Clinical trial NCT00572585: Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Ulcerative colitis
immunosuppressive therapy
AEB071
Modified Baron score
Partial Mayo score
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-12-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Partial Mayo Score throughout entire study, biopsy at end of dosing period
Secondary outcomes:
measure: Safety and tolerability assessments (vital signs, electrocardiogram [ECG], blood samples, serious adverse events, adverse events)
timeFrame: Throughout entire study
measure: Measurement of drug concentrations in blood
timeFrame: During the dosing period only
measure: Relationship between drug concentration in blood and disease activity
timeFrame: Dosing period only
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Mesa
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Topeka
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Lafayette
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Chesterfield Twp
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Troy
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Odense C
country: Denmark
facility: Novartis Investigative Site
city: Århus
country: Denmark
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Lüneburg
country: Germany
facility: Novartis Investigative Site
city: Minden
country: Germany
facility: Novartis Investigative Site
city: Regensburg
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Kraków
country: Poland
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: