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

January 3, 2012
July 1, 2014
March 2012
May 2013   (final data collection date for primary outcome 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 [ 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
Change in clinical disease activity, assessed using the Mayo score, between baseline (within 7 days of the first day of treatment) and completion of study treatment. [ Time Frame: 7 days following initial administration ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01506362 on ClinicalTrials.gov Archive Site
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 ]
Adverse Events Will be Detected and Stratified According to Severity, Relatedness to Study Medication and Body System. [ Time Frame: 5 weeks following first administration ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Efficacy, Pharmacodynamics, Safety and Tolerability of Oral BL-7040 in Patients With Moderately Active Ulcerative Colitis
An Open-Label Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of Oral BL-7040 in Patients With Moderately Active Ulcerative Colitis

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

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ulcerative Colitis
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.

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.
Intervention: Drug: BL-7040
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
May 2013
May 2013   (final data collection date for primary outcome measure)

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).
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01506362
BL-7040.01
No
BioLineRx, Ltd.
BioLineRx, Ltd.
Not Provided
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
BioLineRx, Ltd.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP