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
Results First Received: March 31, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ulcerative Colitis
Intervention: Drug: BL-7040

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

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.


Participant Flow:   Overall Study
    A Synthetic Oligonucleotide for Treatment of IBD.  
STARTED     22  
COMPLETED     16  
NOT COMPLETED     6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.

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.


Baseline Measures
    A Synthetic Oligonucleotide for Treatment of IBD.  
Number of Participants  
[units: participants]
  22  
Age  
[units: years]
Mean ± Standard Deviation
  33.9  ± 13.9  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     21  
>=65 years     1  
Gender  
[units: participants]
 
Female     7  
Male     15  
Region of Enrollment  
[units: participants]
 
Israel     22  



  Outcome Measures

1.  Primary:   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) ]

2.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Arnon Aharon
Organization: BioLineRx LTD
phone: 972-2-548-9100 ext 135
e-mail: arnona@biolinerx.com


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