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

BioLineRx

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: BL-7040

Study type: Interventional

Funder types: Industry

Identifiers

NCT01506362

BL-7040.01

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

A synthetic oligonucleotide for treatment of IBD.

Experimental group

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.

Treatment:

Drug: BL-7040