Evaluation of Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis

NCT01671956 | Terminated Phase 2 Results

• 1 other identifier: Immune/BRT/UC-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 6

Brief Summary

This is a randomized, double blind, placebo-controlled, parallel group multi-center study in adult participants with active moderate to severe UC.

Conditions

Ulcerative Colitis, Active Moderate; Ulcerative Colitis, Active Severe

Keywords

IBD; UC; Colitis; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Day 56

Secondary Outcomes (1)

• Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) Score at Day 56

  Baseline, Day 56

Study Arms (2)

Bertilimumab

EXPERIMENTAL

Bertilimumab 10 mg/kg will be administered by IV infusion over 30 minutes

Biological: Bertilimumab

Placebo

PLACEBO COMPARATOR

Phosphate buffered saline (PBS) placebo will be administered by IV infusion over 30 minutes.

Biological: Placebo

Interventions

Bertilimumab BIOLOGICAL

IV infusion over 30 minutes, at Day 0, Day 14 and Day 28

Bertilimumab

Placebo BIOLOGICAL

IV infusion over 30 minutes, at Day 0, Day 14 and Day 28

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead
• Immune Pharmaceuticals: collaborator

Study Sites (6)

Research Site

Afula, Israel

Location

Research Site

Holon, 58100, Israel

Location

Research Site

Jerusalem, 91031, Israel

Location

Research Site

Jerusalem, 91120, Israel

Location

Research Site

Kfar Saba, 44299, Israel

Location

Research Site

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Colitis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Limitations and Caveats

Study conducted by Immune Pharmaceuticals Inc. and was acquired by Alexion Pharmaceuticals, Inc after study completion, database lock, and report generation. Study was terminated early due to sponsor decision.

Results Point of Contact

• Title: Alexion Pharmaceuticals, Inc.
• Organization: Alexion Pharmaceuticals, Inc.

clinicaltrials@alexion.com

855-752-2356

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2012
• First Posted: August 24, 2012
• Study Start: July 31, 2015
• Primary Completion: August 31, 2018
• Study Completion: November 14, 2018
• Last Updated: November 25, 2025
• Results First Posted: November 25, 2025

Record last verified: 2025-11

Locations

IL (6)