Efficacy, Pharmacodynamics, Safety and Tolerability of Or... | NCT01506362

NCT01506362

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Drug: BL-7040

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 to 2 stools per day more than normal 3 to 4 stools more than normal > or = to 5 stools more than normal Rectal bleeding (subscore 0-3) 0: No blood seen Streaks of blood with stool less than half the time Obvious blood with stool most of the time 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 Mild disease Moderate disease Severe disease	From Baseline to day 34 (end of treatment period)

Secondary Outcomes

Measure	Description	Time Frame
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.		5 weeks following first administration

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female, age 18 to 70.
Moderately active ulcerative colitis as defined by Mayo score of ≥ 5 and ≤ 9 within 9 days of first day of study treatment.
Diagnosis of ulcerative colitis ≥ 3 months prior to study entry.
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.
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.
Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment

Exclusion Criteria:

Diagnosis of indeterminate colitis or clinical findings suggestive of Crohn's disease.
Subjects with ulcerative proctitis.
A diagnosis of ischemic colitis, fulminant colitis or toxic megacolon.
Evidence of bowel infection.
Body temperature ≥ 38°C at screening.
Evidence of abdominal abscess at the initial screening visit.
Extensive colonic resection, subtotal or total colectomy.
Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
Receiving non-permitted IBD therapies
History of or current peptic ulcer disease.
Pregnant or lactating women.
Chronic hepatitis B or C infection or HIV seropositivity.
Current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurological disease.
Drug or alcohol abuse (by history).
Patients participating in any other clinical trials.
Patients with inability to communicate well with the Investigators and staff (i.e., language problem, poor mental development or impaired cerebral function).

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Sigal Fishman, MD	Sourasky Medical Center	Principal Investigator
Eran Israeli, MD	Hadassah Medical Organization	Principal Investigator
Yehuda Chowers, MD	Rambam Health Care Campus	Principal Investigator
Eran Goldin, MD	Shaare Zedek Medical Center	Principal Investigator
Alex Fisch, MD	Soroka University Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Soroka Medical Center		Beersheba			Israel
Rambam Medical Center

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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

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 to 2 stools per day more than normal
3 to 4 stools more than normal
> or = to 5 stools more than normal

Rectal bleeding (subscore 0-3) 0: No blood seen

Streaks of blood with stool less than half the time
Obvious blood with stool most of the time
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

Mild disease
Moderate disease
Severe disease

Posted

Number

participants

From Baseline to day 34 (end of treatment period)

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases