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

Phase 2

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: BL-7040

• Registration Number: NCT01506362
• Lead Sponsor: BioLineRx, Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-03
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-10
• Study Start: 2012-03
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-03
• Results First Submitted: 2014-03-31
• Results First Submitted QC: 2014-03-31
• Results First Posted: 2014-05-01
• Last Update Submitted: 2014-07-01
• Last Update Posted: 2014-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A synthetic oligonucleotide for treatment of IBD.	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.

Primary Outcome Measures

Name	Time	Method
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	From Baseline to day 34 (end of treatment period)	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. 1 to 2 stools per day more than normal; 2. 3 to 4 stools more than normal; 3. \> or = to 5 stools more than normal; Rectal bleeding (subscore 0-3) 0: No blood seen; 1. Streaks of blood with stool less than half the time; 2. Obvious blood with stool most of the time; 3. 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; 1. Mild disease; 2. Moderate disease; 3. Severe disease

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Shaare Zedek Medical center; 🇮🇱 Jerusalem, Israel

Hadassah medical center; 🇮🇱 Jerusalem, Israel

Soroka Medical Center; 🇮🇱 Be'er Sheva, Israel

Rambam Medical Center; 🇮🇱 Haifa, Israel

Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel