Clinical trial NCT01506362: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
IBD
Lead sponsor: BioLineRx, Ltd.
Sponsor class: INDUSTRY
First posted: 2012-01-10
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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).

Primary outcomes:
measure: 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
timeFrame: From Baseline to day 34 (end of treatment period)
Secondary outcomes:
measure: 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.
timeFrame: 5 weeks following first administration
Other outcomes:
Locations:
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah medical center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
affiliation: Sourasky Medical Center
name: Sigal Fishman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Eran Israeli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Care Campus
name: Yehuda Chowers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaare Zedek Medical Center
name: Eran Goldin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Soroka University Medical Center
name: Alex Fisch, MD
role: PRINCIPAL_INVESTIGATOR
References: