Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01506362 | Efficacy, Pharmacodynamics, Safety and Tolerability of Oral BL-7040 in Patients With Moderately Active Ulcerative Colitis | PHASE2 | COMPLETED | 22 | — | — | Mar 1, 2012 | May 1, 2013 | Jul 15, 2014 | 5 | Israel |
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
| Arm | Type | Description |
|---|---|---|
| A synthetic oligonucleotide for treatment of IBD. | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| BL-7040 | DRUG | 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. |
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 ...