Efficacy, Pharmacodynamics, Safety and Tolerability of Oral BL-7040 in Patients With Moderately Active Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

An Open-Label Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of Oral BL-7040 in Patients With Moderately Active Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01506362
• Other study ID #: BL-7040.01
• Status: Completed
• Phase: Phase 2
• First received: January 3, 2012
• Last updated: July 1, 2014
• Start date: March 2012
• Est. completion date: May 2013

Study information

• Verified date: March 2014
• Source: BioLineRx, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The objective of the proposed study is to determine whether BL-7040 demonstrates clinical efficacy in patients with inflammatory bowel disease (IBD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Male or female, age 18 to 70.

2. Moderately active ulcerative colitis as defined by Mayo score of = 5 and = 9 within 9 days of first day of study treatment.

3. Diagnosis of ulcerative colitis = 3 months prior to study entry.

4. Endoscopic sub-score of = 2 and rectal bleeding sub-score of = 1 on the Mayo score and endoscopic evidence of disease activity a minimum of 20 cm from the anal verge, determined within 9 days of first day of study treatment.

5. Female patients must have a negative serum pregnancy test at screening and be willing and able to use a medically acceptable method of birth control or declare that they are abstaining from sexual intercourse, from the screening visit through the study termination visit or be surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or post-menopausal. Postmenopausal women are defined as women with menstruation cessation for 12 consecutive months prior to signing of the informed consent form.

6. Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment

Exclusion Criteria:

1. Diagnosis of indeterminate colitis or clinical findings suggestive of Crohn's disease.

2. Subjects with ulcerative proctitis.

3. A diagnosis of ischemic colitis, fulminant colitis or toxic megacolon.

4. Evidence of bowel infection.

5. Body temperature = 38°C at screening.

6. Evidence of abdominal abscess at the initial screening visit.

7. Extensive colonic resection, subtotal or total colectomy.

8. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.

9. Receiving non-permitted IBD therapies

10. History of or current peptic ulcer disease.

11. Pregnant or lactating women.

12. Chronic hepatitis B or C infection or HIV seropositivity.

13. Current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurological disease.

14. Drug or alcohol abuse (by history).

15. Patients participating in any other clinical trials.

16. Patients with inability to communicate well with the Investigators and staff (i.e., language problem, poor mental development or impaired cerebral function).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• BL-7040
BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems. Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up. BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days.

Locations

Country	Name	City	State
Israel	Soroka Medical Center	Be'er Sheva
Israel	Rambam Medical Center	Haifa
Israel	Hadassah medical center	Jerusalem
Israel	Shaare Zedek Medical center	Jerusalem
Israel	Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
BioLineRx, Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients Who After Study Completion Achieve Clinical Response Defined by at Least a 3point Decrease & 30% Reduction From Baseline in Mayo Score Plus = 1 Point Decrease in Rectal Bleeding Sub-score or Absolute Rectal Bleeding Subscore of = 1	Mayo score assesses stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment. It is assessed according to the following parameters: Stool frequency (subscore 0-3) 0: Normal number of stools for patient; 1 to 2 stools per day more than normal; 3 to 4 stools more than normal; > or = to 5 stools more than normal; Rectal bleeding (subscore 0-3) 0: No blood seen; Streaks of blood with stool less than half the time; Obvious blood with stool most of the time; Blood alone passes; Endoscopic findings (subscore 0-3) 0: Normal or inactive disease; 1 Mild Disease (erythema, decreased vascular pattern, mild friability) 2: Moderate Disease (marked erythema, lack of vascular pattern, friability erosions) 3: Severe Disease (spontaneous bleeding, ulceration); Physician's Global Assessment (subscore 0-3) 0: Normal; Mild disease; Moderate disease; Severe disease	From Baseline to day 34 (end of treatment period)	No
Secondary	Proportion of Patients With Mucosal Healing After Completion of Study Treatment Defined as Reduction in Endoscopy Subscore of = 1 From Baseline & an Absolute Endoscopy Subscore of = 1 Assessed by Flexible Sigmoidoscopy.		5 weeks following first administration	Yes