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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00572585

Enrollment

Registered

2007-12-13

Start date

2010-04-30

Completion date

2012-04-30

Last updated

2020-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis, immunosuppressive therapy, AEB071, Modified Baron score, Partial Mayo score

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

Interventions

DRUGAEB071

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Denmark, Germany, Poland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026