The objective of the proposed study is to determine whether BL-7040 demonstrates clinical efficacy in patients with inflammatory bowel disease (IBD).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
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.
Soroka Medical Center
Beersheba, Israel
Rambam Medical Center
Haifa, Israel
Hadassah medical center
Jerusalem, Israel
Shaare Zedek Medical center
Jerusalem, Israel
Sourasky Medical Center
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
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
Time frame: From Baseline to day 34 (end of treatment period)
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
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Tel Aviv, Israel