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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

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: OPRX-106 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2016
Estimated Primary Completion Date : February 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Adverse events following daily administration of OPRX 106 [ Time Frame: 70 days ]
    Adverse events from subject reporting or other assessments


Other Outcome Measures:
  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 [ Time Frame: Baseline to day 56 ]
    Based on Mayo score

  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02768974


Contacts
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Contact: Einat Dekel, DVM Einat.Dekel@protalix.com

Locations
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Israel
Soroka University Hospital Recruiting
Be'er-Sheva, Israel
Contact: Alexander Fich, MD, Prof.         
Rambam Health Care Campus Recruiting
Haifa, Israel
Contact: Mattitiahu Waterman, MD         
Hadassah Medical Center Not yet recruiting
Jerusalem, Israel
Contact: Eran Israeli, MD         
Shaare-Zedek Medical Center Not yet recruiting
Jerusalem, Israel
Contact: Eran Goldin, MD, Prof.         
Galilee Medical Center Not yet recruiting
Nahariya, Israel
Contact: Wisam Sbeit, MD         
Assaf-Harofeh Medical Center Not yet recruiting
Rishon Lezion, Israel
Contact: Haim Shirin, MD, Prof.         
Tel-Aviv Sourasky Medical Center Recruiting
Tel-Aviv, Israel
Contact: Sigal Fishman, MD         
Sponsors and Collaborators
Protalix
Investigators
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Study Director: Einat Dekel, DVM Sr. Director Clinical Development

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Responsible Party: Protalix
ClinicalTrials.gov Identifier: NCT02768974     History of Changes
Other Study ID Numbers: PB-106-003
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases