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Trial record 1 of 2 for:    OPRX-106
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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

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ClinicalTrials.gov Identifier: NCT02768974
Recruitment Status : Unknown
Verified May 2016 by Protalix.
Recruitment status was:  Recruiting
First Posted : May 11, 2016
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
Protalix

Tracking Information
First Submitted Date  ICMJE March 27, 2016
First Posted Date  ICMJE May 11, 2016
Last Update Posted Date September 28, 2016
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2016)
Adverse events following daily administration of OPRX 106 [ Time Frame: 70 days ]
Adverse events from subject reporting or other assessments
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: May 8, 2016)
  • OPRX-106 individual plasma levels following single and multiple dose administrations [ Time Frame: 56 days ]
  • Clinical response or clinical remission from baseline to end of OPRX 106 treatment [ Time Frame: Baseline to day 56 ]
    Based on Mayo score
  • Histopathological improvement (Geboes scale) from baseline to end of OPRX treatment [ Time Frame: Baseline to day 56 ]
  • Improvement from baseline to end of OPRX 106 treatment in hs-CRP levels [ Time Frame: Baseline to day 56 ]
  • Improvement from baseline to end of OPRX 106 treatment in fecal calprotectin levels [ Time Frame: Baseline to day 56 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Open Label Study to Assess Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE Drug: OPRX-106
Oral delivery, once daily.
Study Arms  ICMJE
  • Experimental: OPRX-106 2 mg
    Open label, 1:1 randomization ration (up to 10 subjects)
    Intervention: Drug: OPRX-106
  • Experimental: OPRX-106 8 mg
    Open label, 1:1 randomization ration (up to 10 subjects)
    Intervention: Drug: OPRX-106
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 8, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02768974
Other Study ID Numbers  ICMJE PB-106-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Protalix
Study Sponsor  ICMJE Protalix
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Einat Dekel, DVM Sr. Director Clinical Development
PRS Account Protalix
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP