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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02768974
• Other study ID #: PB-106-003
• Status: Recruiting
• Phase: Phase 2
• First received: March 27, 2016
• Last updated: September 26, 2016
• Start date: September 2016

Study information

• Verified date: May 2016
• Source: Protalix
• Contact: Einat Dekel, DVM
• Email: Einat.Dekel[@]protalix.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• OPRX-106
Oral delivery, once daily.

Locations

Country	Name	City	State
Israel	Soroka University Hospital	Be'er-Sheva
Israel	Rambam Health Care Campus	Haifa
Israel	Hadassah Medical Center	Jerusalem
Israel	Shaare-Zedek Medical Center	Jerusalem
Israel	Galilee Medical Center	Nahariya
Israel	Assaf-Harofeh Medical Center	Rishon Lezion
Israel	Tel-Aviv Sourasky Medical Center	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Protalix

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	OPRX-106 individual plasma levels following single and multiple dose administrations		56 days	No
Other	Clinical response or clinical remission from baseline to end of OPRX 106 treatment	Based on Mayo score	Baseline to day 56	No
Other	Histopathological improvement (Geboes scale) from baseline to end of OPRX treatment		Baseline to day 56	No
Other	Improvement from baseline to end of OPRX 106 treatment in hs-CRP levels		Baseline to day 56	No
Other	Improvement from baseline to end of OPRX 106 treatment in fecal calprotectin levels		Baseline to day 56	No
Primary	Adverse events following daily administration of OPRX 106	Adverse events from subject reporting or other assessments	70 days	Yes