A Randomized, Double-Blind, Placebo-Controlled Study Designed to Evaluate the Safety, Clinical Efficacy, and Pharmacokinetic Profile of Bertilimumab in Subjects With Active Moderate to Severe Ulcerative Colitis - Full Text View

Purpose

The study objectives are:

To evaluate the safety and clinical efficacy of Bertilimumab administered to subjects with active moderate to severe UC
To evaluate the bioactivity, pharmacokinetics (PK) and pharmacodynamics (PD) effects of Bertilimumab to subjects with active moderate to severe UC.

Study design:

This will be is a randomized, double blind, placebo-controlled, parallel group multi-center study in adult subjects with active moderate to severe UC . Eligible subjects will be randomly assigned to one of two treatment groups, bertilimumab or matching placebo.

The study will consist of three periods: a screening period of up to two weeks, a 4-week double-blind treatment period, and approximately 9-week safety and efficacy follow-up period.

Bertilimumab is a recombinant human IgG4 monoclonal antibody that neutralizes human eotaxin-1 (eotaxin). Bertilimumab will be administered every other week for 4-weeks, by IV infusion over 30 minutes.

Condition	Intervention	Phase
Active Moderate to Severe Ulcerative Colitis	Biological: Bertilimumab Biological: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study Designed to Evaluate the Safety, Clinical Efficacy, and Pharmacokinetic Profile of Bertilimumab in Subjects With Active Moderate to Severe Ulcerative Colitis

Resource links provided by NLM:

Genetics Home Reference related topics: ulcerative colitis

MedlinePlus related topics: Ulcerative Colitis

U.S. FDA Resources

Further study details as provided by Immune Pharmaceuticals:

Primary Outcome Measures:

Clinical response [ Time Frame: week 6 ] [ Designated as safety issue: No ]
- A decrease in Mayo score from baseline of at least 3 points and at least 30% AND
- Either a decrease in the sub-score for rectal bleeding of at least 1 point, or rectal bleeding sub-score of 0 or 1.

Secondary Outcome Measures:

Number of Adverse events [ Time Frame: day 0,14,28,35,42,66,90 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:

Terminal half life of Bertilimumab [ Time Frame: Day 0,14,28 predose and 0.5 and 4 hours post dose and on day 35,42,66, 90 ] [ Designated as safety issue: No ]

Estimated Enrollment:

90

Arms	Assigned Interventions
Experimental: Bertilimumab Bertilimumab is a recombinant human IgG4 monoclonal antibody that neutralizes human eotaxin-1. Bertilimumab will be administered every other week for 4 weeks by IV infusion	Biological: Bertilimumab
Placebo Comparator: Placebo Phosphate buffered saline (PBS) placebo will be administered every other week for 4 weeks by IV infusion.	Biological: Placebo

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females, 18 to 70 years of age inclusive
Diagnosed with moderate to severely active UC per standard diagnostic criteria for a minimum of 3 months.
High levels of eotaxin-1 in biopsied colon tissue of ≥100 pg/mL
Female subjects with childbearing potential must agree to use effective contraceptive consistently from 30 days before screening through study completion.
Male subjects must agree to use effective contraceptive consistently throughout the study.

Exclusion Criteria:

History of colonic or rectal surgery other than hemorrhoidal surgery or appendectomy
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
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 >90 beats/min at rest, temperature >37.8 degree, hemoglobin <10.5 g/dL
Ulcerative proctitis, defined as disease limited to less than 15 cm from the anal verge
Subject diagnosed with:Crohn's disease;Indeterminate colitis (inability to distinguish between UC and Crohn's disease);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
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)
Active abuse of alcohol or drugs
known malignancy or history of malignancy that would reduce life expectancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671956

Contacts

Contact: Eran Goldin, Prof.

02-6555916

erang@szmc.org.il

Locations

Israel
Shaare Tzedek Medical Central	Not yet recruiting
Jerusalem, Israel, 91031
Contact: Eran Goldin, Prof. 02-6555916 erang@szmc.org.il

Sponsors and Collaborators

Immune Pharmaceuticals

More Information

No publications provided

Responsible Party:	Immune Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01671956 History of Changes
Other Study ID Numbers:	C2a/BRT/UC-01
Study First Received:	August 9, 2012
Last Updated:	March 3, 2013
Health Authority:	Israel: Ministry of Health

Additional relevant MeSH terms:

Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases

Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013