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Ulcerative ColitisPhase 2NCT01336465

Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis

A Phase 2 study testing rhuMAb Beta7 in people with Ulcerative Colitis, run by Genentech, Inc. at 51 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This Phase II study is a randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of rhuMAb Beta7 in patients with moderate to severe ulcerative colitis. 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?
rhuMAb Beta7
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
51 sitesin 11 countries
Study dates
Sep 2011to Jun 2013
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

  • Diagnosis of moderate to severe ulcerative colitis outpatient
  • Disease duration at time of screening of >/= 12 weeks

Who cannot join

  • Extensive colonic resection or subtotal or total colectomy
  • Presence of an ileostomy or colostomy
  • Moderate to severe anemia
  • A history or evidence of colonic mucosal dysplasia
  • Pregnant or lactating
  • Significant uncontrolled co-morbidity, such as neurological, cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal (GI) disorders
Show all 15Show fewer
  • Significant screening ECG abnormalities, including evidence of acute myocardial infarction, complete left bundle branch block, second-degree heart block, or complete heart block
  • Poorly controlled diabetes
  • Impaired renal function
  • Impaired hepatic function in the absence of a diagnosis of primary sclerosing cholangitis
  • Positive tests for antibodies indicating active or prior infection with HIV or hepatitis B (HBV) or C (HCV)
  • Positive screening test for latent mycobacterium tuberculosis (TB) infection
  • Demyelinating disease
  • Received any investigational treatment within 12 weeks prior to initiation of study treatment
  • Previous exposure to rhuMAb Beta7

Trial locations and contacts

51 sites in 11 countries.

51 sites in 11 countries

United States8 sites

  • Study site

    Ann Arbor, Michigan, 48109-0682

  • Study site

    Atlanta, Georgia, 30308

  • Study site

    Chevy Chase, Maryland, 20815

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Gainesville, Florida, 32610

  • Study site

    Great Neck, New York, 11021

  • Study site

    Rochester, Minnesota, 55905

  • Study site

    San Diego, California, 92103

Other trials in United States

Australia5 sites

  • Study site

    Clayton, Victoria, 3168

  • Study site

    Fitzroy, Victoria, 3065

  • Study site

    Garran, Australian Capital Territory, 2605

  • Study site

    Melbourne, Victoria, 3181

  • Study site

    Parkville, Victoria, 3050

Other trials in Australia

Germany5 sites

  • Study site

    Berlin, 13353

  • Study site

    Hanover, 30625

  • Study site

    Kiel, 24105

  • Study site

    Minden, 32423

  • Study site

    Ulm, 89081

Other trials in Germany

Hungary5 sites

  • Study site

    Budapest, 1073

  • Study site

    Budapest, 1136

  • Study site

    Gyöngyös, 3200

  • Study site

    Győr, 9024

  • Study site

    Mosonmagyaróvár, 9200

Other trials in Hungary

Israel5 sites

  • Study site

    Beersheba, 84105

  • Study site

    Haifa, 31096

  • Study site

    Jerusalem, 91031

  • Study site

    Ramat Gan, 52621

  • Study site

    Tel Aviv, 64239

Other trials in Israel

New Zealand5 sites

  • Study site

    Auckland, 1023

  • Study site

    Auckland, 1640

  • Study site

    Christchurch, 8011

  • Study site

    Dunedin, 9054

  • Study site

    Takapuna, 0620

Other trials in New Zealand

Belgium4 sites

  • Study site

    Bonheiden, 2820

  • Study site

    Ghent, 9000

  • Study site

    Leuven, 3000

  • Study site

    Liège, 4000

Other trials in Belgium

Canada4 sites

  • Study site

    Edmonton, Alberta, T6G 2X8

  • Study site

    Edmonton, Alberta, V6Z 1Y6

  • Study site

    London, Ontario, N6A 5W9

  • Study site

    Woodbridge, Ontario, L4L 4Y7

Other trials in Canada

Czechia4 sites

  • Study site

    Hradec Králové, 500 12

  • Study site

    Náchod, 547 01

  • Study site

    Ostrava - Poruba, 708 52

  • Study site

    Zlín, 762 75

Other trials in Czechia

United Kingdom4 sites

  • Study site

    Harrow, HA1 3UJ

  • Study site

    London, N6A 4L6

  • Study site

    London, SW10 9NH

  • Study site

    Newcastle upon Tyne, NE1 4LP

Other trials in United Kingdom

Spain2 sites

  • Study site

    Barcelona, Barcelona, 08003

  • Study site

    Barcelona, Barcelona, 08036

Other trials in Spain

About this study

Official title: Phase II Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis

This Phase II study is a randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of rhuMAb Beta7 in patients with moderate to severe ulcerative colitis.

Being tested
placebo, rhuMAb Beta7
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • placeboDrug

    Repeating subcutaneous injection

  • rhuMAb Beta7Drug

    Repeating subcutaneous injection

Study groups in NCT01336465
Study groupRoleWhat they receive
rhuMAb Beta7ExperimentalNot described
Receives: Drug: rhuMAb Beta7
placeboPlacebo comparatorNot described
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point

    Measured: Week 10

Secondary outcomes (3)

  1. Clinical response as defined by at least a 3-point decrease and 30% reduction from baseline in MCS and a >/=1-point decrease in rectal bleeding subscore or absolute rectal bleeding score of 0 or 1

    Measured: Week 6 and Week 10

  2. Clinical remission defined by a MCS </= 2 with no individual subscore exceeding 1 point

    Measured: Week 6

  3. Proportion of patients with endoscopic score and rectal bleeding score of 0

    Measured: Week 6 and Week 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionSep 2012
  4. Study completionJun 2013

Resources

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
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01336465
Sponsor's protocol ID
ABS4986g
Other IDs
GP27778
Status last verified
Aug 2016
First submitted
14 Apr 2011
Last updated
12 Aug 2016
Results posted
No

Publications

  • Vermeire S, O'Byrne S, Keir M, Williams M, Lu TT, Mansfield JC, Lamb CA, Feagan BG, Panes J, Salas A, Baumgart DC, Schreiber S, Dotan I, Sandborn WJ, Tew GW, Luca D, Tang MT, Diehl L, Eastham-Anderson J, De Hertogh G, Perrier C, Egen JG, Kirby JA, van Assche G, Rutgeerts P. Etrolizumab as induction therapy for ulcerative colitis: a randomised, controlled, phase 2 trial. Lancet. 2014 Jul 26;384(9940):309-18. doi: 10.1016/S0140-6736(14)60661-9. Epub 2014 May 9.

    PubMed 24814090

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rhuMAb Beta7 in people with Ulcerative Colitis, run by Genentech, Inc. at 51 sites in 11 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 2 inclusion and 15 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 12 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Australia, Germany, Hungary, Israel and 6 more countries. 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?

Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point (time frame: Week 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01336465, which also lists 1 linked publication.

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 12 Aug 2016.

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