Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00572585

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the efficacy, safety and tolerability of AEB071 in the treatment of active, moderate to severe ulcerative colitis in patients who have failed conventional therapy using mesalamine or steroids

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Drug: AEB071 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double Blind, Placebo Controlled, Parallel Group Design Study to Explore the Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AEB071	Drug: AEB071
Placebo Comparator: Placebo	Drug: Placebo

Arm

Intervention/Treatment

Experimental: AEB071

Drug: AEB071

Placebo Comparator: Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Rate of induction of remission after 28 days of treatment (using the Partial Mayo Score and the Modified Baron Score), also an Endoscopic biopsy will be taken [Partial Mayo Score throughout entire study, biopsy at end of dosing period]

Secondary Outcome Measures

Safety and tolerability assessments (vital signs, electrocardiogram [ECG], blood samples, serious adverse events, adverse events) [Throughout entire study]
Measurement of drug concentrations in blood [During the dosing period only]
Relationship between drug concentration in blood and disease activity [Dosing period only]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18-75 years males and females
Female subjects of childbearing potential must be using two methods of contraception
Active, moderate to severe disease
Poor response to or no toleration of conventional therapy (e.g. steroids, mesalamine)
Good communication with the investigator, understanding and compliance with the requirements of the study and written informed consent

Exclusion Criteria:

Allergy to the drug
Very low or high body weight
Ongoing treatment with specific other medication (e.g. antibiotics)
Diagnosis of primary sclerosing cholangitis
Renal impairment
Toxic megacolon
Presence or history of specific other diseases, cancer, cardiac abnormalities, abnormal laboratory findings
History of alcohol or drug abuse
Pregnant or breastfeeding women
Positive HIV, Hepatitis B or Hepatitis C test result

Other protocol-defined inclusion/exclusion criteria do apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Mobile	Alabama	United States	36608
2	Novartis Investigative Site	Mesa	Arizona	United States	85213
3	Novartis Investigative Site	Topeka	Kansas	United States	66606
4	Novartis Investigative Site	Lafayette	Louisiana	United States	70501
5	Novartis Investigative Site	Chesterfield Twp	Michigan	United States	48047
6	Novartis Investigative Site	Troy	Michigan	United States	48098
7	Novartis Investigative Site	Oklahoma City	Oklahoma	United States	73104
8	Novartis Investigative Site	Odense C		Denmark	DK-5000
9	Novartis Investigative Site	Århus		Denmark	DK-8000
10	Novartis Investigative Site	Berlin		Germany	10117
11	Novartis Investigative Site	Hamburg		Germany	22559
12	Novartis Investigative Site	Hannover		Germany	30625
13	Novartis Investigative Site	Kiel		Germany	24105
14	Novartis Investigative Site	Leipzig		Germany	04105
15	Novartis Investigative Site	Lüneburg		Germany	21339
16	Novartis Investigative Site	Minden		Germany	32423
17	Novartis Investigative Site	Regensburg		Germany	93053
18	Novartis Investigative Site	Stuttgart		Germany	70376
19	Novartis Investigative Site	Kraków		Poland	30-307
20	Novartis Investigative Site	Poznan		Poland	60-539