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

NCT ID: NCT01506362

Last Updated: 2014-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-05-31

Brief Summary

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

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A synthetic oligonucleotide for treatment of IBD.

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.

Group Type: EXPERIMENTAL

BL-7040

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioLineRx, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sigal Fishman, MD

Role: PRINCIPAL_INVESTIGATOR

Sourasky Medical Center

Eran Israeli, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Yehuda Chowers, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Eran Goldin, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center

Alex Fisch, MD

Role: PRINCIPAL_INVESTIGATOR

Soroka University Medical Center

Locations

Soroka Medical Center

Beersheba, , Israel

Rambam Medical Center

Haifa, , Israel

Hadassah medical center

Jerusalem, , Israel

Shaare Zedek Medical center

Jerusalem, , Israel

Sourasky Medical Center

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

BL-7040.01

Identifier Type: -

Identifier Source: org_study_id