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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioLineRx, Ltd.
ClinicalTrials.gov Identifier:
NCT01506362
First received: January 3, 2012
Last updated: July 1, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Ulcerative Colitis
Drug: BL-7040
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by BioLineRx, Ltd.:

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 [ Time Frame: From Baseline to day 34 (end of treatment period) ] [ Designated as safety issue: No ]

    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:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: March 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.


  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506362

Locations
Israel
Soroka Medical Center
Be'er Sheva, Israel
Rambam Medical Center
Haifa, Israel
Hadassah medical center
Jerusalem, Israel
Shaare Zedek Medical center
Jerusalem, Israel
Sourasky Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
BioLineRx, Ltd.
Investigators
Principal Investigator: Sigal Fishman, MD Sourasky Medical Center
Principal Investigator: Eran Israeli, MD Hadassah medical center
Principal Investigator: Yehuda Chowers, MD Rambam Health Care Campus
Principal Investigator: Eran Goldin, MD Shaare Zedek Medical Center
Principal Investigator: Alex Fisch, MD Soroka Medical Center
  More Information

No publications provided

Responsible Party: BioLineRx, Ltd.
ClinicalTrials.gov Identifier: NCT01506362     History of Changes
Other Study ID Numbers: BL-7040.01
Study First Received: January 3, 2012
Results First Received: March 31, 2014
Last Updated: July 1, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by BioLineRx, Ltd.:
Ulcerative Colitis
IBD

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014