

    Based on Mayo score

    Time frame: Baseline to day 56

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

    Time frame: Baseline to day 56

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

    Time frame: Baseline to day 56

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

    Time frame: Baseline to day 56

07

Study locations

3 of 7 sites recruiting
  • Soroka University Hospital
    Be'er-Sheva, Israel
    • Alexander Fich, MD, Prof. · Contact
    Recruiting
  • Rambam Health Care Campus
    Haifa, Israel
    • Mattitiahu Waterman, MD · Contact
    Recruiting
  • Hadassah Medical Center
    Jerusalem, Israel
    • Eran Israeli, MD · Contact
    Not yet recruiting
  • Shaare-Zedek Medical Center
    Jerusalem, Israel
    • Eran Goldin, MD, Prof. · Contact
    Not yet recruiting
  • Galilee Medical Center
    Nahariya, Israel
    • Wisam Sbeit, MD · Contact
    Not yet recruiting
  • Assaf-Harofeh Medical Center
    Rishon Lezion, Israel
    • Haim Shirin, MD, Prof. · Contact
    Not yet recruiting
  • Tel-Aviv Sourasky Medical Center
    Tel-Aviv, Israel
    • Sigal Fishman, MD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02768974
Lead sponsor
Protalix
Responsible party
Sponsor
First posted
May 11, 2016
Start date
Sep 2016
Primary completion
Feb 2017 (estimated)
Last update
Sep 28, 2016

Study contacts

Einat Dekel, DVM
Contact
Einat.Dekel@protalix.com
Einat Dekel, DVM
study director · Sr. Director Clinical Development

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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