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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

BL-7040

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, IBD

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female, age 18 to 70.
Moderately active ulcerative colitis as defined by Mayo score of ≥ 5 and ≤ 9 within 9 days of first day of study treatment.
Diagnosis of ulcerative colitis ≥ 3 months prior to study entry.
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.
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.
Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment

Exclusion Criteria:

Diagnosis of indeterminate colitis or clinical findings suggestive of Crohn's disease.
Subjects with ulcerative proctitis.
A diagnosis of ischemic colitis, fulminant colitis or toxic megacolon.
Evidence of bowel infection.
Body temperature ≥ 38°C at screening.
Evidence of abdominal abscess at the initial screening visit.
Extensive colonic resection, subtotal or total colectomy.
Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
Receiving non-permitted IBD therapies
History of or current peptic ulcer disease.
Pregnant or lactating women.
Chronic hepatitis B or C infection or HIV seropositivity.
Current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurological disease.
Drug or alcohol abuse (by history).
Patients participating in any other clinical trials.
Patients with inability to communicate well with the Investigators and staff (i.e., language problem, poor mental development or impaired cerebral function).

Sites / Locations

Soroka Medical Center
Rambam Medical Center
Hadassah medical center
Shaare Zedek Medical center
Sourasky Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A synthetic oligonucleotide for treatment of IBD.

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01506362

First Posted

January 3, 2012

Last Updated

July 1, 2014

Sponsor

BioLineRx, Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01506362

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BioLineRx, Ltd.

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

Keywords

Ulcerative Colitis, IBD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A synthetic oligonucleotide for treatment of IBD.

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

BL-7040

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

From Baseline to day 34 (end of treatment period)

Secondary Outcome Measure Information:

Title

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.

Time Frame

5 weeks following first administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Male or female, age 18 to 70. Moderately active ulcerative colitis as defined by Mayo score of ≥ 5 and ≤ 9 within 9 days of first day of study treatment. Diagnosis of ulcerative colitis ≥ 3 months prior to study entry. 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. 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. Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment Exclusion Criteria: Diagnosis of indeterminate colitis or clinical findings suggestive of Crohn's disease. Subjects with ulcerative proctitis. A diagnosis of ischemic colitis, fulminant colitis or toxic megacolon. Evidence of bowel infection. Body temperature ≥ 38°C at screening. Evidence of abdominal abscess at the initial screening visit. Extensive colonic resection, subtotal or total colectomy. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine. Receiving non-permitted IBD therapies History of or current peptic ulcer disease. Pregnant or lactating women. Chronic hepatitis B or C infection or HIV seropositivity. Current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurological disease. Drug or alcohol abuse (by history). Patients participating in any other clinical trials. Patients with inability to communicate well with the Investigators and staff (i.e., language problem, poor mental development or impaired cerebral function).

Overall Study Officials: