Ulcerative Colitis, Active ModeratePhase 2NCT01671956
Evaluation of Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis
A Phase 2 study testing Bertilimumab in people with Ulcerative Colitis, Active Moderate and Ulcerative Colitis, Active Severe, run by Alexion Pharmaceuticals, Inc. at 6 sites in Israel.
Trial summary
This is a randomized, double blind, placebo-controlled, parallel group multi-center study in adult participants with active moderate to severe UC. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis, Active Moderate, Ulcerative Colitis, Active Severe
- What is being tested?
- Bertilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 6 sitesIsrael
- Study dates
- 31 Jul 2015to 14 Nov 2018
- 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
- Males or females, 18 to 70 years of age inclusive.
- Diagnosed with active moderate to severe UC per standard diagnostic criteria for a minimum of 3 months:
- Mayo score of 6-12 (inclusive) at the Screening Visit
- Endoscopic evidence of active mucosal disease, as assessed by flexible sigmoidoscopy, with an Endoscopic Finding Sub-score of ≥2 (assessed centrally)
- Rectal Bleeding Sub-score of ≥1
- Physician's Global Assessment (PGA) Sub-score of ≥2.
- Levels of eotaxin-1 in biopsied colon tissue of ≥100 pg/mg protein.
- Adequate cardiac, renal and hepatic function as determined by the Investigator and demonstrated by screening laboratory evaluations and physical examination results; these findings must all be within normal limits or judged not clinically significant by the Investigator.
Who cannot join
- History of colonic or rectal surgery other than hemorrhoidal surgery or appendectomy.
- Currently receiving total parenteral nutrition (TPN).
- Positive Clostridium difficile toxin stool assay.
- Tested positive for active/latent mycobacterium tuberculosis (TB) infection.
- Pregnant or breast-feeding, or plan to become pregnant during the study.
- Males who are young and childless or planning to have more children in the future.
Show all 39Show fewer
- Known hypersensitivity to bertilimumab or any of the drug excipients.
- History of infection requiring administration of any IV antibiotic, antiviral or antifungal medication within 30 days of Screening or any oral anti-infective agent within 14 days of Screening.
- Severe UC evidenced by the following signs of toxicity: heart rate >100 beats/min at rest, temperature >37.8°C, hemoglobin <10.0 g/dL.
- Ulcerative proctitis, defined as disease limited to less than 15 cm from the anal verge.
- Received a vaccine or other immunostimulator within 4 weeks prior to screening.
- Use of >4.8 g mesalazine or equivalent within 2 weeks prior to the screening visit. Mesalazine ≤4.8 g is allowed if the dose during the 2 weeks prior to the screening visit was stable.
- Use of systemic corticosteroids exceeding the equivalent of 20 mg/day of prednisone within four weeks prior to the screening visit (see Section 6.9.1).
- Change in dose of immunosuppressive drugs (e.g., corticosteroids, 6-mercaptopurine [6-MP], azathioprine) within four weeks prior to the screening visit.
- Use of TNF-blockers (e.g., infliximab or adalimumab) within 60 days of the screening visit.
- Use of chronic non-steroidal anti-inflammatory (NSAID) therapy. Occasional use of NSAIDs or acetaminophen for headache, arthritis, myalgias, menstrual cramps, etc., or daily use of low dose (81-162 mg) aspirin for cardiovascular prophylaxis is allowed.
- Patients diagnosed with:
- Crohn's disease
- Diverticulitis or diverticulosis
- Indeterminate colitis (inability to distinguish between UC and Crohn's disease [as assessed by the Investigator])
- Microscopic colitis (collagenous or lymphocytic colitis)
- Ischemic or infectious colitis
- Clostridium difficile colitis within 90 days of the screening visit
- Parasitic disease within 90 days of the screening visit
- Systemic fungal infection within 90 days of the screening visit.
- History of positive serology of hepatitis B or C, or human immunodeficiency virus (HIV) infection.
- Congenital or acquired immunodeficiency (e.g., common variable immunodeficiency, organ transplantation).
- Clinically significant abnormal laboratory test results, unless regarded by the Investigator as related to UC, including but not limited to:
- Hemoglobin level <10.0 g/dL
- White blood cell count < 3 x 103/µL
- Lymphocyte count < 0.5 x 103/µL
- Platelet count <100 x 103/µL or >1200 x 103/µL
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 the upper limit of normal (ULN)
- Alkaline phosphatase >3 ULN
- Serum creatinine >2 ULN.
- Active abuse of alcohol or drugs.
- Known malignancy or history of malignancy that could reduce life expectancy.
- Any condition, which in the opinion of the Investigator, would place the patient at an unacceptable risk if participating in the study protocol.
- Participation in a clinical trial of an investigational (unapproved) product
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Israel6 sites
Research Site
Afula
Research Site
Holon, 58100
Research Site
Jerusalem, 91031
Research Site
Jerusalem, 91120
Research Site
Kfar Saba, 44299
Research Site
Tel Aviv, 64239
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study Designed to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Profile of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis
This is a randomized, double blind, placebo-controlled, parallel group multi-center study in adult participants with active moderate to severe UC.
- Being tested
- Bertilimumab, Placebo
- Keywords
- IBD, UC, Colitis, Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative, Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BertilimumabBiological
IV infusion over 30 minutes, at Day 0, Day 14 and Day 28
PlaceboBiological
IV infusion over 30 minutes, at Day 0, Day 14 and Day 28
| Study group | Role | What they receive |
|---|---|---|
| Bertilimumab | Experimental | Bertilimumab 10 mg/kg will be administered by IV infusion over 30 minutes Receives: Biological: Bertilimumab |
| Placebo | Placebo comparator | Phosphate buffered saline (PBS) placebo will be administered by IV infusion over 30 minutes. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Total Mayo Score at Day 56
The Total Mayo score is an instrument designed to measure disease activity of ulcerative colitis and ranged from 0 (normal or inactive disease) to 12 (severe disease). It is a composite of 4 sub-scores: Stool frequency sub-score, rectal bleeding sub-score, endoscopic finding sub-score, and physician's global assessment sub-score, each of which ranges from 0 (normal) to 3 (severe disease). The sub-scores were summed to give a total score that ranged from 0-12. Change in mayo score was calculated as the sum of scores at Day 56 minus the sum of scores at Baseline divided by 14 for bertilimumab arm and sum of scores at Day 56 minus the sum of scores at Baseline divided by 6 for placebo arm.
Measured: Baseline, Day 56
Secondary outcomes (1)
Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) Score at Day 56
The UCEIS is the validated index for the assessment of overall endoscopic activity. The model incorporated the vascular pattern score (0-2), the presence of bleeding score (0-3) and the presence of erosions and ulcers score (0-3). The total score ranged from 0-8. Higher scores indicated more severe disease. Change in mayo score was calculated as the sum of scores at Day 56 minus the sum of scores at Baseline divided by 15 for bertilimumab arm and sum of scores at Day 56 minus the sum of scores at Baseline divided by 6 for placebo arm.
Measured: Baseline, Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study start31 Jul 2015
- Primary completion31 Aug 2018
- Study completion14 Nov 2018
Why it stopped: Sponsor Decision.
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 Colitis, Active ModerateStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Immune Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671956
- Sponsor's protocol ID
- Immune/BRT/UC-01
- Status last verified
- Nov 2025
- First submitted
- 9 Aug 2012
- Last updated
- 25 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study Designed to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Profile of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01671956
- Acronym / sponsor ID
- Immune/BRT/UC-01
- Keywords
- IBD, UC, Colitis, Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Immune Pharmaceuticals
- Study start
- 31 Jul 2015 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 14 Nov 2018 (actual)
- First posted
- 24 Aug 2012 (estimated)
- Results
- Posted 25 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double blind, placebo-controlled, parallel group multi-center study in adult participants with active moderate to severe UC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bertilimumab | Experimental | Biological: BertilimumabBertilimumab 10 mg/kg will be administered by IV infusion over 30 minutes |
| Placebo | Placebo comparator | Biological: PlaceboPhosphate buffered saline (PBS) placebo will be administered by IV infusion over 30 minutes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males or females, 18 to 70 years of age inclusive.
- Diagnosed with active moderate to severe UC per standard diagnostic criteria for a minimum of 3 months:
- Levels of eotaxin-1 in biopsied colon tissue of ≥100 pg/mg protein.
- Adequate cardiac, renal and hepatic function as determined by the Investigator and demonstrated by screening laboratory evaluations and physical examination results; these findings must all be within normal limits or judged not clinically significant by the Investigator.
Key exclusion criteria (39 listed)
- History of colonic or rectal surgery other than hemorrhoidal surgery or appendectomy.
- Currently receiving total parenteral nutrition (TPN).
- Positive Clostridium difficile toxin stool assay.
- Tested positive for active/latent mycobacterium tuberculosis (TB) infection.
- Pregnant or breast-feeding, or plan to become pregnant during the study.
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 |
|---|---|---|
| BertilimumabIV infusion over 30 minutes, at Day 0, Day 14 and Day 28 | Biological | Bertilimumab |
| PlaceboIV infusion over 30 minutes, at Day 0, Day 14 and Day 28 | Biological | Placebo |
Primary outcome
Change From Baseline in Total Mayo Score at Day 56
Time frame: Baseline, Day 56
The Total Mayo score is an instrument designed to measure disease activity of ulcerative colitis and ranged from 0 (normal or inactive disease) to 12 (severe disease). It is a composite of 4 sub-scores: Stool frequency sub-score, rectal bleeding sub-score, endoscopic finding sub-score, and physician's global assessment sub-score, each of which ranges from 0 (normal) to 3 (severe disease). The sub-scores were summed to give a total score that ranged from 0-12. Change in mayo score was calculated as the sum of scores at Day 56 minus the sum of scores at Baseline divided by 14 for bertilimumab arm and sum of scores at Day 56 minus the sum of scores at Baseline divided by 6 for placebo arm.
1 secondary outcome
Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) Score at Day 56
Time frame: Baseline, Day 56
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Ulcerative Colitis, Active Moderate
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Active, not recruitingPhase 3
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis
RecruitingPhase 3
A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
Moderately to Severely Active Ulcerative Colitis
RecruitingPhase 2
LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
RecruitingPhase 3
Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study
Ulcerative Colitis, Obesity or Overweight
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.
The record lists no contact. Use the official record to reach the sponsor.
6 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 Bertilimumab in people with Ulcerative Colitis, Active Moderate and Ulcerative Colitis, Active Severe, run by Alexion Pharmaceuticals, Inc. at 6 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 8 inclusion and 39 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: stopped early, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. Some participants in this study may receive a placebo. 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 25 Nov 2025). 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?
Change From Baseline in Total Mayo Score at Day 56 (time frame: Baseline, Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2025.