Ulcerative ColitisPhase 2NCT00572585
Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis
A Phase 2 study testing AEB071 in people with Ulcerative Colitis, run by Novartis Pharmaceuticals at 20 sites in 4 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- AEB071
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 20 sitesin 4 countries
- Study dates
- Apr 2010to Apr 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
Germany9 sites
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Hamburg, 22559
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Kiel, 24105
Novartis Investigative Site
Leipzig, 04105
Novartis Investigative Site
Lüneburg, 21339
Novartis Investigative Site
Minden, 32423
Novartis Investigative Site
Regensburg, 93053
Novartis Investigative Site
Stuttgart, 70376
United States7 sites
Novartis Investigative Site
Chesterfield Twp, Michigan, 48047
Novartis Investigative Site
Lafayette, Louisiana, 70501
Novartis Investigative Site
Mesa, Arizona, 85213
Novartis Investigative Site
Mobile, Alabama, 36608
Novartis Investigative Site
Oklahoma City, Oklahoma, 73104
Novartis Investigative Site
Topeka, Kansas, 66606
Novartis Investigative Site
Troy, Michigan, 48098
Denmark2 sites
Novartis Investigative Site
Aarhus, DK-8000
Novartis Investigative Site
Odense C, DK-5000
Poland2 sites
Novartis Investigative Site
Krakow, 30-307
Novartis Investigative Site
Poznan, 60-539
About this study
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
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
- Conditions
- Ulcerative Colitis
- Being tested
- AEB071, Placebo
- Keywords
- Ulcerative colitis, immunosuppressive therapy, AEB071, Modified Baron score, Partial Mayo score
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AEB071Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| AEB071 | Experimental | Not described Receives: Drug: AEB071 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: Throughout entire study
Measurement of drug concentrations in blood
Measured: During the dosing period only
Relationship between drug concentration in blood and disease activity
Measured: Dosing period only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2007 (estimated)
- Study startApr 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572585
- Sponsor's protocol ID
- CAEB071A2210
- Other IDs
- 2007-002542-38
- Status last verified
- Mar 2017
- First submitted
- 12 Dec 2007
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00572585
- Acronym / sponsor ID
- CAEB071A2210
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative colitis, immunosuppressive therapy, AEB071, Modified Baron score, Partial Mayo score
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 13 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AEB071 | Experimental | Drug: AEB071 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AEB071 | Drug | AEB071 |
| Placebo | Drug | Placebo |
Primary outcome
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
Time frame: Partial Mayo Score throughout entire study, biopsy at end of dosing period
3 secondary outcomes
Safety and tolerability assessments (vital signs, electrocardiogram [ECG], blood samples, serious adverse events, adverse events)
Time frame: Throughout entire study
Measurement of drug concentrations in blood
Time frame: During the dosing period only
Relationship between drug concentration in blood and disease activity
Time frame: Dosing period only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Results for CAEB071A2210 from the Novartis Clinical Trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AEB071 in people with Ulcerative Colitis, run by Novartis Pharmaceuticals at 20 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany, United States, Denmark, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Partial Mayo Score throughout entire study, biopsy at end of dosing period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.