Efficacy, Pharmacodynamics, Safety and Tolerability of Oral BL-7040 in Patients With Moderately Active Ulcerative Colitis

A Phase 2 study testing BL-7040 in people with Ulcerative Colitis, run by BioLineRx, Ltd. at 5 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Ulcerative Colitis
What is being tested?: BL-7040
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 5 sitesIsrael
Study dates: Mar 2012to May 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Show all 16Show fewer

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).

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Israel5 sites

Soroka Medical Center
Beersheba
Rambam Medical Center
Haifa
Hadassah medical center
Jerusalem
Shaare Zedek Medical center
Jerusalem
Sourasky Medical Center
Tel Aviv

Other trials in Israel

About this study

Official title: 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).

Conditions: Ulcerative Colitis
Being tested: BL-7040
Keywords: Ulcerative Colitis, IBD
Medical subject headings: Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BL-7040Drug
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.

Study groups in NCT01506362
Study group	Role	What they receive
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. Receives: Drug: BL-7040

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: From Baseline to day 34 (end of treatment period)

Secondary outcomes (1)

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.
Measured: 5 weeks following first administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012May 2013

First posted10 Jan 2012 (estimated)
Study startMar 2012
Primary completionMay 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01506362
Sponsor's protocol ID: BL-7040.01
Status last verified: Mar 2014
First submitted: 3 Jan 2012
Last updated: 15 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
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All Ulcerative Colitis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of Oral BL-7040 in Patients With Moderately Active Ulcerative Colitis
ClinicalTrials.gov ID: NCT01506362
Acronym / sponsor ID: BL-7040.01
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis, IBD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: BioLineRx, Ltd.Industry (pharma, biotech, devices)
Study start: Mar 2012
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 10 Jan 2012 (estimated)
Results: Posted 1 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
A synthetic oligonucleotide for treatment of IBD.	Experimental	Drug: BL-7040BL-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.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BL-7040BL-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.	Drug	A synthetic oligonucleotide for treatment of IBD.

Primary outcome

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)
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

1 secondary outcome

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 and safety

Results posted to the registry on 1 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A Synthetic Oligonucleotide for Treatment of IBD.	22	16

Primary outcome: 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). Number. Unit: participants

Measure	A Synthetic Oligonucleotide for Treatment of IBD. n = 22
Value	8

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
A Synthetic Oligonucleotide for Treatment of IBD.	1 of 22 (4.5%)	13 of 22 (59.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Ulcerative Colitis

Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
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RecruitingObservational study
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RecruitingObservational study
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Enrolling by invitationPhase 4
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sigal Fishman, MD principal investigator

Sourasky Medical Center

Eran Israeli, MD principal investigator

Hadassah Medical Organization

Yehuda Chowers, MD principal investigator

Rambam Health Care Campus

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BL-7040 in people with Ulcerative Colitis, run by BioLineRx, Ltd. at 5 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01506362.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2014.