NCT00572585

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2010

Geographic Reach
4 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2007

Completed
2.3 years until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

December 22, 2020

Status Verified

March 1, 2017

Enrollment Period

2 years

First QC Date

December 12, 2007

Last Update Submit

December 15, 2020

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitisimmunosuppressive therapyAEB071Modified Baron scorePartial Mayo score

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

AEB071

EXPERIMENTAL
Drug: AEB071

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AEB071DRUG
AEB071
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Novartis Investigative Site

Mobile, Alabama, 36608, United States

Location

Novartis Investigative Site

Mesa, Arizona, 85213, United States

Location

Novartis Investigative Site

Topeka, Kansas, 66606, United States

Location

Novartis Investigative Site

Lafayette, Louisiana, 70501, United States

Location

Novartis Investigative Site

Chesterfield Twp, Michigan, 48047, United States

Location

Novartis Investigative Site

Troy, Michigan, 48098, United States

Location

Novartis Investigative Site

Oklahoma City, Oklahoma, 73104, United States

Location

Novartis Investigative Site

Aarhus, DK-8000, Denmark

Location

Novartis Investigative Site

Odense C, DK-5000, Denmark

Location

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Hamburg, 22559, Germany

Location

Novartis Investigative Site

Hanover, 30625, Germany

Location

Novartis Investigative Site

Kiel, 24105, Germany

Location

Novartis Investigative Site

Leipzig, 04105, Germany

Location

Novartis Investigative Site

Lüneburg, 21339, Germany

Location

Novartis Investigative Site

Minden, 32423, Germany

Location

Novartis Investigative Site

Regensburg, 93053, Germany

Location

Novartis Investigative Site

Stuttgart, 70376, Germany

Location

Novartis Investigative Site

Krakow, 30-307, Poland

Location

Novartis Investigative Site

Poznan, 60-539, Poland

Location

Related Links

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

sotrastaurin

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2007

First Posted

December 13, 2007

Study Start

April 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

December 22, 2020

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(9)PL(2)US(7)DK(2)